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MINISTRY
OF HEALTH OF VIETNAM
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
02/VBHN-BYT
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Hanoi,
January 11, 2024
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DECREE
GUIDELINES FOR IMPLEMENTATION OF THE LAW ON PHARMACY
The Government’s Decree No. 54/2017/ND-CP
dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy,
which has been effective since July 01, 2017, is amended by:
The Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 on amendments to certain regulations relating
to business conditions under state management of the Ministry of Health, which
has been effective since November 12, 2018.
The Government’s Decree No.
88/2023/ND-CP dated December 11, 2023 amendments to Decree
No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation
of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to certain
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
Pursuant to the Law on
Government Organization dated June 19, 2015; Law dated November 22, 2019 on
Amendments to some Articles of the Law on Government Organization and Law on
Local Government Organization;
Pursuant to the Law on Pharmacy
dated April 06, 2016;
At the request of the Minister
of Health;
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Chapter I
GENERAL PROVISIONS
Article 1.
Scope and regulated entities
1. This Decree provides for
pharmacy practice certificate; pharmacy business; export and import of drugs;
marketing authorization of herbal materials, excipients, capsule shells;
assessment of overseas drug manufacturers; power, method and procedures for
recalling medicinal materials; handling of recalled medicinal materials;
documents and procedures for issuance of certification of drug advertisement
and measures for drug price management.
2. This Decree applies to
organizations and individuals in Vietnam and overseas whose operation involves
pharmacy in Vietnam.
Article 2.
Definitions
For the purpose of this Decree, the
terms below are construed as follows:
1. “drug information” means
collection and provisions of information about a drug, including indications,
contraindications, dose, uses, adverse effects and information relevant to
quality, safety and efficacy of the drug provided by a responsible facility in
order to provide information for pharmacy authorities, medical practitioners
and drug users.
2. 2 “pharmaceutical conference” means a conference where a drug
is introduced or drug-related issues are discussed among medical or
pharmaceutical practitioners
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4. “import price” is the customs
value of imported drug on the customs value declaration at a Vietnam’s port
after customs clearance is granted.
5. “prime cost” of a domestically
manufactured drug equals (=) the costs of raw materials, fuel, instruments,
energy plus (+) direct labour cost plus (+) depreciation of direct machinery
and equipment plus (+) manufacturing overhead plus (+) financing cost plus (+)
cost of sales plus (+) management cost minus (-) cost distributed to by
products (if any).
6. “wholesale price” is the selling
price among pharmacy business establishments or between a pharmacy business
establishment and a medical facility.
7. “intended wholesale price” is
the price declared by the drug importer, drug manufacturer or outsourcing
entity (in case of manufacturing outsourcing) to a competent authority.
8. “retail price” of a drug is the
price for selling the drug to buyers imposed by the drug retailer.
9. “retail margin” is the
difference between the buying price and selling price at a drug retailer.
10. “retail margin percent” is the
ratio (%) of retail margin to buying price at a drug retailer.
Chapter II
PHARMACY PRACTICE CERTIFICATE
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Article 3.
Application for the pharmacy practice certificate
1. An application for the pharmacy
practice certificate mentioned in Article 24 of the Law on Pharmacy consists
of:
a)3 The application form for the Pharmacy Practice Certificate
must be made by using form No.02 in Appendix I hereto;
b) Certified true copy of the
applicant’s qualification. If the qualification is issued overseas, its certified
true copy must be enclosed with an equivalence certification issued by a
competent authority specified in Clause 2 Article 18 hereof;
c) 4 (repealed)
d) The original copy or certified
true copy of the certificate of internship (Form 03 in Appendix I enclosed
herewith). If the internship took place in more than one facility, the
internship duration will be the total duration of internship at the facilities
according to the certificates of internship issued by such facilities;
dd) If the scope of practice
covered by the pharmacy practice certificate applied for requires different
internship durations and facilities, the application shall be enclosed with a
certificate of internship of one or several facilities that meet requirements
of each position. If the scope of practice covered by the pharmacy practice
certificate applied for requires the same internship durations and facilities,
the certificate of internship is not required;
e) The original copy or certified
true copy of the confirmation of examination result specified in Clause 2
Article 28 hereof if the pharmacy practice certificate has to be obtained after
passing an examination;
g)5 (repealed)
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3. Only 01 set of documents
specified in this Article is required.
Article 4.
Application for reissuance of the pharmacy practice certificate
1. An application for reissuance
the pharmacy practice certificate mentioned in Article 25 of the Law on
Pharmacy consists of:
a)6 The application form for re-issuance of the Pharmacy
Practice Certificate must be made by using form No. 04 in Appendix I hereto;
b) 7 (repealed)
2. Only 01 set of documents
specified in this Article is required.
Article 5.
Application for adjustment to the pharmacy practice certificate
1. An application for adjustment to
the pharmacy practice certificate mentioned in Article 26 of the Law on
Pharmacy consists of:
a) 8 Application form for amendments to the Pharmacy Practice
Certificate must be made by using form No. 05 in Appendix I hereto;
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c) If the applicant’s scope of
practice has to be adjusted, documents proving the adjustment: relevant
qualifications, certificate of internship as an appropriate pharmaceutical
facility.
2. The original copy or certified
true copy of the documents specified in Clause 1b and 1c of this Article.
3. The documents mentioned in
Clause 1b and 1c of this Article must be consularly legalized and enclosed with
notarized Vietnamese translations if issued by overseas competent authorities.
4. Only 01 set of documents
specified in this Article is required.
Article 6.
Procedures for issuing, reissuing and adjusting the pharmacy practice
certificate
1. The applicant for issuance,
reissuance or adjustment of the pharmacy practice certificate shall submit an
application directly or by post to:
a) The Ministry of Health if the
pharmacy practice certificate has to be obtained after passing an examination;
b) Department of Health of the
province if the pharmacy practice certificate may be granted without an
examination.
2. After receiving the application,
the receiving authority shall give the applicant form No. 01 in Appendix I
enclosed herewith.
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a) 9 The Pharmacy Practice Certificate must be issued within 15
days from the date written on the application receipt form (hereinafter
referred to as “the date of receipt”); if the application is rejected, provide
explanations in writing;
b) Issue the pharmacy practice
certificate within 05 working days from the date of receipt if certificate was
revoked according to Clause 3 Article 28 of the Law on Pharmacy; If the
application is rejected, provide written explanation;
c)10 Re-issue or amend the Pharmacy Practice Certificate
within 05 working days from the date of receipt; if the application is
rejected, provide explanations in writing.
4. If the application is not
satisfactory, the receiving authority shall request the applicant to complete
the application:
a) within 10 days from the date of
receipt of the application for issuance of the pharmacy practice certificate;
or
b) 05 working days from the date of
receipt of the application for reissuance or adjustment of the pharmacy
practice certificate.
5. After receiving the supplemented
application, the receiving authority shall give the applicant form No. 01 in
Appendix I enclosed herewith.
a) If the supplemented application
is still unsatisfactory, the receiving authority shall request the applicant to
complete it in accordance with Clause 4 of this Article;
b) If the supplemented application
is satisfactory, the receiving authority shall follow the instructions in
Clause 3 of this Article.
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7. Within 05 working days from the
date of issuance, reissuance or adjustment of the pharmacy practice
certificate, the receiving authority shall update the following information on
its website:
a) Full name, date of birth of the
holder of the pharmacy practice certificate;
b) Number of the pharmacy practice
certificate;
c) The scope of practice.
8. The pharmacy practice
certificate will be made into 02 copies. One of them will be given to the applicant,
the other retained by the issuing authority.
9. When a pharmacy practice
certificate is reissued or adjusted, the applicant shall return the old one.
In the cases where a pharmacy
practice certificate is lost, the applicant shall submit the Form No. 04 in
Appendix I enclosed herewith.
10. Specimen of the pharmacy
practice certificate:
a) The specimen of the pharmacy
practice certificate issued without an examination is Form No. 06 in Appendix I
enclosed herewith;
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11. The Minister of Health shall
specify the structure and operation of the advisory council responsible for
giving counsel on issuance of the pharmacy practice certificate (hereinafter
referred to as “certification advisory council”).
12. In the cases where a pharmacy
practice certificate is reissued according to Clause 8 Article 24 of the Law on
Pharmacy, the applicant is exempt from fees.
Article 7. Procedures
for revocation of the pharmacy practice certificate
1. When a pharmacy practice
certificate is revoked according to Clauses 1, 4, 5, 6, 7, 8, 9, 10, 11 Article
28 of the Law on Pharmacy:
Within 05 working days from the day
on which the proposal to revoke the pharmacy practice certificate is received
or from the discovery of the cases mentioned in Clauses 1, 4, 5, 6, 7, 8, 9,
10, 11 Article 28 of the Law on Pharmacy, the issuing authority shall revoke
the pharmaceutical practice certificate it issued, or respond the proposing
authority and provide explanation if such proposal is rejected.
2. When a pharmacy practice
certificate is revoked according to Clause 2 and Clause 3 Article 28 of the Law
on Pharmacy:
Within 05 working days from the day
on which the pharmacy practice certificate is found erroneous or the request
for revocation of the pharmacy practice certificate is received, the issuing
authority shall revoke the pharmaceutical practice certificate it issued, or
respond the requesting entity in writing and provide explanation if such
request is rejected.
3. Responsibilities of the issuing
and revoking authority:
a) Issue the decision to revoke the
pharmacy practice certificate;
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c) Update information about
revocation of the pharmacy practice certificate on its website;
d) The Ministry of Health and
Departments of Health of provinces shall post the decision on revocation of the
pharmacy practice certificate on their websites within 05 working days from the
day on which it is received from its issuer.
Section 2.
REFRESHER COURSES IN PHARMACY
Article 8. Institutions offering refresher training
courses in pharmacy 11
1. The institutions offering
refresher training courses must be one of the following organizations: a
vocational education institution licensed to provide training in medicine or
pharmacy; an education institution licensed to provide training in health
science; a research institute licensed to provide training in medicine or
pharmacy; an institution licensed to provide training for health workers or a
pharmacy association.
2. The institutions providing
refresher training courses in pharmacy must develop their training programs
with the following principal contents:
a) The training contents include:
- Professional knowledge;
- Pharmacy law and management;
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Article 9.12 (repealed)
Article 10.13 (repealed)
Article 11.14 (repealed)
Article 12.15 (repealed)
Article 13.16 (repealed)
Article 14.
Responsibilities of a refresher training institution
1.17 (repealed)
2. Make assessment and issue
certificates of completion of the refresher course according to Form No. 12 in
Appendix I enclosed herewith.
3.18 (repealed)
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Article 15.
Responsibilities of pharmacy authorities
1. The Ministry of Health shall:
a)20 Inspect and supervise the refresher training institutions
specified in Article 8 hereof;
b) Request Departments of Health to
submit periodic and unscheduled reports on management of refresher training
institutions.
2. The Department of Health of each
province shall:
a) 21 Inspect, supervise and cooperate with the pharmacy
refresher training institutions in its provinces in providing refresher
trainings in pharmacy;
b) Update the list of people who
have completed the refresher course at refresher training institutions in the
province on its website;
c) Publish the performance of
refresher training institutions in the province on its website.
Article 16.
Cost of refresher training in pharmacy
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Section 3.
DETERMINATION OF QUALIFICATIONS AND POSITIONS TO ISSUE THE PHARMACY PRACTICE
CERTIFICATE
Article 17.
Qualifications eligible for issuance of the pharmacy practice certificate
1. Bachelor’s degree in pharmacy
which is granted by a domestic educational institution and the position written
in which is “Dược sĩ” (“Pharmacist”), “Dược sĩ đại học” (“Bachelor of
Pharmacy”) or “Dược sĩ cao cấp” (“High-rank pharmacist”).
2. Bachelor’s degree in general
medicine which is granted by a domestic educational institution and the
position written in which is “Bác sĩ” (“Physician”) or “Bác sĩ đa khoa”
(“General physician”).
3. Bachelor’s degree in traditional
medicine or traditional pharmacy which is granted by a domestic educational
institution.
4. Bachelor’s degree in biology
which is granted by a domestic educational institution.
5. Bachelor’s degree in chemistry
which is granted by a domestic educational institution.
6. College degree in pharmacy which
is granted by a domestic educational institution.
7. Associate degree in pharmacy
which is granted by a domestic educational institution and the position written
in which is “Dược sĩ trung cấp” or “Dược sĩ trung học” (“pharmacy technician”).
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9. Associate degree in traditional
medicine or traditional pharmacy which is granted by a domestic educational
institution.
10. Basic diploma in pharmacy which
is granted by a domestic educational institution and the position written in
which is “Dược tá” (“pharmacist assistant”) or “Sơ cấp dược”.
Article 18.
Determination of scope of practice of holders of undefined qualifications and
positions
1. If a qualification issued by a
domestic training institution does not specify any of the positions specified
in Clause 1, 2, 7, 10 Article 17 hereof, the scope of practice shall be decided
by the issuer of the pharmacy practice certificate on the basis of counsel
provided by the certification advisory council.
2. Scope of practice of holders of
qualifications issued by overseas training institutions which have to be
certified according to regulations of the Minister of Transport shall be
determined in accordance with Clause 1 of this Article.
Section 4.
PHARMACY INTERNSHIP
Article 19.
Internship-offering establishments
1. Internship-offering
establishments are establishments specified in Clause 2 Article 13 of the Law
on Pharmacy, including: pharmacy business establishments, pharmacies of health
facilities, pharmacy training institutions, pharmacy research institutions,
laboratories testing drugs and medicinal materials, pharmacy authorities,
representative offices of foreign drug traders (hereinafter referred to as
“pharmacy establishment”); health facilities suitable for the interns’
qualifications.
2. An internship-offering
establishment is considered suitable is an establishment mentioned in Clause 1
of this Article and whose operation is suitable for the intern’s qualifications
according to Article 20 hereof.
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4.22 (repealed)
Article 20.
Internship contents
1. Pharmacists of manufacturers of
drugs, active ingredients, excipients and capsule shells:
a) The chief pharmacist of a drug
manufacturer, except for the cases in Point c and d of this Clause, shall
complete one of the following internship contents: drug manufacture, drug
testing, research and development of drug, pharmacy management at a pharmacy
authority;
b) The chief pharmacist of a
manufacturer of medicinal materials that are active ingredients, excipients and
capsule shells shall complete one of the following internship contents: drug
manufacture, drug testing, research and development of drug and medicinal
materials, manufacture of chemicals, pharmacy management at a pharmacy
authority;
c) The chief pharmacist of a
manufacturer of vaccines, biologicals and ingredients thereof shall complete
one of the following internship contents: manufacture of vaccines and
biologicals, testing of vaccines and biologicals, research and development of
vaccines and biologicals, pharmacy management at a pharmacy authority;
d) The chief pharmacist of a
traditional drug manufacturer shall complete one of the following internship
contents: manufacture and processing of traditional drugs, testing of
traditional drugs, quality assurance, research and development of traditional
drugs, traditional medicine or traditional pharmacy management at a pharmacy
authority.
2. Persons in charge of quality
assurance of manufacturers of drugs, active ingredients, excipients and capsule
shells:
a) The person in charge of quality
assurance of a drug manufacturer, except for the cases in Point c of this Clause,
shall complete one of the following internship contents: manufacture, testing,
quality assurance, research and development at a drug-manufacturing facility or
drug-testing of facility;
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c) The person in charge of quality
assurance of a manufacturer of vaccines and biologicals and ingredients thereof
shall complete one of the following internship contents: manufacture, testing,
quality assurance, research and development at a facility manufacturing or
testing vaccines and biologicals.
3. Pharmacists and persons in
charge of quality assurance of manufacturers of herbal materials
a) The pharmacist and the person in
charge of quality assurance of a manufacturer of herbal materials shall
complete one of the following internship contents: manufacture and processing
of herbal materials, traditional drugs and herbal drugs, testing of drugs,
quality assurance during the production of medicinal materials and traditional
drugs, traditional medicine or traditional pharmacy management at a pharmacy
authority;
b) The chief pharmacist and the
person in charge of quality assurance of a household business or cooperative
manufacturing herbal materials shall complete one of the following internship
contents: manufacture of medicinal materials, drug testing, quality assurance
during the production of herbal materials and traditional drugs, concoction of
traditional drugs, traditional medicine or traditional pharmacy management at a
pharmacy authority.
4. Pharmacists of wholesalers of
drugs and medicinal materials
a) The chief pharmacist of a drug
manufacturer, except for the cases in Point c and d of this Clause, shall
complete one of the following internship contents: drug manufacture, drug
testing, research and development of drug, pharmacy management at a pharmacy
authority;
b) The pharmacist of a wholesaler
of medicinal materials shall complete one of the following internship contents:
manufacture of medicinal materials and chemicals, testing of drugs and
medicinal materials, research into chemical and pharmaceutical technology;
wholesaling of drugs, export and import of drugs; storage of drugs and
medicinal materials; traditional pharmacy or traditional medicine management at
a pharmacy authority;
c) The chief pharmacist of a
wholesaler of vaccines and biologicals shall complete one of the following
internship contents: manufacture, wholesaling, storage, testing of vaccines and
biologicals, research into vaccines and biologicals, pharmacy management at a
pharmacy authority;
d) The chief pharmacist of a
wholesaler of herbal materials, herbal drugs and traditional drugs shall
complete one of the following internship contents: wholesaling of drugs and
herbal materials; storage of drugs and herbal materials, testing of drugs and
medicinal materials, traditional medicine; research into herbal materials and
traditional medicine; traditional pharmacy or traditional medicine management
at a pharmacy authority.
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a) The chief pharmacist of an
exporter of importer of drugs and medicinal materials, except for the cases in
Points b and c of this Clause, shall complete one of the following internship
contents: wholesaling of drugs, export and import of drugs; manufacture of
drugs; testing of drugs and medicinal materials; Good Storage Practice (GSP);
pharmacy management related to sale, export, import, wholesaling of drugs and
medicinal materials; pharmacy management at a pharmacy authority;
b) The chief pharmacist of an
exporter or importer of vaccines and biologicals shall complete one of the
following internship contents: manufacture, wholesaling, storage, testing of
vaccines and biologicals, research into vaccines and biologicals; use of
vaccines and biologicals; pharmacy management at a pharmacy authority;
c) The chief pharmacist of an
exporter or importer of herbal materials, herbal drugs and traditional drugs
shall complete one of the following internship contents: wholesaling of drugs
and medicinal materials; storage of drugs and medicinal materials; manufacture
of drugs and medicinal materials; testing of drugs, medicinal materials and
traditional medicine; research into herbal materials and traditional medicine; traditional
pharmacy or traditional medicine management at a pharmacy authority.
6. Pharmacists of drug retailers
a) The chief pharmacist of a
drugstore or dispensary of a commune shall complete one of the following
internship contents: wholesaling and retailing of drugs; export and import of
drugs; clinical pharmacology; supply of drugs for health facilities;
manufacture of drugs; testing of drugs and medicinal materials; pharmaceutical
research; drug storage; drug distribution; pharmacy management at a pharmacy
authority;
b) The chief pharmacist of a
retailer of herbal materials, herbal drugs and traditional drugs, except for
the cases in Point c Clause 2 Article 13 of the Law on Pharmacy, shall complete
one of the following internship contents: manufacture, research, sale,
traditional medicine; traditional pharmacy or traditional medicine management
at a pharmacy authority.
7. Pharmacists of providers of
drug/medicinal materials testing services
a) The chief pharmacist of a
provider of drug/medicinal materials testing services, except for the cases in
Point b of this Clause, shall complete one of the following internship
contents: testing of drugs and medicinal materials; research related to
manufacture, testing, analysis of drugs and medicinal materials; pharmacy
management at a pharmacy authority;
b) The chief pharmacist of a
provider of vaccine and biological testing services shall complete one of the
following internship contents: testing of drugs and medicinal materials;
testing of vaccines and biologicals; research related to manufacture and
testing of vaccines and biologicals; storage of vaccines and biologicals;
pharmacy management at a pharmacy authority.
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9. Persons in charge of clinical
pharmacology of medical facilities
a) The person in charge of clinical
pharmacology of a medical facility shall complete one of the following
internship contents: bioequivalence study; clinical trial; pharmacology and
clinical pharmacology research; pharmacovigilance at the drug information and
advert reaction monitoring center;
b) The person in charge of clinical
pharmacology of a traditional medicine facility shall complete one of the
following internship contents: clinical trial; pharmacology and clinical
pharmacology research; pharmacovigilance at the drug information and advert
reaction monitoring center.
10. Pharmacists of providers of
drug/medicinal materials storage services
a) The chief pharmacist shall
complete one of the following internship contents: Drug storage; pharmacy,
traditional pharmacy or traditional medicine management at a pharmacy
authority;
b) The chief pharmacist of a
provider of vaccine and biological storage services shall complete one of the
following internship contents: storage of vaccines and biologicals; manufacture
of vaccines and biologicals, testing of vaccines and biologicals; pharmacy
management at a pharmacy authority.
Article 21.
Internship durations of postgraduate degree holders
1. A postgraduate degree is either:
a) a Master’s degree in pharmacy,
medicine, traditional medicine, chemistry or biology;
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c) Specialized Level 1 (SL1) or
Specialized Level 2 (SL2) degree according to regulations of the Minister of
Health.
2.23 The specific internship durations at the pharmacy which
comply with the regulations in Articles 15, 16, 17, 18, 19, 20, 21 and 22 shall
be reduced for:
a. ¾ of the duration for holders of
PhDs or SL2 degrees in the field related to the specific internship;
b) ½ of the duration for holders of
Master Degrees or SL1 degrees in the field related to the specific internship.
Section 5.
EXAMINATIONS FOR THE PHARMACY PRACTICE CERTIFICATE
Article 22.
Examination methods and contents
1. The examination may be held at
an examination center or online.
2. Examination contents:
a) General pharmaceutical
knowledge;
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3. The Minister of Health shall
specify regulations, examination contents, question banks and grading scale.
Article 23.
Requirements to be satisfied by examination centers
1. The organization that
administers the examination for the pharmacy practice certificate (hereinafter
referred to as “examination center”) shall be an institution that provides
higher education training in pharmacy or traditional pharmacy.
2.24 (repealed)
Article 24.25 (repealed)
Article 25.26 (repealed)
Article 26.27 (repealed)
Article 27.28 (repealed)
Article 28.
Administering examination for the pharmacy practice certificate
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2. After 05 working days from the
day on which the examination results are available, the examination center
shall send notifications (Form No. 18 in Appendix I enclosed herewith) to the
candidates and send a list of passing candidates to the Ministry of Health.
3.30 The Ministry of Health shall assign the eligible
examination centers specified in Article 23 hereof to administer tests and
issue the Pharmacy Practice Certificate if there are no centers carrying out
such tasks.
Article 29.
Incentives for holders of pharmacy practice certificates after passing an
examination
A person who obtains the pharmacy
practice certificate after passing an examination will be eligible to certain
incentives when he/she applies to a public health organization. To be specific:
1. Priority during the employment
process if the examination result is excellent and the undergraduate or
postgraduate degree is an honours degree.
2. Exemption from internship after
being hired.
3. Priority in provision of
refresher training in Vietnam and overseas.
Article 30.
Examination fee
The candidates shall pay the
examination fees as prescribed by law.
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PHARMACY BUSINESS
Section 1.
CERTIFICATE OF ELIGIBILITY FOR PHARMACY BUSINESS
Article 31.
Eligibility for traditional drug business
1. A manufacturer of traditional
drugs that are sold nationwide shall meet the requirements in Clause 2a, 2c and
2d Article 69 of the Law on Pharmacy
2. The location, storage area, storage
equipment, vehicles, quality control system, documents about technologies and
personnel of an importer of traditional drugs shall meet GSP requirements
applied to traditional drugs. The chief pharmacist of the exporter or importer
of traditional drugs shall satisfy the requirements in Clause 3 Article 17 of
the Law on Pharmacy.
3. The location, storage area,
storage equipment, vehicles, quality control system, specialized documents and
personnel of a provider of traditional drug storage services shall meet GSP
requirements applied to traditional drugs. The chief pharmacist of the exporter
or importer of traditional drugs shall satisfy the requirements in Clause 1
Article 22 of the Law on Pharmacy.
4. The location, storage area,
storage equipment, vehicles, quality control system, specialized documents and
personnel of a wholesaler of traditional drugs shall meet Good Distribution
Practice (GDP) requirements applied to traditional drugs. The chief pharmacist
of the wholesaler of traditional drugs shall satisfy the requirements in Clause
3 Article 16 of the Law on Pharmacy.
5. Requirements to be satisfied by
retailers of herbal materials, herbal drugs and traditional drugs:
a) The chief pharmacist of the
retailer of herbal materials, herbal drugs or traditional drugs shall satisfy
the requirements in Clause 4 Article 18 of the Law on Pharmacy;
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c)32 The storage area and equipment must satisfy the storage
requirements written on the labels.
Toxic herbal materials (if any)
shall be displayed and stored in a separate area. Otherwise, they must be
separated from other herbal materials and labeled as “dược liệu độc” (“toxic
herbal materials”) to avoid confusion.
The retailer of herbal drugs,
traditional drugs or herbal materials shall have suitable storage areas to
store such drugs and materials or to store herbal materials and prepared
traditional medicinal materials.
d) Instruments and packages in
physical contact with herbal drugs, herbal materials or traditional drugs must
not affect their quality;
dd) Information about purchases,
sales and origins of drugs must be properly recorded;
e) The person who retails herbal
materials, herbal drugs or traditional drugs (the shopkeeper) shall have one of
the documents specified in Points a, c, e, g, i or l Clause 1 Article 13 of the
Law on Pharmacy.
Regarding toxic herbal materials
and prescription herbal drugs, the shopkeeper, who directly sells and counsel
buyers, must be a pharmacist;
g) Other goods (if any) must be
displayed and stored in a separate area and must not affect the herbal
materials, herbal drugs or traditional drugs.
Article 32.
Applications for issuance, reissuance and adjustment of the Certificate of
eligibility for pharmacy business
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1. Form No. 19, 20 or 21 in
Appendix I enclosed herewith for issuance, reissuance or adjustment of the
Certificate of eligibility for pharmacy business respectively;
2. Technical documents specified in
Clause 1b and Clause 2b Article 38 of the Law on Pharmacy, including the
Certificate of eligibility for pharmacy business or Certificate of Good
Practice at the business location (if any) and the following documents:
a)33 If the applicant is a manufacturer of drugs or medicinal
materials: documents about the location, factory, testing laboratory, storage
area, auxiliary systems, machinery for manufacturing and storing drugs, quality
control system, documents about technologies and personnel according to Good
Manufacturing Practice (GMP) requirements for drugs and medicinal materials.
If the applicant applies for a
Certificate of Eligibility for Pharmacy Business that allows sale and delivery
of drugs or medicinal materials manufactured by the applicant to wholesalers,
retailers and health facilities, documents on technologies and personnel
according to GDP for drugs and medicinal materials are required, unless such
products are delivered at the storage facility of the applicant.
b) If the applicant is an importer
or exporter of drugs or medicinal materials or a provider of drug or medicinal
material storage services, documents about the location, storage area, storage
equipment, vehicles, quality control system, documents about technologies and
personnel according to GSP for drugs and medicinal materials34.
c) If the applicant is a wholesaler
of drugs or medicinal materials, documents about the location, storage area,
storage equipment, vehicles, quality control system, documents about
technologies and personnel according to GDP for drugs and medicinal materials;
d) If the applicant is a drug
retailer, documents about the location, storage area, storage equipment,
vehicles, quality control system, documents about technologies and personnel
according to Good Pharmacy Practice (GPP) requirements.
If the applicant is a retailer of
herbal materials, herbal drugs or traditional drugs, documents proving fulfillment
of the requirements in Clause 5 Article 31 hereof according to regulations of
the Minister of Health;
dd) If the applicant is a provider
of drug or medicinal material testing services, documents about the location,
testing laboratory, auxiliary system, testing equipment, chemicals, reagents,
quality control system, documents about technology and personnel according to
Good Laboratory Practice (GLP) requirements;
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g) If the applicant is a provider
of bioequivalence study services, documents about the location, the laboratory
for biological fluid analysis, equipment for biological fluid analysis, the
area for monitoring drug users serving bioequivalence study, the quality
control system, documents about technology and personnel according to GLP
requirements for the biological fluid analysis and GCP requirements for the
clinical study.
In the cases where the provider of
bioequivalence study services signs a contract or cooperate with a clinical
trial service provider that meets GCP requirements in carrying out the clinical
trial, the technical file may not include documents on the location, laboratory
for biofluid analysis, testing equipment for biofluid analysis, accommodations
and monitoring of drug users to serve the assessment of bioequivalence, quality
management system, professional and technical documents and personnel according
to GCP requirements.
3.35 (repealed)
Article 33.
Procedures for issuance of the Certificate of eligibility for pharmacy business
1. The applicant shall submit an
application, directly or by post, to:
a) the Ministry of Health in any of
the cases mentioned in Point a, b, c, e, g, h Clause 2 Article 32 of the Law on
Pharmacy;
b) the Department of Health of the
province where the applicant's business location36 exists in any of the cases mentioned in Point d and dd
Clause 2 Article 32 of the Law on Pharmacy;
2. After receiving the application,
the receiving authority shall give the applicant form No. 01 in Appendix I
enclosed herewith.
3.37 The receiving authority shall:
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b) carry out a site inspection at
the applicant’s premises within 20 days from the day on which the application
is received.
4.39 If the application is deemed unsatisfactory
according to Clause 3a of this Article, within 07 working days from the date of
receipt, the receiving authority shall request the applicant in writing to
complete the application and specify necessary additional documents.
If the application is not
satisfactory, within 10 working days from the date of receipt, the receiving
authority shall request the applicant in writing to complete the application
and specify necessary additional documents.
5. After receiving the supplemented
application, the receiving authority shall give the applicant form No. 01 in
Appendix I enclosed herewith.
a) If the supplemented application
is still unsatisfactory, the Ministry of Health shall request the applicant to
complete it in accordance with Clause 4 of this Article;
b) If the supplemented application
is satisfactory, the receiving authority shall follow the instructions in
Clause 3 of this Article.
6. After the site inspection is
done, the receiving authority shall:
a) issue the Certificate of
eligibility for pharmacy business within 10 working days from the day on which
the site inspection is done and no remedial actions are requested;
b) issue a notification of
necessary remedial actions (if any) within 05 working days.
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8. Within 06 months from the day on
which additional documents are requested in writing by the receiving authority,
the applicant shall submit additional documents as requested. If the applicant
fails to satisfy such request by the aforementioned deadline or the application
is not satisfactory within 12 months from the first time it is submitted, the
application will be rejected.
9. Within 05 working days from the
date of issuance of the Certificate of eligibility for pharmacy business, the
receiving authority shall update the following information on its website:
a) The name and address of the
holder of the Certificate of eligibility for pharmacy business;
b) Full name of the chief
pharmacist and his/her pharmacy practice certificate number;
c) Number of the Certificate of
eligibility for pharmacy business.
10. In the case specified in Clause
1b Article 36 of the Law on Pharmacy, the applicant shall return the old
certificate, unless it is lost.
11. The Certificate of eligibility
for pharmacy business shall be made into 02 copies according to Form No. 22 in
Appendix I enclosed herewith. 01 copy will be given to the applicant while the
other retained by the issuing authority.
12. If the applicant has met Good
Practice requirements, the authority that issues the Certificate of eligibility
for pharmacy business shall issue the Certificate of Good Practice.
Article 34.
Procedures for reissuing and adjusting the Certificate of eligibility for
pharmacy business
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a) the Ministry of Health in any of
the cases mentioned in Point a, b, c, e, g, h Clause 2 Article 32 of the Law on
Pharmacy;
b) the Department of Health of the
province where the applicant's business location40 exists in any of the cases mentioned in Point d and dd
Clause 2 Article 32 of the Law on Pharmacy;
2. After receiving the application,
the receiving authority shall give the applicant form No. 01 in Appendix I
enclosed herewith.
3. If the application is
satisfactory, the receiving authority shall:
a)41 re-issue or adjust the Certificate of Eligibility for
Pharmacy Business within 15 days from the date of receipt, in the case
mentioned in Clause 2a and Clause 3, Article 36 of the Law on Pharmacy;
b) reissue or adjust the
Certificate of eligibility for pharmacy business within 07 working days from
the date of receipt in the case mentioned in Clause 2b Article 36 of the Law on
Pharmacy.
4. If the application is not
satisfactory, within 05 working days from the date of receipt, the receiving
authority shall request the applicant in writing to complete the application
and specify necessary additional documents.
5. After receiving the supplemented
application, the receiving authority shall give the applicant form No. 01 in
Appendix I enclosed herewith.
a) If the supplemented application
is still unsatisfactory, the Ministry of Health shall request the applicant to
complete it in accordance with Clause 4 of this Article;
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6. Within 06 months from the day on
which additional documents are requested in writing by the receiving authority,
the applicant shall submit additional documents as requested. If the applicant
fails to satisfy such request by the aforementioned deadline or the application
is not satisfactory within 12 months from the first time it is submitted, the
application will be rejected.
7. Within 05 working days from the
day on which the Certificate of eligibility for pharmacy business is reissued
or adjusted, the receiving authority shall update the following information on
its website:
a) The name and address of the
holder of the Certificate of eligibility for pharmacy business that is reissued
or adjusted;
b) Full name of the chief
pharmacist and his/her pharmacy practice certificate number;
c) Number of the Certificate of
eligibility for pharmacy business.
8. After receiving the new
Certificate of eligibility for pharmacy business, the applicant shall return
the old one unless it has been lost.
9. The Certificate of eligibility
for pharmacy business shall be made into 02 copies according to Form No. 22 in
Appendix I enclosed herewith. 01 copy will be given to the applicant while the
other retained by the issuing authority.
Article 35.
Procedures for revocation of the Certificate of eligibility for pharmacy
business
1. Within 05 working days from the
day on which the proposal to revoke the Certificate of eligibility for pharmacy
business is received or from the discovery of the cases mentioned in Article 40
of the Law on Pharmacy, the issuing authority shall revoke the Certificate of
eligibility for pharmacy business it issued, or respond the proposing authority
and provide explanation in writing if such proposal is rejected;
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a) Post such decision on its
website and send it to the Ministry of Health and Departments of Health nationwide;
b) Update information about
revocation on its website.
3. Within 05 working days from the
day on which the decision to revoke the Certificate of eligibility for pharmacy
business is received, the Ministry of Health and the Departments of Health mentioned
shall post it on their websites.
Article 2.
SCOPE OF OPERATION OF RETAILING DISPENSARIES AND DRUG COUNTERS
Article 36.
Locations of retailing dispensaries and drug counters
1. Locations of retailing
dispensaries
a) Retailing dispensaries may be
opened in communes and small towns;
b) If the ratio of dispensary to
2,000 people in ward that has just been converted from a commune or small town
is smaller than 1, new retailing dispensaries may be opened for up to 03 years
from the conversion date.
c) A retailing dispensary which is
opened in an area other than those mentioned in Clause 1a of this Article and
already granted a certificate of eligibility for drug business before the
effective date of this Decree may operate until the expiration date of the certificate.
If the certificate of eligibility for drug business does not have an expiration
date, it may operate for up to 03 more years from the effective date of this
Decree.
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a) In medical stations of communes;
b) In medical stations of communes
in ethnic areas, mountainous areas, islands, extremely disadvantaged areas.
Article 37.
Scope of operation of retailing dispensaries and drug counters
1. The scope of operation of a
retailing dispensary is specified in Clause 1b Article 48 of the Law on
Pharmacy.
2. The scope of operation of a drug
counter is specified in Clause 1b Article 49 of the Law on Pharmacy.
Section 3.
MOBILE DRUGSTORES
Article 38.
Requirements for operating a mobile drugstore
1. The following entities may operate
a mobile drugstore:
a) Drug manufacturers;
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c) Drug retailers;
d) Medical facilities of the
military that supply drugs in ethnic areas, mountainous areas, islands,
extremely disadvantaged areas.
2. The keeper of the mobile drugstore
must be an employee of the mobile drugstore owner mentioned in Clause 1 of this
Article and has one of the qualifications mentioned in Points a, b, c, e, g, h,
i and k Clause 1 Article 13 of the Law on Pharmacy.
3. Drugs sold by a mobile drugstore
must not expire for the next 06 months, be stored with hygienic equipment and
protected from the weather.
4. Each mobile drugstore must have
a signboard which specifies its owner, full name of the keeper and the
operating area.
5. 42 (repealed)
Article 39.
List of drugs and area for mobile drugstore operation
1. A drug sold by a mobile
drugstore shall satisfy the following criteria:
a) It is on the list of OTC drugs;
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c) It is meant to serve common
purposes of local people.
2. Pursuant to Clause 1 of this
Article, the Director of the Department of Health shall publish a list of drugs
and areas permissible for mobile drugstores.
Article 40.
Procedures for registration of a mobile drugstore
1. The applicant for registration
of a mobile drugstore shall submit Form No. 23 in Appendix I enclosed herewith
to the Department of Health of the province where the mobile drugstore
operates.
2.43 (repealed)
3.44 Within 05 working days from the date on which the
notification from the applicant is received, the Department of Health shall
publish information about the mobile drugstore on its website and inform the
district health offices for supervision and inspection.
Section 4.
MEASURES AGAINST LOSS OF CONTROLLED DRUGS AND MEDICINAL MATERIALS; PROCEDURES
FOR GRANTING PERMISSION FOR TRADING IN CONTROLLED DRUGS AND DRUGS RESTRICTED
FROM RETAILING
Article 41.
List of radioactive substances permissible for health facilities and issuance
of list of drugs and active ingredients banned from certain fields
1. The list of radioactive
substances permissible for health facilities is promulgated in Appendix IV
enclosed herewith.
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a) Ministries and ministerial
agencies shall send the Ministry of Health their lists of banned substances in
their fields or amendments thereto;
b)46 After receiving the list of banned substances from the
ministries and ministerial agencies, the Ministry of Health shall promulgate
the list of banned drugs and active ingredients in certain fields on its
website.
Article 42.
Eligibility for trading in controlled drugs
1. To be allowed to trade in
controlled drugs, an establishment shall:
a) satisfy the requirements in
Article 33 of the Law on Pharmacy applicable to its type of business;
b) comply with regulations on
security measures in Articles 43, 44, 45, 46, 47 and 48 hereof.
c) comply with the Law on Atomic
Energy and relevant legislative documents in addition to the conditions
specified in Clause 1a and 1b of this Article if trading in
radiopharmaceuticals.
2.47 If there are no establishments trading controlled drugs
in the province, the Department of Health shall appoint a wholesaler or a
retailer to conduct such trading or the pharmacy department of the health
facility to sell the controlled drugs in order to ensure adequate supply of
drugs for patients.
3. The Ministry of Health and
Departments of Health shall carry out an inspection every 03 years or on an ad
hoc basis to ensure implementation of security measures in Section 4 Chapter
III at establishments trading in controlled drugs in accordance with
regulations of the Minister of Health or international treaties to which
Vietnam is a signatory.
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1. A manufacturer of narcotic
drugs, psychotropic drugs, precursor drugs, medicinal materials that are
narcotic active ingredients, psychotropic active ingredients or drug precursors
shall:
a) Have a separate storage facility
or area that meets GSP requirements. Such separate storage facility or area must
have robust doors with locks48 to
store narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials
that are narcotic active ingredients, psychotropic active ingredients or drug
precursors.
b) have a camera system to monitor
each and every stage of the manufacture and storage process;
c) have a documentary management
system according to regulations of the Minister of Health.
d)49 (repealed)
2. A manufacturer of combination
drugs that contain narcotic active ingredients, combination drugs that contain
psychotropic active ingredients and combination drugs that contain precursors
shall:
a) Have a separate storage facility
or area that meets GSP requirements. Such separate storage facility or area
must have robust doors with locks50
to store the narcotic drugs, psychotropic drugs, precursor drugs, medicinal
materials that are narcotic active ingredients, psychotropic active ingredients
or drug precursors.
b) Have a separate area to store combination
drugs that contain narcotic active ingredients, combination drugs that contain
psychotropic active ingredients and combination drugs that contain precursors;
c) Have a camera system to monitor
each and every stage of the manufacture and storage process;
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dd)51 (repealed)
3. A manufacturer of
radiopharmaceuticals shall:
a) Have a separate storage area
that meets GSP requirements to store the radiopharmaceuticals;
b)52 (repealed)
c)53 (repealed)
d) Have a documentary management
system according to regulations of the Minister of Health;
dd) Have a camera system in the
manufacture and storage area.
4. An exporter, importer of
narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that
are narcotic active ingredients, psychotropic active ingredients or drug
precursors or provider of storage services for these drugs shall:
a)54 Have a separate storage facility or area that
meets GSP requirements. Such separate storage facility or area must have robust
doors with locks to store narcotic drugs, psychotropic drugs, precursor drugs,
medicinal materials that are narcotic active ingredients, psychotropic active
ingredients or drug precursors.
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c) Have a documentary management
system according to regulations of the Minister of Health.
d)55 (repealed)
5. An exporter, importer or
wholesaler of combination drugs that contain narcotic active ingredients, combination
drugs that contain psychotropic active ingredients or combination drugs that
contain precursors or a provider of storage services for these drugs shall:
b) Have a separate storage facility
or area that meets GSP requirements. Such separate storage facility or area
must have robust doors with locks56 to
store combination drugs that contain narcotic active ingredients, combination
drugs that contain psychotropic active ingredients and combination drugs that
contain precursors; have a documentary management system according to
regulations of the Minister of Health.
c) 57 (repealed)
6.58 An exporter, importer or wholesaler of
radiopharmaceuticals shall have a documentary management system according to
the regulations of the Minister of Health.
7. A wholesaler of narcotic drugs,
psychotropic drugs or precursor drugs shall:
a) Have a separate storage facility
or area that meets GSP requirements. Such separate storage facility or area
must have robust doors with locks59
to store narcotic drugs, psychotropic drugs or precursor drugs;
b) Have a camera system in the
storage area;
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d) 60 (repealed)
8. A retailer of narcotic drugs,
psychotropic drugs or precursor drugs shall:
a)61 The narcotic drugs, psychotropic drugs or precursor drugs
must be stored in a separate and locked cabinet or drawer;
b) Have a documentary management
system according to regulations of the Minister of Health.
9. A retailer of combination drugs
that contain narcotic active ingredients, combination drugs that contain
psychotropic active ingredients or combination drugs that contain precursors
shall have a software system and documentary management system for monitoring
and managing the inventory of these drugs according to regulations of the
Minister of Health
10. A retailer of
radiopharmaceuticals shall:
a) Have a separate area to store
radiopharmaceuticals;
b)62 (repealed)
c) Have a documentary management
system according to regulations of the Minister of Health.
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11. A provider of clinical study
services, bioequivalence study services, testing services or storage services
for radiopharmaceuticals:
a) have a separate storage area
that meets GSP requirements to store the radiopharmaceuticals; have a
documentary management system according to regulations of the Minister of
Health; A provider of radiopharmaceutical storage services shall have a camera
system;
b)64 (repealed)
c)65 (repealed)
d) Have a documentary management
system according to regulations of the Minister of Health;
dd) A provider of radiopharmaceutical
storage services shall have a camera system.
12.66 A provider of clinical trial services, bioequivalence
study services, controlled drug testing services, except for those mentioned in
Clause 11 of this Article, shall store the narcotic drugs, psychotropic drugs,
precursor drugs, medicinal materials that are narcotic active ingredients,
psychotropic active ingredients or drug precursors, combination drugs that
contain narcotic active ingredients, combination drugs that contain psychotropic
active ingredients or combination drugs that contain precursors in a separate
and locked area or separate and locked cabinets or drawers.
13. A trader of toxic drugs, toxic
medicinal materials, drugs or active ingredients on the list of banned substances
in certain fields shall have a software system or documentary management system
to manage its inventory according to regulations of the Minister of Health.
Article 44.
Personnel of traders of controlled drugs
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a) The warehouse-keeper responsible
for narcotic drugs, medicinal materials that are narcotic active ingredients
shall have at least a bachelor’s degree in pharmacy and had an internship at a
pharmacy business establishment that lasted at least 12 months67;
b) The warehouse-keeper responsible
for psychotropic drugs, precursor drugs, medicinal materials that are
psychotropic active ingredients or drug precursors shall have at least an
associate degree in pharmacy and had an internship at a pharmacy business
establishment that lasted at least 12 months68;
c)69 (repealed)
2. Personnel of a manufacturer of combination
drugs that contain narcotic active ingredients, combination drugs that contain
psychotropic active ingredients or combination drugs that contain precursors:
a) The warehouse-keeper responsible
for medicinal materials that are narcotic active ingredients shall have at
least a bachelor’s degree in pharmacy and had an internship at a pharmacy
business establishment that lasted at least 12 months70;
b) The warehouse-keeper responsible
for medicinal materials that are psychotropic active ingredients or drug
precursors shall have at least an associate degree in pharmacy and had an
internship at a pharmacy business establishment that lasted at least 12 months71;
c)72 (repealed)
3. Personnel of a manufacturer of
radiopharmaceuticals:
a) The warehouse-keeper shall have
at least an associate degree in pharmacy or a bachelor’s degree in
radiochemistry, radiology or nuclear medicine.
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c) The supervisor of research,
manufacture, analysis, testing processes shall have at least a bachelor’s
degree in radiochemistry, radiology, nuclear medicine or pharmacy.
4. Personnel of an exporter or
importer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal
materials that are narcotic active ingredients, psychotropic active ingredients
or drug precursors:
a) The warehouse-keeper responsible
for narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials
that are narcotic active ingredients, psychotropic active ingredients or drug
precursors shall have at least a bachelor’s degree in pharmacy and had an
internship at a pharmacy business establishment that lasted at least 12 months74.
b)75 (repealed)
5. 76 (repealed)
6. Personnel of a wholesaler of
narcotic drugs, psychotropic drugs or precursor drugs:
a) The warehouse-keeper responsible
for narcotic drugs shall have at least a bachelor’s degree in pharmacy and had
an internship at a pharmacy business establishment that lasted at least 12
months77;
b) The warehouse-keeper responsible
for psychotropic drugs or precursor drugs shall have at least an associate
degree in pharmacy and had an internship at a pharmacy business establishment
that lasted at least 12 months78.
c)79 (repealed)
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8. Personnel of a retailer of
narcotic drugs, psychotropic drugs or precursor drugs:
a) The shopkeeper that sells
narcotic drugs shall have at least a bachelor’s degree in pharmacy;
b) The shopkeeper that sells
psychotropic drugs or precursor drugs shall have at least an associate degree
in pharmacy.
9.81 As for the retailer of radiopharmaceuticals: the person
responsible for retailing such drugs must have at least an associate degree in
pharmacy.
10. The warehouse-keeper
responsible for narcotic drugs, psychotropic drugs, precursor drugs, medicinal
materials that are narcotic active ingredients, psychotropic active ingredients
or drug precursors of a drug storage service provider shall have at least a
bachelor’s degree in pharmacy and had an internship at a pharmacy business
establishment that lasted at least 12 months82
11. Personnel of a provider of
clinical trial services, bioequivalence study services, testing services that
involve narcotic drugs, psychotropic drugs, precursor drugs, medicinal
materials that are narcotic active ingredients, psychotropic active ingredients
or drug precursors: the manager of drugs, psychotropic drugs, precursor
drugs, medicinal materials that are narcotic active ingredients, psychotropic
active ingredients or drug precursors shall have at least an associate degree
in pharmacy.
12. Personnel of a provider of
clinical trial services, bioequivalence study services, testing services that
involve radiopharmaceuticals:
a) The warehouse-keeper shall have
at least an associate degree in pharmacy or a bachelor’s degree in
radiochemistry, radiology or nuclear medicine; The supervisor of research,
manufacture, analysis, testing processes shall have at least a bachelor’s
degree in radiochemistry, radiology, nuclear medicine or pharmacy;
b)83 (repealed)
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Article 45.
Delivery of controlled drugs
1. The deliverer and recipient of
controlled drugs or medicinal materials shall have at least an associate degree
in pharmacy; the deliverer and recipient of radiopharmaceuticals shall have a
certificate of training in radiation safety according to regulations of the
Ministry of Science and Technology in addition to the associate degree in
pharmacy.
2. The deliverer of narcotic drugs,
psychotropic drugs, precursor drugs, medicinal materials that are narcotic
active ingredients, psychotropic active ingredients, drug precursors shall
bring the head’s assignment letter, identification paper, and the sale invoice
or receipt. In case of delivery of radiopharmaceuticals, the deliverer shall bring
the certificate of training in radiation safety in addition to the
aforementioned documents.
3. Upon delivery of narcotic drugs,
psychotropic drugs, precursor drugs, medicinal materials that are narcotic
active ingredients, psychotropic active ingredients or drug precursors, a
delivery note shall be made according to Form No. 01 in Appendix II enclosed
herewith.
4. The transport of medicinal
materials that are narcotic active ingredients, psychotropic active ingredients
or drug precursors, narcotic drugs, active ingredients and precursors must
ensure security and prevent leakage. The transport of radiopharmaceuticals
shall ensure radiation safety in accordance with regulations on safe transport
of radioactive materials promulgated by the Minister of Science and Technology.
5. Each establishment participating
in the delivery of the radiopharmaceuticals shall have the license to perform
radiological works that allows transport of radiation sources as prescribed by
the Ministry of Science and Technology.
Article 46.
Trading in controlled drugs
1. Regarding medicinal materials
that are narcotic active ingredients, psychotropic active ingredients or drug
precursors:
a) A manufacture may only import
ingredients serving the manufacture of its drugs;
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c) When a drug manufacturer wishes
to sell its redundant materials to another manufacturer or importer eligible to
trade in controlled drugs, it must obtain a written permission from the
Ministry of Health.
2. Regarding narcotic drugs,
psychotropic drugs, precursor drugs and combination drugs that contain
precursors:
a) A manufacturer may only sell
drugs it manufactures to establishments that have the Certificate of
eligibility for pharmacy business that allows export, import and wholesaling of
drugs, health facilities, research and testing establishments, rehabilitation
centers, establishments providing opioid substitution treatment, establishments
providing training in medicine or pharmacy nationwide; and may select 01
wholesaler in a province to sell all of its products;
b) An importer may only sell drugs
it imports to establishments that have the Certificate of eligibility for
pharmacy business that allows export, import and wholesaling of drugs, health
facilities, research and testing establishments, rehabilitation centers,
establishments providing opioid substitution treatment, establishments
providing training in medicine or pharmacy nationwide; and may select 01
wholesaler in a province to sell all of the products it imports;
c)84 An establishment that has the Certificate of Eligibility
for Pharmacy Business that allows export, import and wholesaling of drugs may
only sell drugs to other establishments that have such Certificates, health
facilities, research and testing establishments, rehabilitation centers,
establishments providing opioid substitution treatment, establishments
providing training in medicine or pharmacy, drugstores nationwide; and may
select 01 wholesaler in a province to sell all of its products;
d)85 A wholesaler may only sell drugs to health facilities,
research and testing establishments, rehabilitation centers, establishments
providing opioid substitution treatment, institutions providing training in
medicine or pharmacy, other non-commercial pharmacy establishments and
drugstores in the same province.;
dd)86 Health facilities, rehabilitation centers and
establishments providing opioid substitution treatment may purchase drugs from
the establishments specified in Points a, b, c, d of this Clause based on their
bidding results or according to the bidding plan approved by the competent
person. Private health facilities may purchase drugs from the establishments
specified in Points a, b, c, d of this Clause based on the prescriptions
approved by the competent authority.
3. Combination drugs that contain
narcotic active ingredients or combination drugs that contain psychotropic
active ingredients, radiopharmaceuticals, toxic drugs, toxic medicinal
materials, drugs and active ingredients on the list of banned substances in
certain fields may be traded in accordance with Chapter IV of the Law on
Pharmacy.
Article 47.
Reporting by traders of controlled drugs
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a) Each exporter and importer of
narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that
are narcotic active ingredients, psychotropic active ingredients or drug
precursors shall prepare a report on the export or import within 10 days from
the date of export or import according to Form No. 02 and Form No. 03 in
Appendix II enclosed herewith and send it to the Ministry of Health and the
Ministry of Public Security;
b) Each exporter and importer of
radiopharmaceuticals shall prepare a report on the export or import according
to Form No. 04 and Form No. 05 in Appendix II enclosed herewith and send it to
the Ministry of Health within 10 days from the date of export or import;
c) By the 15th of
January of the succeeding year, each exporter and importer of combination drugs
that contain narcotic active ingredients, combination drugs that contain
psychotropic active ingredients, combination drugs that contain precursors or
radiopharmaceuticals shall prepare the annual report on export or import of
these drugs according to Forms No. 06, 07, 08 in Appendix II enclosed herewith
and send it to the Ministry of Health.
2. By the 15th of July
and 15th of January, each manufacturer, exporter and importer of
narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that
are narcotic active ingredients, psychotropic active ingredients or drug
precursors shall prepare a biannual report and an annual report according to
Form No. 09 and 10 in Appendix II enclosed herewith and send them to the
Ministry of Health.
3. By the 15th of July
and 15th of January, each manufacturer, exporter and importer of
radiopharmaceuticals, combination drugs that contain narcotic active
ingredients, combination drugs that contain psychotropic active ingredients and
combination drugs that contain precursors shall prepare a biannual report and
an annual report according to Form No. 11 and 12 in Appendix II enclosed
herewith and send them to the Ministry of Health.
4. By the 15th of July and
15th of January, each wholesaler and retailer of
radiopharmaceuticals, narcotic drugs, psychotropic drugs, precursor drugs, combination
drugs that contain narcotic active ingredients, combination drugs that contain
psychotropic active ingredients and combination drugs that contain precursors
shall prepare a biannual report and an annual report according to Form No. 11,
12, 13 in Appendix II enclosed herewith and send them to the Department of
Health of the province where their headquarters are situated.
5.. By the 15th of
January, each manufacturer and exporter of drugs or active ingredients on the
list of drugs and active ingredients banned from certain fields shall prepare
and send a report according to Form No. 09 in Appendix II to the Ministry of
Health. Each wholesaler of drugs or active ingredients on the list of drugs and
active ingredients banned from certain fields shall prepare a report according
to Form No. 09 in Appendix II and send it to the Department of Health of the
same province.
6. Within 48 hours from discovery
of a mistake, loss of radiopharmaceuticals, narcotic drugs, psychotropic drugs,
precursor drugs or medicinal materials that are active ingredients,
psychotropic active ingredients or drug precursors, the manufacturer, exporter,
importer, drug storage service provider, clinical trial service provider,
bioequivalence study service provider or drug testing service provider shall
prepare a written report and send it to the Ministry of Health; the wholesaler
or retailer shall submit a report to Department of Health according to Form No.
14 in Appendix II enclosed herewith.
7. By the 15th January,
the Department of Health of each province shall submit a list of wholesalers of
narcotic drugs, psychotropic drugs, precursor drugs and combination drugs that
contain precursors in their provinces according to Form No. 15 in Appendix II
enclosed herewith to the Ministry of Health.
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1. The applicant for permission to
destroy narcotic drugs, psychotropic drugs, precursor drugs, medicinal
materials that are narcotic active ingredients, psychotropic active ingredients
or drug precursors shall submit an application form which specifies the name of
the drug or medicinal material, concentration, quantity, reason for destruction
and destruction method.
2. Procedures for granting
permission for destruction of narcotic drugs, psychotropic drugs, precursor
drugs, medicinal materials that are narcotic active ingredients, psychotropic
active ingredients or drug precursors:
a)87 The application shall be sent in person or by post to the
Ministry of Health if the applicant is a manufacturer, exporter or importer, or
to the Department of Health of the same province if the applicant is a pharmacy
business establishment other than the aforesaid entities; or at the Military
Medicine Department (Ministry of National Defense) if the applicant is under
the management of such Ministry;
b) After receiving the application,
the receiving authority shall give the applicant form No. 01 in Appendix I
enclosed herewith;
c)88 If the application is satisfactory, the receiving
authority shall issue a written permission for destruction within 20 days from
the date on which the application is received;
d)89 If the application is not satisfactory, the receiving
authority shall request the applicant in writing to complete the application
within 20 days from the date on which the application is received;
dd) After receiving the
supplemented application, the receiving authority shall give the applicant form
No. 01 in Appendix I enclosed herewith. If the supplemented application is
satisfactory, the receiving authority shall issue a written permission in
accordance with Point c of this Clause. If the supplemented application is
still unsatisfactory, the receiving authority shall request the applicant to
complete it in accordance with Point d of this Clause.
3.90 The destruction of narcotic drugs, psychotropic drugs,
precursor drugs or medicinal materials that are narcotic active ingredients,
psychotropic active ingredients or drug precursors may only be carried out
after receiving the written permission from the Ministry of Health or the
Department of Health in the same province, or from the Military Medicine
Department (Ministry of National Defense).
4. Procedures for destruction of
narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that
are narcotic active ingredients, psychotropic active ingredients or drug
precursors:
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b)91 The destruction must be witnessed by representatives of
the Department of Health of the same province or the Military Medicine
Department (Ministry of National Defense) and be recorded using form No. 16 in
Appendix II hereto;
c) 92 Within 10 days from the date on which the destruction is
done, a destruction report (using form No. 17 in Appendix II) enclosed with a
destruction record shall be submitted to the Ministry of Health or Department
of Health or Military Medicine Department (Ministry of National Defense).
5. Unused radiopharmaceuticals and
primary packages of radiopharmaceuticals shall be stored properly before destruction
in accordance with regulations of law on atomic energy.
6. Unused radiopharmaceuticals and
primary packages of radiopharmaceuticals shall be stored properly before
destruction in accordance with regulations of law on atomic energy.
7. When destroying redundant
products or wastes that contain narcotic active ingredients, psychotropic
active ingredients or drug precursors; combination drugs that contain narcotic
active ingredients, combination drugs that contain psychotropic active
ingredients and combination drugs that contain precursors, primary packages of
narcotic drugs, psychotropic drugs, precursor drugs, narcotic active
ingredients, psychotropic active ingredients, drug precursors, toxic drugs,
toxic medicinal materials, drugs and active ingredients on the list of drugs
and active ingredients banned in certain fields, the owner shall gather and
destroy them in accordance with Clause 4a of this Article and retain documents
about the destruction.
Article 49.
Composition of the application for permission to trade in controlled drugs
An establishment that wishes to
trade in controlled drugs shall submit the following documents in addition to
the documents specified in Article 32 hereof:
1.93 Documents proving that the establishment has taken
measures to ensure security and prevent loss of controlled drugs according to
Form No. 18 in Appendix II hereto
2.94 (repealed)
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4. Only 01 set of documents
specified in this Article is required.
Article 50.95 (repealed)
Article 51.
Procedures for issuance of the Certificate of Eligibility for Pharmacy Business
to traders of controlled drugs96
1. The procedures for issuance of
the Certificate of Eligibility for Pharmacy Business to the traders of
controlled drugs shall be completed in accordance with Article 33 hereof.
2. If the trader already has such
Certificate or satisfies the Good Practice requirements according to Article 33
of the Law on Pharmacy and requests for the permission for trading controlled
drugs, the receiving authority shall only evaluate the application mentioned in
Article 49 of the Decree No. 54/2017/ND-CP .
Article 52.97 (repealed)
Article 53.
Composition of the application for permission to purchase narcotic drugs,
psychotropic drugs, precursor drugs or medicinal materials that are narcotic
active ingredients, psychotropic active ingredients or drug precursors;
composition of the application for permission to sell medicinal materials that
are narcotic active ingredients, psychotropic active ingredients or drug
precursors
1. An application for permission to
purchase narcotic drugs, psychotropic drugs or precursor drugs consists of:
a) 03 copies of the order for
narcotic drugs, psychotropic drugs or precursor drugs according to Form No. 19
in Appendix II enclosed herewith;
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c) A written explanation for
purchasing a quantity of drugs that exceeds the previous purchase by over 150%.
2. An application for permission to
purchase medicinal materials that are narcotic active ingredients, psychotropic
active ingredients or drug precursors consists of:
a)99 01 copy of the order for medicinal materials that contain
narcotic active ingredients, psychotropic active ingredients or drug precursors
using form No. 19 in Appendix II hereto;
b) A report on use of medicinal
materials according to Form No. 10 in Appendix II enclosed herewith;
c) The report on sales of medicinal
materials that are narcotic active ingredients, psychotropic active ingredients
or drug precursors according to Form No. 20 in Appendix II enclosed herewith;
d) A plan for manufacture of drugs
from the materials to be purchased;
dd) A written explanation for
purchasing a quantity of medicinal materials that exceed the previous purchase
by over 150%.
3. An application for permission to
sell medicinal materials that are narcotic active ingredients, psychotropic
active ingredients or drug precursors consists of:
a) Form No. 21 in Appendix II
enclosed herewith;
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c) A report on sale of drugs and
use of medicinal materials according to Form No. 10 and Form No. 20 in Appendix
II enclosed herewith.
4. Only 01 set of documents
specified in Clause 1, 2, 3 of this Article is required.
Article 54.
Procedures for granting permission to purchase narcotic drugs, psychotropic
drugs, precursor drugs or medicinal materials that are narcotic active
ingredients, psychotropic active ingredients or drug precursors; procedures for
granting permission to sell medicinal materials that are narcotic active
ingredients, psychotropic active ingredients or drug precursors
1. The applicant shall submit an
application directly or by post to:
a) the Ministry of Health if the
applicant is a manufacturer, the applicant already has a certificate of
eligibility for drug export, import and wholesaling, or the applicant is a
health facility, a testing laboratory, a rehabilitation center, an
establishment providing opioid substitution treatment or an establishment
providing training in medicine or pharmacy that needs to purchase drugs for
research or testing purposes;
b)101 The Department of Health of the same province if the
applicant is a drug wholesaler, a retailer, a private health facility, a
research and testing institution, an institution providing training in medicine
or pharmacy, a rehabilitation center, an establishment providing opioid
substitution treatment and a non-commercial pharmacy establishment.
c) 102 Military Medicine Department (Ministry of National
Defense) if the applicant is under the management of the Ministry of National
Defense.
2. When receiving the application,
the receiving authority shall give the applicant Form No. 01 in Appendix II
enclosed herewith.
3. If the application is
satisfactory, the receiving authority shall approve the purchase order or issue
a written permission within 30 days from the day on which the application is
received.
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5. After receiving the supplemented
application, the receiving authority shall give the applicant form No. 01 in
Appendix I enclosed herewith.
a) If the supplemented application
is still unsatisfactory, the receiving authority shall request the applicant to
complete it in accordance with Clause 4 of this Article.
b) If the supplemented application
is satisfactory, the receiving authority shall follow the instructions in
Clause 3 of this Article.
6. Within 06 months from the day on
which additional documents are requested in writing by the receiving authority,
the applicant shall submit additional documents as requested. If the applicant
fails to satisfy such request by the aforementioned deadline or the application
is not satisfactory within 12 months from the first time it is submitted, the
application will be rejected.
Article 55.
Documents and procedures for obtaining permission to retail drugs on the list
of drugs restricted from retailing
1. If the applicant has not
obtained the Certificate of eligibility for pharmacy business that allows drug
retailing:
a) The application shall consist of
Form No. 22 in Appendix II enclosed herewith and the documents specified in
Clause 2d Article 32 hereof;
b) Procedures and time limit for
licensing are the same as those specified in Article 33 hereof.
2. If the applicant has obtained a
Certificate of eligibility for pharmacy business that allows drug retailing:
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b) Procedures and time limit:
- The applicant shall submit the
application directly or by post to the Department of Health of the same
province as the applicant’s business location 103;
- After receiving the application,
the Department of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
- If the application is
satisfactory, the Department of Health shall issue a written permission for
retailing drugs on the list of drugs restricted from retailing within 07
working days from the date of receipt;
- If the application is not
satisfactory, the Department of Health shall request the applicant to complete
the application within 05 working days from the date of receipt;
- After receiving the supplemented
application, the Department of Health shall give the applicant form No. 01 in
Appendix I enclosed herewith. If the supplemented application is still
unsatisfactory, the Department of Health shall inform the applicant in writing
within 05 working days from the date of receipt. If the supplemented
application is satisfactory, the Department of Health shall issue a written
permission for retailing drugs on the list of drugs restricted from retailing
within 07 working days from the day on which the application is received;
- Within 06 months from the day on
which additional documents are requested in writing by the Department of
Health, the applicant shall submit additional documents as requested. If the
applicant fails to satisfy such request by the aforementioned deadline or the
application is not satisfactory within 12 months from the first time it is
submitted, the application will be rejected.
3. Within 05 working days from the
day on which permissions granted, the Department of Health shall publish
information about the retailer and the list of drugs permitted for retailing on
its website.
Article 56.
Responsibility of competent authorities for reporting by traders of controlled
drugs
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2. An application shall only be
considered after adequate reports are submitted.
Chapter IV
EXPORT AND IMPORT OF DRUGS AND MEDICINAL MATERIALS
Section 1.
EXPORT OF CONTROLLED DRUGS, HERBAL MATERIALS ON THE LIST OF CONTROLLED
PRECIOUS, RARE AND ENDEMIC MEDICINAL MATERIAL SPECIES AND VARIETIES
Article 57.
Procedures for issuance of the license to export narcotic drugs, psychotropic
drugs, precursor drugs, medicinal materials that are narcotic active
ingredients, psychotropic active ingredients or drug precursors or combination
drugs that contain narcotic active ingredients, combination drugs that contain
psychotropic active ingredients and combination drugs that contain precursors
1. The export of a drug shall only
be licensed when one of the following requirements is satisfied:
a) The drug is manufactured in
Vietnam, granted a marketing authorization in Vietnam and granted an import
license by a competent authority of the importing country; or
b) The drug is manufactured
overseas, granted a marketing authorization in Vietnam and granted an import
license by a competent authority of the importing country.
2. The export of a medicinal
material shall only be licensed when one of the following requirements is
satisfied:
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b) The material is manufactured
overseas, granted a marketing authorization in Vietnam and granted an import
license by a competent authority of the importing country.
3. Application for the export
license:
a) 01 original copy of the purchase
order according to Form No. 01 or Form No. 02 in Appendix III enclosed
herewith;
b) A report on quantity and origins
of drugs/medicinal materials according to Form No. 03 in Appendix III enclosed
herewith;
c) An original copy of the
unexpired license to import drugs/medicinal materials issued by a competent
authority of the importing country. If the import license is written in a language
other than Vietnamese or English language, a notarized Vietnamese or English
translation shall be included. The import license shall be consularly legalized
in accordance with regulations of law on consular legalization, except for the
cases in which consular legalization is exempted by law.
4. Only 01 set of documents
specified in this Article is required.
Article 58.
Requirements and application for the license to export radiopharmaceuticals,
drugs or active ingredients on the list of drugs and active ingredients banned
from certain fields, toxic drugs or toxic medicinal materials
1. The export of a drug or
medicinal material shall only be licensed when one of the following
requirements is satisfied:
a) The drug or material is
manufactured in Vietnam, whether or not granted the marketing authorization in
Vietnam; or
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2. Application for the export
license:
a) 03 original copies of the
purchase order according to Form No. 04 or Form No. 05 in Appendix III enclosed
herewith;
b)104 (repealed)
c)105 (repealed)
3. Only 01 set of documents
specified in this Article is required.
Article 59.
Requirements and application for the license to export herbal materials on the
list of controlled precious, rare and endemic medicinal material species and
varieties
1. The export of an herbal material
on the List of controlled precious, rare and endemic medicinal material species
and varieties shall only be licensed if it is naturally obtained and is not on
the list of herbs banned from export published by the Minister of Health. In
case of export for non-commercial purposes, regulations of law on biodiversity
shall apply.
2. Application for the export
license:
a) 03 original copies of the
purchase order according to Form No. 06 in Appendix III enclosed herewith;
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c) A copy of the confirmation of
herb origin issued by the People’s Committee of the commune which is authenticated
or bears the exporter’s seal. If a copy bearing the exporter’s seal is
submitted, the original copy shall be produced for comparison when the
application is submitted;
d) A copy of the herbal material
purchase order which is authenticated or bears the exporter’s seal. If a copy
bearing the exporter’s seal is submitted, the original copy shall be produced
for comparison when the application is submitted;
dd) In case of export for
non-commercial purposes, the documents specified in Points c and d of this
Clause are not required.
3. Only 01 set of documents
specified in this Article is required.
Article 60.
Licensing non-commercial export of controlled drugs
1. The non-commercial export of a
controlled drug shall be granted when the drug is licensed for sale in Vietnam
and satisfy one of the following requirements:
a) The drug is personal property
shipped under a lading bill or the outbound passenger’s belongings for
treatment of his/her own disease and is not a controlled medicinal material;
b) The drug is exported as
emergency aid or humanitarian aid;
c) The drug has been granted an
import license to serve humanitarian medical services and is not completely
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a) 07 days’ dose for narcotic drugs
according to the prescription;
b) 10 days’ dose for psychotropic
drugs and precursor drugs according to the prescription;
c) 30 days’ dose for combination
drugs that contain narcotic active ingredients, combination drugs that contain
psychotropic active ingredients, toxic drugs, drugs on the list of banned
substances in certain fields according to the prescription.
3. An application for export of the
drug mentioned in Clause 1a of this Article consists of:
a) Form No. 07 in Appendix III
enclosed herewith;
b) Copies of the prescription and
outpatient's medical record which is authenticated or bears the applicant’s
signature (if the applicant is an individual) or seal (if the applicant is an
organization). These documents shall specify the patient’s name and age; name,
concentration and quantity (or doses) of the drug; dosage; the physician’s name
and signature, address of the hospital or clinic where the physician practices.
If a copy bearing the applicant’s
signature of seal is submitted, the original copy shall be produced for
comparison when the application is submitted;
c)106 (repealed)
d) If any of the documents
mentioned in Point b107 of this
Clause is written in a language other than Vietnamese or English language, a
notarized Vietnamese or English translation shall be included.
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a)108 (repealed)
b) 03 original copies of the
purchase order according to Form No. 01 or Form No. 04 in Appendix III enclosed
herewith;
c) The original copy or certified
true copy of the written approval for use of drugs for emergency aid or
humanitarian aid issued by a competent authority of the importing country;
d) The unexpired license issued by
a competent authority of the importing country for import of narcotic drugs,
psychotropic drugs, drug precursors or combination drugs that contain narcotic
active ingredients, combination drugs that contain psychotropic active
ingredients and combination drugs that contain precursors;
dd) If any of the documents
mentioned in Points c and d of this Clause is written in a language other than
Vietnamese or English language, a notarized Vietnamese or English translation
shall be included. The documents shall be consularly legalized in accordance
with regulations of law on consular legalization, except for the cases in which
consular legalization is exempted by law.
5. An application for export of the
drug mentioned in Clause 1c of this Article consists of:
a)109 (repealed)
b) 03 original copies of the
purchase order according to Form No. 01 or Form No. 04 in Appendix III enclosed
herewith;
c) A report on quantity of drugs
used for humanitarian medical services according to Form No. 08 in Appendix III
enclosed herewith.
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Article 61.
Requirements and application for export of controlled drugs for exhibition
1. The export of a narcotic drug,
psychotropic drug, precursor drug, narcotic active ingredient, psychotropic
active ingredient, drug precursor, combination drug that contains narcotic
active ingredients, combination drug that contains psychotropic active
ingredients or combination drug that contains precursors shall only be licensed
when one of the following requirements is satisfied:
a) It is manufactured in Vietnam
and granted an import license by a competent authority of the importing country
regardless of availability of the marketing authorization in Vietnam;
b) It is manufactured overseas,
granted a marketing authorization in Vietnam and granted an import license by a
competent authority of the importing country.
2. An application for export of a
narcotic drug, psychotropic drug, precursor drug, narcotic active ingredient,
psychotropic active ingredient, drug precursor or combination drug that
contains narcotic active ingredients, combination drug that contains
psychotropic active ingredients or combination drug that contains precursors:
a) 01 original copy of the purchase
order according to Form No. 01 or Form No. 02 in Appendix III enclosed
herewith;
b) An original copy of the
unexpired license to import drugs/medicinal materials issued by a competent
authority of the importing country. If the import license is written in a
language other than Vietnamese or English language, a notarized Vietnamese or
English translation shall be included. The import license shall be consularly
legalized in accordance with regulations of law on consular legalization,
except for the cases in which consular legalization is exempted by law;
c) Only 01 set of documents
specified in this Clause is required.
3. The licensing of export of
radiopharmaceuticals, toxic drugs, toxic medicinal materials, drugs and active
ingredients on the list of substances banned from certain fields for exhibition
shall comply with regulations of law on temporary import of goods.
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1. The export of a narcotic drug,
psychotropic drug, precursor, narcotic active ingredient, psychotropic active
ingredient, drug precursor or combination drug that contains narcotic active
ingredients, combination drug that contains psychotropic active ingredients or combination
drug that contains precursors shall only be licensed when one of the following
requirements is satisfied:
a) It is manufactured in Vietnam
and granted an import license by a competent authority of the importing country
regardless of availability of the marketing authorization in Vietnam;
b) It is manufactured overseas,
granted a marketing authorization in Vietnam and granted an import license by a
competent authority of the importing country.
2. An application for export of a
narcotic drug, psychotropic drug, precursor, narcotic active ingredient,
psychotropic active ingredient, drug precursor or combination drug that
contains narcotic active ingredients, combination drug that contains
psychotropic active ingredients or combination drug that contains precursors:
a) 01 original copy of the purchase
order according to Form No. 01 or Form No. 02 in Appendix III enclosed
herewith;
b) An original copy of the
unexpired license to import drugs/medicinal materials issued by a competent
authority of the importing country. If the import license is written in a
language other than Vietnamese or English language, a notarized Vietnamese or
English translation shall be included. The import license shall be consularly
legalized in accordance with regulations of law on consular legalization,
except for the cases in which consular legalization is exempted by law;
c)110 (repealed)
d) Only 01 set of documents
specified in this Clause is required.
3. The export of a
radiopharmaceutical, toxic drug, toxic medicinal material, drug or active
ingredient on the list of drugs and active ingredients banned from certain
fields shall only be licensed when one of the following requirements is
satisfied:
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b) It is manufactured overseas and
has been granted a marketing authorization in Vietnam.
4. An application for export of a
radiopharmaceutical, toxic drug, toxic medicinal material, drug or active
ingredient on the list of drugs and active ingredients banned from certain
fields:
a) 01 original copies of the
purchase order according to Form No. 04 or Form No. 05 in Appendix III enclosed
herewith;
b)111 (repealed)
Article 63.
Procedures and time limit for licensing export of controlled drugs, herbal
materials on the list of controlled precious, rare and endemic medicinal
material species and varieties
1. Procedures and time limit for
licensing export of controlled drugs, herbal materials on the list of
controlled precious, rare and endemic medicinal material species and varieties
in the cases specified in Articles 57, 58, 59, Clause 1b and Clause 1c Article
60, Clause 1 Article 61 and Article 62 hereof:
a) The applicant shall submit an
application to the Ministry of Health directly or by post;
b) After receiving the application,
the Ministry of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
c) If the application is
satisfactory, the Ministry of Health shall issue the export license within 10
working days from the day on which the application is received;
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dd) After receiving the
supplemented application, the Ministry of Health shall give the applicant form
No. 01 in Appendix I enclosed herewith. If the application is still
unsatisfactory, the Ministry of Health shall request the applicant to complete
it in accordance with Point d this Article. If the supplemented application is
satisfactory, the Ministry of Health shall issue the export license in
accordance with Point c of this Clause;
e) Within 06 months from the day on
which additional documents are requested in writing by the Ministry of Health,
the applicant shall submit additional documents as requested. If the applicant
fails to satisfy such request by the aforementioned deadline or the application
is not satisfactory within 12 months from the first time it is submitted, the
application will be rejected.
2. Procedures and time limit for
issuing the export license in the case specified in Clause 1a Article 60
hereof:
a) The applicant shall submit an
application, directly or by post, to Department of Health of the province where
the exit checkpoint is located or where the patient is residing or where the
applicant’s headquarters are located;
b) After receiving the application,
the Department of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
c) If the application is
satisfactory, the Department of Health shall issue the export license within 07
working days from the day on which the application is received;
d) If the application is not
satisfactory, the Department of Health shall request the applicant in writing
to complete the application within 05 working days from the day on which the
application is received;
dd) After receiving the
supplemented application, the Department of Health shall give the applicant
form No. 01 in Appendix I enclosed herewith. If the application is still
unsatisfactory, the Department of Health shall request the applicant to
complete it in accordance with Point d of this Clause. If the supplemented
application is satisfactory, the Department of Health shall issue the export
license in accordance with Point c of this Clause;
e) Within 03 months from the day on
which additional documents are requested in writing by the Department of
Health, the applicant shall submit additional documents as requested. If the
applicant fails to satisfy such request by the aforementioned deadline or the
application is not satisfactory within 04 months from the first time it is
submitted, the application will be rejected.
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4. The specimens of the export
license and permission for export are provided in Form No. 09, 10, 11, 12, 13
in Appendix III enclosed herewith.
Article 64.
Management of export and import of drugs and medicinal materials
1. Each shipment of narcotic drugs,
psychotropic drugs, precursor drugs, combination drugs that contain narcotic
active ingredients, combination drugs that contain psychotropic active
ingredients, combination drugs that contain precursors or medicinal materials
that are narcotic active ingredients, psychotropic active ingredients or drug
precursors is subject to the issuance of an export license; the quantity of
exported drugs/medicinal materials must not exceed the quantity written on the
import license issued by the competent authority of the importing country.
2. Each export of herbal materials
the list of controlled precious, rare and endemic medicinal material species
and varieties is subject to issuance of an export license.
3. Narcotic drugs, psychotropic
drugs, precursor drugs, radiopharmaceuticals, combination drugs that contain
narcotic active ingredients, combination drugs that contain psychotropic active
ingredients, combination drugs that contain precursors or medicinal materials
that are narcotic active ingredients, psychotropic active ingredients or drug
precursors, herbal materials on the list of controlled precious, rare and
endemic medicinal material species and varieties other than those specified in
Clause 1a Article 60 hereof may only be exported through international
checkpoint.
4. A manufacturer of narcotic drugs,
psychotropic drugs, precursor drugs, medicinal materials that are narcotic
active ingredients, psychotropic active ingredients or drug precursors may
export the drugs or medicinal materials it manufactures.
5. An exporter or importer of
narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that
are narcotic active ingredients, psychotropic active ingredients or drug
precursors may export the drugs or medicinal materials it registered.
6. The applicant for permission for
non-commercial export of controlled drugs specified in Clause 1a Article 60
hereof is responsible for their origin, quality, safety, efficacy and
conformity with the importing country’ regulations.
7. The exporter shall re-import all
the narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials
that are narcotic active ingredients, psychotropic active ingredients or drug
precursors or combination drugs that contain narcotic active ingredients, combination
drugs that contain psychotropic active ingredients and combination drugs that
contain precursors that were temporarily exported for exhibition.
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a) The application shall contain 03
copies of the purchase order according to Form No. 14 in Appendix III and a
copy of the exporter’s Certificate of eligibility for pharmacy business which
is authenticated or bear the exporter’s seal;
b) Procedures for granting the
export license are specified in Clause 1 Article 63 hereof.
Section 2.
IMPORT OF DRUGS WITHOUT THE marketing authorization IN VIETNAM
Article 65.
Requirements and application for licensing import of drugs containing active ingredients
without the marketing authorization of drugs or drugs containing herbal
materials that are used in Vietnam for the first time
1. The import of such a drug shall
only be licensed when the following requirements are satisfied:
a)112 The drug is licensed in one of the following country:
manufacturing country, reference country that is a member state of the
International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH) or Australia;
b)113 The drug falls into one of the following cases:
- The drug is specified in the
guidelines for disease diagnosis, prevention and treatment which are
promulgated and approved by the Ministry of Health
- The drug is used for emergency of
poison control and as an anti-rejection medication;
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c)114 (repealed)
2. Application for the import
license:
a) 03 original copies of the
purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed
herewith;
b) The original copy or a certified
true copy of the certificate of pharmaceutical product;
c) A copy of the document about the
quality standards and drug testing method of the manufacturer which bears the
importer’s seal;
d)115 The original copy of 01 set of specimens of the label
and package insert from the drug production country or the exporting country,
unless such package insert or the summary of product characteristics is
attached to the Certificate of Pharmaceutical Product;
dd) 02 sets of specimens of the
label intended to be used in Vietnam and the package insert in Vietnamese
language which bear the importer’s seal;
e)116 Clinical data about the safety and efficacy of the drug
according to the regulations on drug registration of the Minister of Health.
Documents specified in this point
are not required to be submitted in cases where the drug are licensed for
import according the regulations in this Article and no changes are made to the
information related to the indication, dosage and user.
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h) The original copy or certified
true copy of the certificate of GMP of all facilities participating in the
manufacture of the imported drug if the drug is manufactured by more than one
facility.
Documents specified in this point
are not required to be submitted if the manufacturer has been certified
conformable with GMP principles on the certificate of pharmaceutical product;118
i)119 (repealed)
3. Only 01 set of documents
specified in this Article is required.
Article 66.
Requirements and application for licensing import of drugs containing active
ingredients that already have the marketing authorization in Vietnam but are
not available in sufficient quantity and drugs containing herbal materials that
have already been used in Vietnam but are not available in sufficient quantity
1. The import of such a drug shall
only be licensed when the following requirements are satisfied:
a) The drug is on the list of drugs
not available in sufficient quantity published by the Minister of Health;
b) The drug is licensed in one of
the following country: the manufacturing country, a reference country that is a
member state of the ICH or Australia.
2. Application for the import
license:
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b) The original copy or a certified
true copy of the certificate of pharmaceutical product;
c)120 Quality documents according to the regulations of the
Minister of Health on the use of ASEAN Common Technical Dossier (ACTD) in drug
registration or quality standards and results of bioequivalence study according
to clause 7, Article 76 hereof;
d)121 The original of 01 set of specimens of the label and
package insert from the drug production country or the exporting country,
unless both of them or the summary of product characteristics are attached to
the Certificate of Pharmaceutical Product;
dd) 02 sets of specimens of the
labels intended to be used in Vietnam and the package insert in Vietnamese
language which bear the importer’s seal;
e)122 Clinical document if required by regulations of the
Minister of Health on use of ACTD for drug registration.
Documents specified in this point
are not required to be submitted in cases where the drug has been licensed for
import according the regulations in this Article and no changes have been made
to the information about the indication, dosage and user;
g) Regarding a traditional drug
that contain a herbal material that has been used in Vietnam as a medicinal
material, it is required to have a clinical document proving its safety and efficacy
according to Article 89 of the Law on Pharmacy and documents proving the
traditional concoction or combination method;
h) A sale report (Form No. 18 in
Appendix III enclosed herewith) if the imported drug is a narcotic drug,
psychotropic drug, precursor drug, combination drug that contains narcotic
active ingredients, combination drug that contains psychotropic active
ingredients, combination drug that contains precursors123;
i) The original copy or certified
true copy of the certificate of GMP of all facilities participating in the
manufacture of the imported drug if the drug is manufactured by more than one
facility.
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k)125 (repealed)
3. Only 01 set of documents
specified in this Article is required.
Article 67.
Requirements and application for licensing import of drugs to meet urgent need
of national defense and security, epidemic control or disaster relief
1. The import of a drug shall only
be licensed if it has been licensed in at least one other country and:
a) its import is requested by the
Ministry of National Defense to meet urgent need of national defense;
b) its import is requested by the
Ministry of Public Security to meet urgent need of security;
c) The drug is approved by the
Ministry of Health as suitable for urgent epidemic control or disaster relief.
2. Application for the import
license:
a) 03 original copies of the
purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed
herewith;
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c)126 An original copy or a copy bearing the issuer’s seal of
the written request or approval issued by any of the competent authorities
specified in Clause 1a, 1b or 1c of this Article which specifies: the active
ingredients of the modern drug or biologicals or herbal materials of the herbal
drug or traditional drug, dosage form, concentration of active ingredients of
the modern drug or biologicals or quantity of herbal materials of the herbal
drug or traditional drug, package contents, manufacturer and manufacturing
country.
3. Only 01 set of documents
specified in this Article is required.
Article 68.
Requirements and application for licensing import of drugs for special
treatment
1. The import of such a drug shall
only be licensed when one of the following requirements is satisfied:
a)127 (repealed)
b)128 The drug does not satisfy the treatment requirements
and is:
- Used for emergency of poison
control and as anti-rejection medication; or
- Included in the List of Rare
Drugs; or
- Specified in the guidelines on
prevention and treatment for anaphylactic shock promulgated and approved by the
Ministry of Health; or
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c) The Minister of Health shall
decide licensing of vaccines in special cases with limited quantity according
to data about its satisfactory quality, efficacy and safety.
2.129 (repealed)
3. An application for import of a
drug mentioned in Clause 1b or 1c of this Article consists of:
a) 03 original copies of the
purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed
herewith;
b) Documents proving the quality,
safety and efficacy of the vaccine;
c)130 An original copy of the document of the health facility
which contains the reason for importing the drug, the quantity of patients who
need to use it and quantity of drug needed, as well as the commitment to assume
responsibility for the use of the imported drug. The document shall be enclosed
with the original copy or the copy bearing the seal of the health facility, as
well as the minutes of meeting of the Drug and Treatment Council about the
import demand of such drug. If such Council does not exist or the drug used for
the emergency of poison control is needed for patients who are clearly listed
by the health facility, then the minutes of meeting are not required.
d) The list of drugs to be imported
according to Form No. 10, 20 or 21 in Appendix III enclosed herewith;
dd) A report on the quantity,
efficacy (except vaccines) and safety of drugs used according to Form No. 22 in
Appendix III enclosed herewith;
e) The original copy of the foreign
exporter and manufacturer’s commitment to quality, safety and efficacy of the
vaccine131 supplied to the
Vietnamese importer according to Form No. 23 in Appendix III enclosed herewith;
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4. Only 01 set of documents
specified in Clauses 2 and 3 of this Article is required.
Article 69.
Requirements and application for licensing import of rare drugs
1. The import of such a drug shall
only be licensed when the following requirements are satisfied:
a) It is on the list of rare drugs;
b) It is licensed in at least one
other country.
2. Application for the import
license:
a) 03 original copies of the
purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed
herewith;
b) The original copy or a certified
true copy of the certificate of pharmaceutical product;
c) A copy of the document about the
quality standards and drug testing method of the manufacturer which bears the
importer’s seal;
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dd) 02 sets of specimens of the
labels intended to be used in Vietnam and the package insert in Vietnamese
language which bear the importer’s seal;
e) A sale report (Form No. 18 in
Appendix III enclosed herewith) if the imported drug is a narcotic drug,
psychotropic drug, precursor drug, combination drug that contains narcotic
active ingredients, combination drug that contains psychotropic active
ingredients, combination drug that contains precursors134;
g) The original copy or certified
true copy of the certificate of GMP of all facilities participating in the
manufacture of the imported drug if the drug is manufactured by more than one
facility.
Documents specified in this point
are not required to be submitted if the manufacturer has been certified
conformable with GMP principles on the certificate of pharmaceutical product;135
h)136 (repealed)
3. Only 01 set of documents
specified in this Article is required.
Article 70.
Requirements and application for licensing drugs that have the same trade name,
active ingredients, concentration and dosage form as those of a original
brand-name drug having the marketing authorization in Vietnam, are manufactured
by the same manufacturer of the original brand-name drug or by an authorized
manufacturer and are sold at a lower price than that of the original brand-name
drug sold in Vietnam
1. The import of such a drug shall
only be licensed when the following requirements are satisfied:
a) Requirements in Clause 2dd
Article 60 of the Law on Pharmacy are satisfied;
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c) The drug is licensed and
exported to Vietnam from the manufacturing country, a reference country that is
a member state of the ICH or Australia;
d) The drug is not a
radiopharmaceutical, vaccine or biological.
2. Application for the import
license:
a) 03 original copies of the
purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed
herewith;
b)137 (repealed)
c) Documents proving that the drug
is lawfully marketed in the manufacturing country or a reference country;
d) 01 set of specimens of the label
and package insert of the drug marketed in reality in manufacturing country
which bear the importer’s seal;
dd) 02 sets of specimens of the
secondary label and package insert in Vietnamese language which bear the
importer’s seal. The content of the package insert in Vietnamese language must
be consistent with the content of the label of the original brand-name drug
approved by the Ministry of Health regarding the original brand-name drug
having the marketing authorization in Vietnam.
3. Only 01 set of documents
specified in this Article is required.
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1. The import of such a drug shall
only be licensed when the following requirements are satisfied:
a) The use of the drug for a health
program of the State is approved by a competent authority;
b)138 The drug is licensed in one of the following countries:
the manufacturing country, the member state of the ICH or Australia.
2. Application for the import
license:
a) 03 original copies of the
purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed
herewith;
b) The original copy or a certified
true copy of the certificate of pharmaceutical product;
c)139 Quality documents according to the regulations of the
Minister of Health on the use of ACTD in drug registration or quality standards
and results of bioequivalence study according to Clause 7, Article 76 hereof;
d)140 Clinical document if required in some cases by the
regulations of the Minister of Health on drug registration.
Documents specified in this point
are not required to be submitted in cases where the drug has been licensed for
import according the regulations in this Article and no changes have been made
to the information about the indication, dosage and user;
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e) 02 sets of specimens of the
labels intended to be used in Vietnam and the package insert in Vietnamese
language which bear the importer’s seal;
g) The original copy or certified
true copy of the written approval issued by a competent authority for use of
the drug for the health program of the State;
h) The original copy or certified
true copy of the certificate of GMP of all facilities participating in the
manufacture of the imported drug if the drug is manufactured by more than one
facility.
Documents specified in this point
are not required to be submitted if the manufacturer has been certified
conformable with GMP principles on the certificate of pharmaceutical product;142
i)143 (repealed)
3. Only 01 set of documents
specified in this Article is required.
Article 72.
Requirements and application for licensing import of drugs as emergency aid or
humanitarian aid
1.144 The import of such drug shall only be licensed in the
manufacturing country or the country which is the member state of ICH or
Australia, when:
a) The drug as an emergency aid is
carried by the foreign humanitarian medical team to use for their humanitarian
medical services.
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c) The drug as an emergency aid is
used for the state medical programs or projects.
d) The drug as an emergency aid is
not specified in points a, b and c of this clause and is not narcotic drug,
radiopharmaceutical or vaccine.
2. Application for the import
license:
a) 145 The import order using form No. 24, 25 or 26 in
Appendix III hereto;
b) The original copy of the aid
recipient’s document specifying the quantity of each type of drugs received as
emergency aid or humanitarian aid and the commitment to use the drugs for
intended purposes;
c)146 The original copy or the certified true copy of the
written approval issued by a regulatory agency for the use of foreign drugs as
an emergency aid in state medical programs or projects; if the drugs are
imported, the original copy of the written approval issued by the regulatory
agency for humanitarian medical services is required, according to Clause 1a of
this Article;
d) The original copy or a certified
true copy of the certificate of pharmaceutical product;
dd)147 Quality documents according to the regulations of the
Minister of Health on the use of ACTD in drug registration or quality standards
and results of bioequivalence study according to clause 7, Article 76 hereof;
e)148 Clinical document if required in some cases by the
regulations of the Minister of Health on drug registration;
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g)149 The original of 01 set of specimens of the label and
package insert from the drug production country or the exporting country,
unless both of them are attached to the Certificate of Pharmaceutical Product;
h)150 02 sets of specimens of the label and package insert in
Vietnamese which bear the importer's seal;
i) The original copy or certified
true copy of the certificate of good practice of all facilities participating
in the manufacture of the imported drug if the drug is manufactured by more
than one facility;
Documents specified in this point
are not required to be submitted if the manufacturer has been certified
conformable with GMP principles on the certificate of pharmaceutical product;151
k)152 The documents specified in points d, dd, e, g, h and i
are not required in cases where the drug is imported in accordance with Clause
1a and 1b of this Article. However, there must be a written commitment about
the drug licensed in the manufacturing country or the member state of ICH or
Australia. Also, the written commitment of the facility receiving humanitarian
aids must clearly specify the list of patients in need of the drug according to
Clause 1b of this Article.
3. Only 01 set of documents
specified in this Article is required.
Article 73.
Requirements and application for licensing import of drugs for the purpose of
clinical trial, bioequivalence study, bioavailability assessment, testing or
scientific research
1. The import of such a drug shall
only be licensed when one of the following requirements is satisfied:
a) The drug is used for clinical
trial under a research outline approved by the Minister of Health according to
Clause 1 Article 94 of the Law on Pharmacy;
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c) The drug is used as a reference
drug in bioequivalence study. If the reference drug is a new drug, it may only
be used under an approved research outline according to Clause 1 Article 100 of
the Law on Pharmacy;
d) The drug is used for testing by
drug manufacturers or drug-testing laboratories;
dd) The drug is used for scientific
research other than those mentioned in Points a, b and c of this Clause.
2. Application for the import
license:
a) 03 original copies of the
purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed
herewith;
b) The original copy or certified
true copy of the written approval issued by a competent authority or
organization in the cases mentioned in Clause 1a, 1b and 1dd of this Article;
c) The original copy or certified
true copy of the written approval for the bioequivalence study outline
according to Article 100 of the Law on Pharmacy in case of a new drug mentioned
in Clause 1c of this Article.
d) The importer’s document bearing
the importer’s seal specifying the purposes and quantity of imported drugs and
commitment to use the drugs for intended purposes;
dd)153 (repealed)
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Article 74.
Requirements and application for import of drugs for exhibition
1. An application for licensing
import of combination drugs that contain narcotic active ingredients, combination
drugs that contain psychotropic substances or combination drugs that contain
precursors for display a medical, pharmaceutical or medical equipment fair or
exhibition consists of:
a) 01 original copy of the purchase
order according to Form No. 16 in Appendix III enclosed herewith;
b)154 (repealed)
2. Only 01 set of documents specified
in Clause 1 of this Article is required.
3. The import of drugs other than
those mentioned in Clause 1 of this Article shall only be licensed when all of
the following requirements are satisfied:
a) The drug is used for display a
medical, pharmaceutical or medical equipment fair or exhibition;
b) The drug is not a narcotic drug,
psychotropic drug, precursor drug or radiopharmaceutical.
4. The import of the drugs
mentioned in Clause 3 of this Article shall comply with regulations of law on
temporary import and re-export of goods.
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1. The non-commercial import of a
drug shall only be licensed when one of the following requirements is
satisfied:
a) The drug is personal belonging
of an inbound person which is shipped under a lading bill, personal belonging
of an inbound person for treatment of his/her own disease.
b) The drug is not a narcotic drug,
psychotropic drug or precursor drug and is property of a diplomatic mission,
consular office or representative office of an international organization in
Vietnam or overseas diplomatic mission of Vietnam, its employees, organizations
introduced by a diplomatic mission or overseas diplomatic mission of Vietnam.
2. The import of drugs mentioned in
Clause 1 of this Article is subject to issuance of an import license, unless:
a) The quantity of drugs to be
imported does not exceed 07 days’ dose for narcotic drugs or 10 days’ dose for
psychotropic drugs and precursor drugs according to the prescription;
b) The drug is not a narcotic drug,
psychotropic drug or precursor drug, the total customs value of a shipment does
not exceed USD 200 according to the inter-bank exchange rate on the customs
clearance date and not more than 03 shipments are received by an organization
or individual in a year.
If the drug is used for treatment
of a disease on the list of fatal diseases in the Government's Decree No.
134/2016/ND-CP , the customs value of a shipment must not exceed VND 10,000,000
and not more than 04 shipments are received by an individual in a year.
3. Application for the import
license:
a) Form No. 27 in Appendix III
enclosed herewith;
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c) A certified true copy of a copy
bearing the applicant’s signature or seal of the prescription or outpatient
medical record. These documents shall specify the patient’s name and age; name,
concentration and quantity (or doses) of the drug; dosage; the physician’s name
and signature, address of the hospital or clinic where the physician practices.
If a copy bearing the applicant’s
signature of seal is submitted, the original copy shall be produced for
comparison when the application is submitted.
The documents specified in Clause
3c of this Article are not required in the case specified in Clause 1b hereof.
d)156 (repealed)
4. Only 01 set of documents
specified in this Article is required.
Article 76.
Documents in the application drug import
1. In the cases of drug import
specified in Article 65, 66, 69, 71157
and Clause 1a Article 68 hereof, a separate purchase order shall be made
separately for each drug, unless all of the following elements of the drugs are
the same:
a) Drug name;
b) Dosage form and route of
administration;
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d) Quality standards;
dd) Expiration date;
e) Name and address of the
manufacturer.
2. If any of the documents in the
application is written in a language other than Vietnamese or English language,
a notarized Vietnamese or English translation shall be included.
3. The following documents shall be
consularly legalized in accordance with regulations of law on consular
legalization, except for the cases in which consular legalization is exempted
by law:
a) The certificate of
pharmaceutical product;
b)158 (repealed)
c) The Certificate of GMP;
d)159 The package insert of the drug licensed in the
manufacturing country or the exporting country, except for the cases specified
in Clause 2d, Article 66, Clause 2d, Article 69, Clause 2dd, Article 71 and
Clause 2g, Article 72 hereof.
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a) Requirements specified in
Clauses 2, 3 and 6 of this Article are satisfied;
b) The certificate bears the
signer’s signature, name and position and the issuer’s seal;
c) The signer’s signature, name and
position and the issuer’s seal are certified by a diplomatic missions, consular
office or another organization authorized to perform consular tasks in the home
country;
d) The certificate of
pharmaceutical product undergoing consular legalization is the original copy;
dd) It is certified that the drug
is licensed160 in country in
which the certificate of pharmaceutical product is issued;
e) In the cases where the drug is
manufactured by more than one facilities, the certificate must specify the
name, address and roles of each facility;
g) The certificate complies with
the specimen provided by World Health Organization (WHO) which is applied to
the quality certification system or products licensed to be sold
internationally.
5.161 The specimens of the label and package insert of a drug
licensed in the manufacturing country or the exporting country must satisfy the
following requirements, except the drugs that have the same trade name, active
ingredients, concentration and dosage form as those of a proprietary drug
having the marketing authorization in Vietnam, are manufactured by the same
manufacturer of the proprietary drug or by an authorized manufacturer and are
sold at a lower price than that of the proprietary drug sold in Vietnam
according Article 70 hereof:
a) Requirements specified in Clause
3 of this Article are satisfied;
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c)163 The original of the specimen of package insert
undergoing consular legalization;
d)164 The specimen of the label specified in Clause 2d,
Article 65; samples of the label and the package insert which are specified in
Clause 2d, Article 66, Clause 2d, Article 69, Clause 2dd, Article 71 and Clause
2g, Article 72 must bear the seal of the manufacturer or the owner of the
product or product license (stamped on the Certificate of Pharmaceutical
Product) and the importer.
6. Legal documents in the
application must be unexpired when the application is submitted.
7.165 Quality standards and results of the bioequivalence
study:
a) Copies which bear the seal of
the manufacturer or the owner of the product or product license (stamped on the
Certificate of Pharmaceutical Product) and of the importer must be provided;
b) Results of bioequivalence study
shall only be submitted if required by the regulations of the Minister of
Health on drug registration.
The documents specified in this
point are not required in cases where drugs are produced and licensed
(specified on the Certificate of Pharmaceutical Product) in the country that is
the permanent member or founder of ICH or Australia.
Article 77.
Procedures and deadline for licensing import of drugs without the marketing
authorization in Vietnam
1. In cases of drug import specified
in Articles 65, 66, 69, 71, Clause 1c and 1d, Article 72 hereof:166
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b) After receiving the application,
the Ministry of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
c) If the application is
satisfactory, the Ministry of Health shall issue the import license within 60
days if clinical documents and documents proving equivalence to reference
biologicals are not required, or within 90 days if clinical documents and
documents proving equivalence to reference biological are required. The import
license shall be issued on the basis of counsel given by the certification
advisory council;
d) If the application is not
satisfactory, the Ministry of Health shall request the applicant in writing to
complete it within 60 days if clinical documents and documents proving
equivalence to reference biological are not required, or within 90 days if
clinical documents and documents proving equivalence to reference biologicals
are required;
dd) After receiving the
supplemented application, the Ministry of Health shall give the applicant form
No. 01 in Appendix I enclosed herewith. If the application is still
unsatisfactory, the Ministry of Health shall request the applicant to complete
it in accordance with Point d this Article. If the supplemented application is
satisfactory, the Ministry of Health shall issue the import license in
accordance with Point c of this Clause;
e) Within 06 months from the day on
which additional documents are requested in writing by the Ministry of Health,
the applicant shall submit additional documents as requested. If the applicant
fails to satisfy such request by the aforementioned deadline or the application
is not satisfactory within 12 months from the first time it is submitted, the
application will be rejected.
g)167 In cases where drugs imported for provision of
humanitarian medical services are approved by the competent authority and the
documents specified in Points d, dd, e, g, h, i, clause 2, Article 72 hereof
are not mentioned but the drugs are essential for the disease treatment, the
Minister of Health shall consider approving the application on the basis of counsel
given by the certification advisory council.
2. In the cases of drug import
specified in Article 67 hereof:
a) The applicant shall submit an
application to the Ministry of Health directly or by post;
b) After receiving the application,
the Ministry of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
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d) If the application is not
satisfactory, the Ministry of Health shall request the applicant in writing to
complete it within 03 working days from the day on which the application is
received;
dd) After receiving the
supplemented application, the Ministry of Health shall give the applicant form
No. 01 in Appendix I enclosed herewith. If the application is still
unsatisfactory, the Ministry of Health shall request the applicant to complete
it in accordance with Point d this Article. If the supplemented application is
satisfactory, the Ministry of Health shall issue the import license in
accordance with Point c of this Clause;
e) If the applicant fails to
provide the documents mentioned in Clause 2b Article 67 hereof but the drugs
are essential for disease prevention and treatment, the Minister of Health
shall consider the application on the basis of commitments made by relevant
Ministries.
3. In the cases of drug import
specified in Article 70, 73, Clause 1 Article 74, Clause 1b and Clause 1c
Article 68 hereof:168
a) The applicant shall submit an
application to the Ministry of Health directly or by post;
b) After receiving the application,
the Ministry of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
c) If the application is
satisfactory, the Ministry of Health shall issue the import license within 15
working days from the day on which the application is received;
d) If the application is not
satisfactory, the Ministry of Health shall request the applicant in writing to
complete it within 15 working days from the day on which it is received;
dd) After receiving the
supplemented application, the Ministry of Health shall give the applicant form
No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory,
the Ministry of Health shall request the applicant to complete it in accordance
with Point d this Article. If the supplemented application is satisfactory, the
Ministry of Health shall issue the import license in accordance with Point c of
this Clause;
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4. In the cases of drug import
specified in Article 75 hereof:
a) The applicant shall submit an
application, directly or by post, to Department of Health of the province where
the entry checkpoint is located or where the patient is residing or where the
applicant’s headquarters are located;
b) After receiving the application,
the Department of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
c) If the application is
satisfactory, the Department of Health shall issue the import license within 07
working days from the day on which the application is received;
d) If the application is not
satisfactory, the Department of Health shall request the applicant in writing
to complete it within 07 working days from the day on which it is received;
dd) After receiving the
supplemented application, the Department of Health shall give the applicant
form No. 01 in Appendix I enclosed herewith. If the application is still
unsatisfactory, the Department of Health shall request the applicant to
complete it in accordance with Point d of this Clause. If the supplemented
application is satisfactory, the Department of Health shall issue the import
license in accordance with Point c of this Clause;
e)169 Within 03 months, from the date on which the additional
documents are requested in writing by the Ministry of Health, the applicant
shall submit additional documents as requested. If the applicant fails to
satisfy such request by the aforementioned deadline or the application is not
satisfactory within 04 months from the first time it is submitted, the
application will be rejected.
5. Within 10 working days from the
day on which the license for drug import is issued according to Articles 65
through 69 hereof, the Ministry of Health shall publish information on its
website in accordance with Clause 6 Article 60 of the Law on Pharmacy.
6. The Ministry of Health shall
publish on its website information about drugs used for emergency treatment,
poison control and vaccines used in certain cases with limited amounts that are
licensed for import according to Clause 1b and Clause 1c Article 68 hereof,
including information about the importer, manufacturer, quantity of the drug
licensed for import, the drug name, dosage form, route of administration,
concentration/content of active ingredients, import license number and date of
issuance, and health facilities and vaccination centers in need of the drug.
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Article 78.
Management of import of drugs without the marketing authorization in Vietnam
1. The drug that contains an active
ingredient that is not granted the marketing authorization or an herbal
material that is used in Vietnam for the first time or a drug licensed for
import according to Article 65 and Article 69 hereof may only be supplied for
health facilities.
2.170 (repealed)
3. As for drugs used for emergency
treatment and poison control, and vaccines used in some special cases with
limited amounts and other drugs licensed for import according to Clause 1b and
1c, Article 68 hereof:171
a) These drugs may only be supplied
for health facilities and vaccination centers that wish to import them. The
health facility or vaccination center shall inform the users, patients or their
relatives of information about the drugs licensed for import without adequate
legal and technical documents. The drug may only be used with the consent of
the user, patient or patient’s relative.
b) The importer, health facility or
vaccination center mentioned in Point a of this Clause may sell these drugs to
other health facilities and vaccination centers. The buyer shall have adequate
documents specified in Clause 3c and Clause 3d Article 68 hereof and take the
responsibility specified in Point a of this Clause.
c)172 The regulations in clause 4, Article 103 of the Law on
Pharmacy are not required to be implemented. The importer of drugs requiring
cold or deep freezing storage shall retain the data sheets which record the
storage conditions (cold chain) during the transport process of imported batch
of drugs (bearing the seal of the importer). Such storage conditions are
recorded by using the temperature data logger and from the freeze indicator (if
any).
4. Before being launch, a batch of
drug that has the same trade name, active ingredients, concentration/content
and dosage form as those of a original brand-name drug having the marketing
authorization in Vietnam, is manufactured by the same manufacturer of the
original brand-name drug or by an authorized manufacturer and is sold at a
lower price than that of the original brand-name drug sold in Vietnam specified
in Article 70 hereof shall undergo quality inspection by an authority
specialized in testing drugs and medicinal materials according to quality
standards applied to original brand-name drugs having the marketing
authorization in Vietnam.
5. Drugs licensed for import to
serve health programs of the State, clinical trial, research or testing shall
be used for intended purposes.
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7. Drugs licensed for import to be
displayed at a medical, pharmaceutical or medical device fair according to
Article 74 hereof shall be completely re-exported after the fair is ended and
must not be used or sold in Vietnam.
8. The applicant for permission for
non-commercial import of drugs according to Article 75 hereof is responsible
for their origin and quality.
Section 3.
IMPORT OF CONTROLLED DRUGS HAVING THE marketing authorization IN VIETNAM AND
CONTROLLED MEDICINAL MATERIALS
Article 79.
Composition of the application for licensing import of controlled drugs having
the marketing authorization in Vietnam
An application for the license to
import narcotic drugs, psychotropic drugs, precursor drugs, combination drugs
that contain narcotic active ingredients, combination drugs that contain
psychotropic active ingredients, combination drugs that contain precursors or
drugs on the list of banned substances in certain fields having an unexpired
marketing authorization in Vietnam consists of:
1. 01 original copy of the purchase
order according to Form No. 33 or 34 in Appendix III enclosed herewith.
2. A report on sale of the drug
according to Form No. 18 in Appendix III enclosed herewith, except for toxic
drugs.
3.173 For the drugs specified in the list of drugs and active
ingredients banned from certain fields, a written explanation enclosed with
documentary evidence are required if the total quantity of imported drugs and
remaining drugs specified in the order form and the quantity of drugs to be
imported according to the issued Import License exceeds 150% of the total
actual business demand in 01 year before the time of making the order.
4. Only 01 set of documents
specified in this Article is required.
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1. An application for the license
to import controlled medicinal materials consists of:
a)174 01 original of the purchase order using form No. 35, 36
or 41 in Appendix III hereto;
b) A copy of the document about the
quality standards and medicinal material testing method of the manufacturer
which bears the importer’s seal;
c) A certified true copy of the
manufacturing license issued by a competent authority of the exporting country.
The manufacturing license shall be consularly legalized in accordance with
regulations of law on consular legalization, except for the cases in which
consular legalization is exempted by law;
d)175 A report on the use of medicinal materials other than
toxic medicinal materials using form No. 37 in Appendix II hereto, and a report
on the sale of semi-finished drugs produced from medicinal materials other than
toxic medicinal materials, using form No. 38 in Appendix III hereto.
The sale report specified in this
point is not required in cases where medicinal materials and reference
materials are imported for testing or research;
dd)176 The plan for production, use or sale of imported
medicinal materials and the plan for sale of semi-finished drugs produced from
imported medicinal materials other than toxic medicinal materials;
The plan for production, use or
sale of imported medicinal materials and the plan for sale of semi-finished
drugs produced from imported medicinal materials other than toxic medicinal
materials.
For the imported drugs specified in
the list of drugs and active ingredients banned from certain fields,
documentary evidence is required if the total quantity of imported drugs and
remaining drugs specified in the order form and the quantity of imported
materials which have been granted the Import License exceeds 150% of the total
actual business demand in 01 year before the time of making the order;
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g) If the medicinal materials have
to be imported for testing or research, the original copy of the importer’s
document specifying the purposes and quantity of materials to be imported and
the commitment to use them for intended purposes;
h) In the cases where a controlled
medicinal material that does not have the marketing authorization in Vietnam or
not on the list of active ingredients, excipients or semi-finished drugs used
for production of drugs that are already granted the marketing authorization in
Vietnam is imported to concoct prescription drugs by pharmacies or health
facilities serving epidemic control, the concocting facility’s written request
according to Form No. 39 in Appendix III enclosed herewith.
2. If any of the documents
mentioned in Clause 1b and 1c of this Article is written in a language other
than Vietnamese or English language, a notarized Vietnamese or English
translation shall be included.
3. Only 01 set of documents
specified in Clauses 1 and 2 of this Article is required
4. Import of medicinal materials
that are narcotic active ingredients, psychotropic active ingredients or drug
precursors for exhibition shall not be licensed.
5. Procedures for import of toxic
medicinal materials and active ingredients on the list of substances banned
from certain fields for exhibition are specified in Article 83 hereof.
Article 81.
Procedures and deadlines for licensing import of controlled drugs having an
unexpired marketing authorization in Vietnam and controlled medicinal materials
1. The applicant shall submit an
application to the Ministry of Health directly or by post.
2. After receiving the application,
the Ministry of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith.
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4. If the application is not
satisfactory, the Ministry of Health shall request the applicant in writing to
complete it within 15 working days from the day on which it is received.
5. After receiving the supplemented
application, the Ministry of Health shall give the applicant form No. 01 in
Appendix I enclosed herewith. If the supplemented application is still
unsatisfactory, the Ministry of Health shall request the applicant to complete
it in accordance with Clause 4 of this Article. If the supplemented application
is satisfactory, the Ministry of Health shall issue the import license in
accordance with Clause 3 of this Article.
6. Within 06 months from the day on
which additional documents are requested in writing by the Ministry of Health,
the applicant shall submit additional documents as requested. If the applicant
fails to satisfy such request by the aforementioned deadline or the application
is not satisfactory within 12 months from the first time it is submitted, the
application will be rejected.
7. The specimens of the import
license and permission for import are provided in Form No. 28, 29, 30, 40 or 44
in Appendix III enclosed herewith.
Section 4.
IMPORT OF MEDICINAL MATERIALS WITHOUT THE MARKETING AUTHORIZATION IN VIETNAM
OTHER THAN CONTROLLED MEDICINAL MATERIALS; IMPORT OF REFERENCE MATERIALS AND
PRIMARY PACKAGES OF DRUGS
Article 82.
Requirements and application for licensing import of active ingredients, herbal
materials, semi-finished drugs and semi-finished herbal materials as samples
for testing or research
1. Import of an active ingredient,
herbal material, semi-finished drug or semi-finished product used for
production of herbal drugs in the form of glue, powder, extract, essential oil,
resin, gum, gel or agar (hereinafter referred to as “semi-finished herbal
material”) without a marketing authorization in Vietnam shall be licensed if:
a) it is used for testing or
research by a drug manufacturer or a facility specialized in testing or
researching drugs or medicinal materials; or
b) it is used for a scientific
research approved by a competent authority.
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a) 03 original copies of the
purchase order according to Form No. 36 or 41 in Appendix III enclosed
herewith;
b)178 (repealed)
c) The original copy or certified
true copy of the written approval issued by a competent authority in the cases
mentioned in Clause 1b of this Article.
3. Only 01 set of documents
specified in this Article is required.
Article 83.
Import of active ingredients, semi-finished drug, herbal materials and
semi-finished herbal materials for exhibition
1. Medicinal materials may only be
imported for display a medical, pharmaceutical or medical equipment fair or
exhibition.
2. The import of medicinal
materials for exhibition shall comply with regulations of law on temporary import
of goods.
3. The medicinal materials that are
licensed for import in accordance with this Article must be completely
re-exported after the exhibition or fair is ended and must not be sold in
Vietnam.
Article 84.
Composition of the application for licensing import of active ingredients,
herbal materials, semi-finished drugs and semi-finished herbal materials for
manufacture of drugs for export
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a) 03 original copies of the
purchase order according to Form No. 36 or 41 in Appendix III enclosed
herewith;
b)179 (repealed)
c)180 (repealed)
2. Only 01 set of documents
specified in this Article is required.
Article 85.
Requirements and application for licensing import of active ingredients,
semi-finished drug, herbal materials and semi-finished herbal materials to
produce drugs serving national defense and security, epidemic control or
disaster relief
1. The import of a medicinal
material drug shall only be licensed if it is imported to manufacture:
a) drugs serving national defense;
b) drugs serving security
protection; or
c) drugs serving epidemic control
or disaster relief, including drugs concocted according to prescriptions by
pharmacies or health facilities. The import of herbal materials for concoction
of drugs according to prescriptions by pharmacies and health facilities shall
comply with Article 87 hereof.
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a) 03 original copies of the
purchase order according to Form No. 36 or 41 in Appendix III enclosed
herewith;
b) If the material is imported for
production of drugs serving national defense and security, the original copy of
the written request of the Ministry of National Defense or the Ministry of
Public Security which specifies the drug name, the manufacturer’s name, active
ingredients and concentration/content thereof, dosage form, package contents,
route of administration and indications;
c) If the material is imported for
production of drugs serving epidemic control or disaster relief, a written
approval for the list of drugs issued by the Ministry of Health which specifies
the drug name, the manufacturer’s name, active ingredients and
concentration/content thereof, dosage form, package contents, route of administration
and indications;
d) If the material is importer for
production or concoction of drugs according to prescriptions at pharmacies or
health facilities, the written request of the manufacturing facility or
concocting facility according to Form No. 42 in Appendix III enclosed herewith;
dd)181 (repealed)
e) A copy of the document about the
quality standards and medicinal material testing method of the manufacturer
which bears the importer’s seal;
g) A certified true copy of the
manufacturing license issued by a competent authority of the exporting country.
The manufacturing license shall be consularly legalized in accordance with
regulations of law on consular legalization, except for the cases in which
consular legalization is exempted by law;
h) If any of the documents
mentioned in Points e and g of this Clause is written in a language other than
Vietnamese or English language, a notarized Vietnamese or English translation
shall be included.
3. Only 01 set of documents specified
in this Article is required.
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1. An application for the import
license consists of:
a) 03 original copies of the
purchase order according to Form No. 43 in Appendix III enclosed herewith;
b)182 (repealed)
2. Only 01 set of documents
specified in this Article is required.
Article 87. Composition of the application for
licensing import of herbal materials in the cases other than those specified in
Articles 82 through 86 hereof 183
1. An application for the import
license consists of:
a) 03 original copies of the
purchase order according to Form No. 41 in Appendix III enclosed herewith;
b) Documents proving that quality
standards of the herbal material are conformable with the National Technical
Regulation on herbal materials according to Vietnam’s pharmacopoeia or a
foreign pharmacopoeia recognized by the Ministry of Health.
If the National Technical
Regulation on the herbal material is not available in Vietnam’s pharmacopoeia
or a foreign pharmacopoeia recognized by the Ministry of Health, the applicant
shall provide quality standards including the testing method which has been
evaluated by a state-owned testing laboratory;
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d)184 Certified and consularly legalized copies of the
license to practice pharmacy issued by competent authority of the home country.
If the home country’s competent authority does not issue license to practice
pharmacy to suppliers of herbal materials and/or semi-finished herbal
materials, the suppliers shall submit certified copies of business license or
documents of equivalent legitimacy issued by competent authority of home
countries covering pharmacy business. Foreign suppliers of herbal materials
and/or semi-finished herbal materials are not required to comply with Clause 15
Article 91 hereof if they possess adequate documents stated under this Clause;
dd)185 Certified and consularly legalized copies of the
certificate of GMP of manufacturing facilities issued by the home country’s
competent authority. If the home country’s competent authority does not issue
the certificate of GMP, facilities shall then submit a certified copy of the
license to manufacture or documents of equivalent legitimacy as certificate of
GMP covering production of herbal materials and/or semi-finished herbal
materials;
e) A copy bearing the importer’s
seal of the manufacturer’s document authorizing the foreign exporter to export
herbal materials, unless the manufacturer is also the exporter. The content of
such document is specified in Clause 15dd Article 91 hereof.
2. Only 01 set of documents
specified in this Article is required.
Article 88.
Procedures and deadlines for licensing import of medicinal materials without
the marketing authorization in Vietnam other than controlled medicinal
materials; import of reference materials and primary packages of drugs
1. Procedures and deadlines for
licensing import of medicinal materials, primary packages of drugs and
reference materials specified in Articles 82, 84, 86 and 87 hereof:
a) The applicant shall submit an
application to the Ministry of Health directly or by post;
b) After receiving the application,
the Ministry of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
c) If the application is
satisfactory, the Ministry of Health shall issue the import license within 15
working days from the day on which the application is received;
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dd) After receiving the
supplemented application, the Ministry of Health shall give the applicant form
No. 01 in Appendix I enclosed herewith. If the application is still
unsatisfactory, the Ministry of Health shall request the applicant to complete
it in accordance with Point d this Article. If the supplemented application is
satisfactory, the Ministry of Health shall issue the import license in
accordance with Point c of this Clause;
e) Within 06 months from the day on
which additional documents are requested in writing by the Ministry of Health,
the applicant shall submit additional documents as requested. If the applicant
fails to satisfy such request by the aforementioned deadline or the application
is not satisfactory within 12 months from the first time it is submitted, the
application will be rejected.
2. In the cases of import of
medicinal materials specified in Article 85 hereof:
a) The applicant shall submit an
application to the Ministry of Health directly or by post;
b) After receiving the application,
the Ministry of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
c) If the application is
satisfactory, the Ministry of Health shall issue the import license within 03
working days from the day on which the application is received;
d) If the application is not
satisfactory, the Ministry of Health shall request the applicant in writing to
complete it within 03 working days from the day on which it is received;
dd) After receiving the
supplemented application, the Ministry of Health shall give the applicant form
No. 01 in Appendix I enclosed herewith. If the application is still
unsatisfactory, the Ministry of Health shall request the applicant to complete
it in accordance with Point d this Article. If the supplemented application is
satisfactory, the Ministry of Health shall issue the import license in
accordance with Point c of this Clause.
3. The specimens of the import
license and permission to import medicinal materials are provided in Form No.
44 or Form No. 45 in Appendix III enclosed herewith.
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Article 89.
Effective periods of the license to export drugs/medicinal materials and the
license to import drugs/medicinal materials
1. Effective periods of licenses to
export drugs/medicinal materials:
a) A license to export
drugs/medicinal materials issued according to Articles 57, 59, 60, 62 and
Clause 1 Article 61 hereof is effective for up to 01 year;
b) A license to export
drugs/medicinal materials issued according to Articles 58 and Clause 8 Article
64 hereof is effective for up to 02 years;
2. Effective periods of licenses
and written permissions to import drugs/medicinal materials:
a) A license or written permission
to import drugs is effective for up to 01 year;
b) A license to import narcotic
drugs, psychotropic drugs, precursor drugs, medicinal materials that are
narcotic active ingredients, psychotropic active ingredients or drug precursors
is effective for up to 01 year and expires after the import is completed;
c) A license or written permission
to import medicinal materials other than those mentioned in Point b of this
Clause is effective for up to 02 years.
3. The effective period of a
license or permission must be specified therein.
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1. Minimum remaining shelf life of
imported modern drugs, herbal drugs, traditional drugs, medicinal materials
other than those specified in Clause 3 of this Article when customs clearance
is granted:
a) 18 months if the official shelf
life is longer than 24 months;
b) 1/2 of the official shelf life
if it does not exceed 24 months;
2. The minimum remaining shelf life
of imported vaccines and biologicals other than those specified in Clause 3 of
this Article when customs clearance is granted is 1/2 of the official shelf
life.
3. Imported drugs/medicinal
materials specified in Articles 67, 73, 74, 75, 82, 83, 84, 85, 86 and Clause
1b Article 68 hereof must be unexpired when customs clearance is granted.
4. The Minister of Health shall
consider permitting import of drugs/medicinal materials whose remaining shelf
life is shorter than those specified in Clause 1 or Clause 2 of this Article
but they are essential for prevention and treatment of diseases.
5. An application for the
permission to import a drug/medicinal material mentioned in Clause 4 of this
Article consists of:
a) The importer’s written request
which specifies: name of the drug/medicinal material, remaining shelf life when
customs clearance is granted and explanation as to why its remaining shelf life
is shorter than those specified in Clause 1 or Clause 2 of this Article;
b) Documents proving that the
remaining shelf life of the batch of drug/medicinal material when customs clearance
is granted is shorter than those specified in Clause 1 or Clause 2 of this
Article.
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a) The applicant shall submit an
application to the Ministry of Health directly or by post;
b) After receiving the application,
the Ministry of Health shall give the applicant form No. 01 in Appendix I
enclosed herewith;
c) If the application is
satisfactory, the Ministry of Health shall issue the written permission to
import within 15 working days from the day on which the application is
received;
d) If the application is not
satisfactory, the Ministry of Health shall request the applicant in writing to
complete it within 15 working days from the day on which it is received;
dd) After receiving the
supplemented application, the Ministry of Health shall give the applicant form
No. 01 in Appendix I enclosed herewith. If the application is still
unsatisfactory, the Ministry of Health shall request the applicant to complete
it in accordance with Point d this Article. If the supplemented application is
satisfactory, the Ministry of Health shall issue the written permission to
import in accordance with Point c of this Clause;
e) Within 03 months from the day on
which additional documents are requested in writing by the Ministry of Health,
the applicant shall submit additional documents as requested. If the applicant
fails to satisfy such request by the aforementioned deadline or the application
is not satisfactory within 04 months from the first time it is submitted, the
application will be rejected.
Article 91.
Import of drugs and medicinal materials
1.186 Medicinal materials that are active ingredients,
excipients, capsule shells, semi-finished drugs, semi-finished herbal materials
that have not been registered for marketing authorization and are used for
production of drugs that have been registered for drug marketing authorization
in Vietnam shall be declared on website of registration authority using Form
No. 46 under Appendix III attached to this Decree within 15 days from the date
on which drug marketing authorization is issued or extended in Vietnam.
Medicinal materials on the List of medicinal materials permitted for import
shall not be required to be register for import permit other than medicinal
materials under special control.
2. The list of drugs and medicinal
materials banned from import and production is provided in Appendix V hereof.
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4. Institutions providing medical
or pharmaceutical training, drug testing laboratories and drug research
institutions may import drugs, medicinal materials and reference materials to
serve their operation.
5.187 Representative offices in Vietnam of manufacturers,
holders of the marketing authorization of drugs undergoing clinical trial,
bioavailability study or bioequivalence study; providers of clinical trial,
bioavailability study or bioequivalence study services may import medicinal
materials, primary packages of drugs and reference materials for provision of
the aforesaid services and register for the license to perform testing and
research on drugs and medicinal materials.
5a.188 The following agencies and organizations, which satisfy
the requirements in Article 35 of the Law on Pharmacy, may:
a. Import drugs which are specified
in Article 67 hereof, if assigned by the Ministry of National Defense, Ministry
of Public Security or Ministry of Health in a written request.
b) Import drugs as emergency aid or
humanitarian aid, if approved by the regulatory agency.
6. Traders may import primary
packages of drugs.
7. Drugs and medicinal materials
may only be imported through international checkpoints, except for
non-commercial import of drugs specified in Article 75 hereof.
8. The Minister of Health shall
decide the quantity of drugs/medicinal materials licensed for import as
follows:
a)189 The licensed import quantity of drugs that contains an
active ingredient that is not granted the marketing authorization or a herbal
material that is used in Vietnam for the first time specified in Article 65
hereof depends on the developments of the fatal disease, sexually transmitted
disease or dangerous and new epidemic;
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c) The licensed import quantity of
drugs serving urgent need for national defense and security, epidemic control
or disaster relief specified in Article 67 hereof depends on their purposes;
d) The licensed import quantity of
rare drugs specified in Article 69 hereof depends on the importer’s business
plan;
dd) The licensed import quantity of
drugs that have the same trade name, active ingredients, concentration and
dosage form as those of a original brand-name drug having the marketing
authorization in Vietnam, are manufactured by the same manufacturer of the
original brand-name drug or by an authorized manufacturer and are sold at a
lower price than that of the original brand-name drug sold in Vietnam as
specified in Article 70 hereof depends on the possibility of achieving the
price stabilization target;
e) The licensed import quantity of
drugs serving a health program of the State specified in Article 71 hereof
depends on the need for drugs of such program;
g) The licensed import quantity of
drugs as emergency aid or humanitarian aid specified in Article 72 hereof
depends on the recipient’s need;
h) The licensed import quantity of
drugs imported for the purpose of clinical trial, bioequivalence study,
bioavailability assessment, testing or scientific research specified in Article
73 hereof depends on the approved research outline of the laboratory’s need;
i) The licensed quantity of drugs
imported for non-commercial purposes specified in Article 75 hereof depends on
the owner’s need for disease treatment;
k) The licensed import quantity of
controlled drugs specified in Articles 79 and 80 hereof depends on the importer’s
business plan;
l) The licensed import quantity of
reference materials, primary packages of drugs, medicinal materials without the
marketing authorization in Vietnam specified in Articles 82, 84, 85, 86 and 87
hereof depends on the importer’s need, except controlled drugs.
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10. The entities that are entitled
to import but not entitled to distribute drugs and medicinal materials in
Vietnam must do activities related to distribution of drugs and medicinal
materials in Vietnam except for drugs and medicinal materials they manufacture
in Vietnam, including:
a) Selling drugs and medicinal
materials, delivery drugs and medicinal materials to health facilities,
retailers, individuals and organizations other than wholesalers of drugs and
medicinal materials;
b) Receiving orders or payments for
drugs and medicinal materials from health facilities, retailers, individuals
and organizations other than wholesalers of drugs and medicinal materials;
c) Providing drug/medicinal
material transport or storage services;
d) Impose prices for drugs or
medicinal materials distributed by other pharmaceutical-trading establishment;
dd) Deciding the strategy or policy
on selling drugs/medicinal materials distributed by other
pharmaceutical-trading establishment;
e) Developing the plan for supply
of drugs and medicinal materials of health facilities in Vietnam;
g) Provide financial assistance for
buyers of drugs/medicinal materials to control the distribution of imported
drugs and medicinal materials;
h) Other activities related to drug
distribution defined by law.
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12. The importer that is not
entitled to distribute drugs and medicinal materials in Vietnam shall notify
the Ministry of Health in writing before it starts to sell or stops selling
drugs to a wholesaler that distributes the drugs or medicinal materials it
imported.
Within 03 days from the day on
which the importer’s notification is received, the Ministry of Health shall
publish information about the wholesaler on its website.
13. The import of herbal materials
that are specimens of a species on the list of endangered species for testing
or pharmaceutical research shall comply with regulations of law on
biodiversity.
14. Testing certificate of the
batch of imported drugs/medicinal materials:
a) The testing certificate shall be
written in Vietnamese or English language. If it is written in a language other
than Vietnamese or English language, a notarized Vietnamese or English
translation shall be included;
b) If a batch is manufactured by
more than one facilities, it is required to have the testing certificate of the
final manufacturing or releasing facility;
c) The testing certificate shall
contain: name and address of the manufacturing facility, testing certificate
number, name and signature of the responsible for person, date of issue of the
testing certificate, product name, batch number, shelf life, applied quality
standards and requirements, testing results, conclusion.
15.190 To be allowed to sign a contract with an
importer, the foreign supplier of drugs/medicinal materials must be:
a) A manufacturer of imported
drugs/medicinal materials;
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c) The applicant for registration
of the drug or medicinal material has the marketing authorization in Vietnam
which does not expire at the time customs clearance is granted. This applicant
must be other than those mentioned in Points a and b of this Clause.
d) An establishment granted the
License to trade drugs, medicinal materials, vaccines, biologicals or
ingredients thereof in Vietnam;
dd) In cases specified in Points c,
d or h of this clause, they are required to be authorized in writing by the
entity mentioned in Point a or b of this Clause to supply drugs in Vietnam.
Except for those specified in points d and h of this clause, they are specified
in point a or b of this clause.
The authorization document may be
an authorization letter, seller's license or certificate of partnership. The
authorization document must be written in Vietnamese or English and contain:
name and address of the authorizing party and authorized party; scope of supply
of drugs/medicinal materials in Vietnam; authorization period or sale period;
responsibilities of the parties for the quality and origins of drugs/medicinal
materials supplied in Vietnam; signatures of the parties;
e) Regulations of this Clause do
not apply to suppliers of imported drugs specified in Articles 67, 73 and
Clause 1, Article 74 hereof.
g) Regulations of Point dd of this
Clause do not apply to suppliers of imported drugs specified in Articles 68 and
70 hereof.
h) Establishments specified in
Clause 22 hereof;
16.191 Regulations of Clause 15 of this Article do not apply
to suppliers of imported excipients, capsule shells, primary packages of drugs,
reference materials and medicinal materials used for producing controlled drugs
which are imported for testing, research or production of exported drugs
according to Article 80 hereof; medicinal materials used for producing imported
drugs according to Articles 82, 83, 84, 85 hereof; drugs as emergency aid or
humanitarian aid.
17. The license to import drugs
shall be revoked in the following cases:
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b) The marketing authorization of
the imported drug is revoked by the competent authority of the manufacturing
country, member state of the ICH or Australia;
c) A competent authority concludes
that fraudulent documents are used in the application for licensing drug
import;
d) The location where the imported
drug is manufactured is not consistent with the address on the application for
licensing drug import;
dd) The drug contains an imported
active ingredient or herbal material that is not recommended by WHO, a
competent authority of Vietnam or the country of origin;
e) The manufacturer or importer
requests revocation of the license;
g) A pharmacy authority of the
exporting country issues a request for recall of the imported batch.
18. The license to import medicinal
materials shall be revoked in the following cases:
a) The medicinal material is
recalled according to Clause 2a, 2b, 2d, 2dd or 2e Article 62 of the Law on
Pharmacy;
b) The imported active ingredient
or herbal material is not recommended by WHO, a competent authority of Vietnam
or the country of origin of the active ingredient or herbal material.
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a) Any of the violations mentioned
in Clause 17a, 17c and 17d of this Article is committed;
b) Within 12 months, 02 or more
batches of the imported drug are recalled because of second-degree violations
specified in Clause 2b Article 63 of the Law on Pharmacy or 03 or more batches
of the imported drug fails to meet quality standards;
c) Information in the application
for the import license is not based on research findings or the manufacturer’s
capacity;
d) Information about the efficacy
and safety of the imported drug is not updated on its label or package insert
as requested by the Ministry of Health.
20. The entire batch of drug or
medicinal material shall be suspended from import if its manufacturer:
a) commits a serious violations
against GMP requirements as prescribed by the Minister of Health;
b) produces 02 or more batches that
constitute first-degree violations specified in Clause 2a Article 63 of the Law
on Pharmacy within 12 months;
c) produces 03 or more batches that
constitute second-degree violations specified in Clause 2b Article 63 of the
Law on Pharmacy within 12 months or produces 04 or more batches that fail to
meet quality standards;
d) The duration of suspension shall
be 01 – 02 years for the violations mentioned in Points a and b of this Clause;
06 – 12 months for the violations mentioned in Point c of this Clause.
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a) Within 10 days from the date of
import of a vaccine that is already granted the marketing authorization in
Vietnam or a drug that is not granted a marketing authorization in Vietnam, the
importer shall submit a report on each shipment to the Ministry of Health and
National Institute for Control of Vaccines and Biologicals (for vaccines)
according to Form No. 47 or Form No. 48 in Appendix III enclosed herewith.
b) By the 15th of July
and 15th of January, the importer shall prepare biannual and annual
reports on import of drugs and medicinal materials according to Form No. 49 or
Form No. 50 in Appendix II enclosed herewith and send them to the Ministry of
Health.
22.192 If the Ministry of Health receives a written document
from the competent authority of the exporting country requesting the
announcement of the list of manufacturers and sellers which register for
supplying drugs and medicinal materials in Vietnam, the Ministry of Health
shall:
a) Within 30 days from the date on
which the written request of the aforesaid competent authority is received, the
Ministry of Health shall post the list of foreign manufacturers and sellers
which register for supplying drugs and medicinal materials in Vietnam on its
website.
b) If the Ministry of Health
receives the written document from the aforesaid authority requesting it to
change the announced information about the foreign suppliers, the Ministry of
Health shall implement point a of this clause.
23.193 The competent authority of the exporting country
specified in clause 23 of this Article shall send a written notification to the
Ministry of Health as follows:
a) The written notification must be
sent within 01 month, from the date on which the written request for changes to
the name, address and business scope of the supplier is received.
b) The written notification must be
sent within 15 days from the date on which the document about the termination
or suspension imposing to the foreign suppliers in its home country is
received.
24.194 The written documents of the competent authority
specified in clauses 23 and 24 hereof must:
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b) Be the original copies which are
written in English or Vietnamese. If the copies cannot be written in English or
Vietnamese, provide the certified translated documents in one of these
languages.
Article 92.
Documents to be produced and submitted upon customs clearance of drugs and
medicinal materials
Apart from the documents to be
submitted according to regulations of law on customs, the following documents
shall be produced and submitted upon customs clearance of drugs and medicinal
materials:
1. Regarding export of drugs and
medicinal materials:
a) A copy of the Certificate of
eligibility for pharmacy business which bears the exporter’s seal if the
exporter is a pharmacy business establishment (the original copy or certified
true copy shall be produced for comparison);
b) A copy of the export license
which bears the exporter’s seal and the original copy or certified true copy
thereof for comparison in case of export of herbal materials on the list of
controlled precious, rare and endemic medicinal material species and varieties;
controlled drugs except for those in Point c of this Clause;
c) Copies of the prescription and
outpatient's medical record which is authenticated or bears the applicant’s
signature (if the applicant is an individual) or seal (if the applicant is an
organization) if the drug is personal property shipped under a lading bill or
an outbound passenger’s belongings for his/her treatment and the quantity does
not exceed 07 days' dose if the drug is a narcotic drug; 10 days if the drug is
a psychotropic drug or precursor drug; 30 days if the drug is a combination
drug that contains a narcotic active ingredient, a combination drug that
contains a psychotropic active ingredient or a combination drug that contains a
precursor, toxic drug or a drug on the list of drugs, an active ingredient on
the list of substances banned from certain fields according to the dose written
on the accompanying prescription.
2.195 Regarding import of drugs and medicinal materials
having marketing authorization in Vietnam, medicinal materials on the list of
active ingredients, excipients, capsule shells, semi-finished products,
semi-finished medicinal materials used for drug production having marketing
authorization in Vietnam, except for herbal materials:
a) A copy of the Certificate of
eligibility for pharmacy business which bears the importer’s seal if the
importer is a pharmacy business establishment (the original copy or certified
true copy shall be produced for comparison;
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c) The original copy or a copy
bearing the importer’s seal of the testing certificate of each batch of
imported drug or medicinal material (the original copy must be produced for
comparison if a copy is submitted);
d)196 A copy bearing the importer’s seal of the authorization
letter or the seller’s license or certificate of partnership according to
Clause 15dd Article 91 hereof, except for import of excipients, capsule shells,
drugs as emergency aid or humanitarian aid;
dd)197 In case of import of a drug or medicinal material
specified in Clause 1dd, Article 59 of the Law on Pharmacy and such case does
not require the import license, the importer shall provide the bill of lading
in order to prove that the shipment is sent from the exporting country's port
before the expiration date of the marketing authorization to be granted customs
clearance.
e)198 In case of import of a drug or medicinal material
specified in Clause 1dd, Article 59 of the Law on Pharmacy and if such case
does not require the import license, the importer shall provide the bill of
lading to prove that the shipment is sent from the exporting country’s port
before the expiration date of the marketing authorization to be granted customs
clearance;
g)199 In case of import of medicinal materials specified in
the list of active ingredients, excipients, semi-finished drugs used for
production of drugs that are granted the marketing authorization in Vietnam and
if such case does not require the import license, the importer shall provide
the bill of lading to prove that the shipment is sent from the exporting
country’s port before the expiration date of the marketing authorization which
is used to declare the expired materials (if such certificate is used to
declare the expired materials during customs clearance);
h)200 In case of import of medicinal materials specified in
the list of active ingredients, excipients, semi-finished drugs used for
production of drugs that are granted the marketing authorization in Vietnam and
if such case does not require the import license, the importer shall provide
the bill of lading to prove that the shipment is sent from the exporting
country’s port before the expiration date of the marketing authorization used
to declare the expired materials and the import license (if such certificate
and license expire by the time of customs clearance).
3.201 Regarding import of herbal materials and semi-finished
herbal materials with or without marketing authorization in Vietnam, other than
semi-finished herbal materials for manufacturing drugs with marketing
authorization in Vietnam:
a) A copy bearing the importer’s
seal of the Certificate of eligibility for pharmacy business if the importer is
a pharmacy business establishment (the original copy or certified true copy
shall be produced for comparison);
b) Regarding herbal materials and
semi-finished herbal materials having the marketing authorization in Vietnam, a
copy of the marketing authorization bearing the importer’s seal (the original
copy or certified true copy shall be produced for comparison);
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d) A copy bearing the importer’s
seal of the manufacturer’s document authorizing the foreign exporter to export
herbal materials or semi-finished herbal materials, unless the manufacturer is
also the exporter. The content of such document is specified in Clause 15dd
Article 91 hereof;
dd) The original copy or a copy
bearing the manufacturer’s seal of the testing certificate of each batch of the
imported herbal material or semi-finished herbal materials (the original copy
must be produced for comparison if a copy is submitted);
e)202 In case of import of medicinal materials and
semi-finished medicinal materials specified in Clause 1dd, Article 59 hereof
and if such case does not require the import license, the importer shall
provide the bill of lading in order to prove that the shipment is sent from the
exporting country's port before the expiration date of the marketing
authorization;
g) In case of import of herbal
materials and semi-finished herbal materials specified in Article 82 and
Article 83 hereof, the documents specified in Points b, d, dd and e of this
Clause are not required.
h)203 In case of import of medicinal materials and
semi-finished medicinal materials specified in Clause 1dd, Article 59 of the
Law on Pharmacy and if such case does not require the import license, the
importer shall provide the bill of lading in order to prove that the shipment
is sent from the exporting country's port before the expiration date of the
marketing authorization and the Import License to be granted customs clearance;
i)204 In case of import of medicinal materials and
semi-finished products in the form of import license but without a marketing
authorization in Vietnam and such import license expires by the time of customs
clearance, the importer shall provide the bill of lading in order to prove that
the shipment is sent from the exporting country's port before the expiration
date of the Import License to be granted customs clearance.
4.205 Regarding import of drugs or medicinal materials
without marketing authorization in Vietnam, other than cases specified in
Clause 2 and Clause 3 of this Article:
a) A copy of the Certificate of
eligibility for pharmacy business which bears the importer’s seal if the
importer is a pharmacy business establishment (the original copy or certified
true copy shall be produced for comparison;
b) A copy of the import license
bearing the importer’s seal (the original copy or a certified true copy shall
be produced for comparison);
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d) Copies of the prescription and
outpatient's medical record which is authenticated or bears the applicant’s
signature (if the applicant is an individual) or seal (if the applicant is an
organization) in any of the following cases:
The quantity of drugs to be
imported does not exceed 07 days’ dose for narcotic drugs or 10 days’ dose for
psychotropic drugs and precursor drugs according to the prescription;
The drug is not a narcotic drug,
psychotropic drug or precursor drug, the total customs value of a shipment does
not exceed USD 200 according to the inter-bank exchange rate on the customs
clearance date and not more than 03 shipments are received by an organization
or individual in a year. If the drug is used for treatment of a disease on the
list of fatal diseases in the Government's Decree No. 134/2016/ND-CP , the customs
value of a shipment must not exceed VND 10,000,000 and not more than 04
shipments are received by an individual in a year.
The original copies the
prescription and outpatient's medical record shall be produced upon customs
clearance for comparison with the copies submitted.
dd)207 A copy bearing the importer’s seal of the authorization
letter or the seller’s license or certificate of partnership according to
Clause 15dd Article 91 hereof, except for import of drugs specified in Articles
67, 68, 70, 72 and 73 and Clause 1 Article 74 hereof, primary packages of
drugs, reference materials, controlled medicinal materials imported for drug
production according to Article 80 hereof, medicinal materials granted the
import license according to Articles 82, 83, 84, 85 and 86 hereof, controlled
medicinal materials that are imported for testing or research.
e)208 In case of import of drugs, medicinal materials in the
form of import license but without a marketing authorization in Vietnam and
such import license expires by the time of customs clearance, the importer
shall provide the bill of lading in order to prove that the shipment is sent
from the exporting country’s port before the expiration date of the Import
License to be granted customs clearance.
Chapter V
MARKETING AUTHORIZATION OF HERBAL MATERIALS,
EXCIPIENTS, CAPSULE SHELLS AND ASSESSMENT OF OVERSEAS DRUG MANUFACTURERS
Section 1.
MARKETING AUTHORIZATION OF HERBAL MATERIALS, EXCIPIENTS, CAPSULE SHELLS
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1. Marketing authorization must be
obtained for an herbal material in any of the following cases before it is
marketed in Vietnam:
a)209 (repealed)
b) it is used as a medicinal
material in Vietnam for the first time;
c)210 (repealed)
d)211 (repealed)
dd)212 It is on the list of herbal materials that can be
domestically obtained with adequate quantity for the treatment demand and at
reasonable prices;
e)213 Semi-finished herbal materials, unless these
semi-finished herbal materials are produced by the same facilities in order to
produce finished drugs or semi-finished herbal materials for producing drugs
with marketing authorization in Vietnam, semi-finished products for testing,
research, or production of export drugs.
2. Applied standards of herbal
materials other than those specified in Clause 1 of this Article shall be
declared in accordance with Clause 2 Article 68 of the Law on Pharmacy.
Procedures for marketing authorization are specified in Section 1 of Chapter V
hereof
3.214 In the cases where quality standards applied to an
excipient that are established by the manufacturer are not included in
Vietnam’s pharmacopoeia or any Vietnam’s pharmaceutical standards or any
foreign pharmacopoeia specified by the Minister of Health, marketing
authorization must be obtained for such excipient, unless the excipient is used
for manufacturing of drugs with effective marketing authorization in Vietnam
and the excipient is used for testing, research, or manufacturing of drugs for
export. Procedures for marketing authorization shall conform to Section 1
Chapter V of this Decree.
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5. The following entities may apply
for marketing authorization of herbal materials, excipients or capsule shells:
a) The establishments specified in
Clause 3 Article 54 of the Law on Pharmacy;
b) The establishments specified in
Clause 1c Article 35 of the Law on Pharmacy that are permitted to apply for
marketing authorization of herbal materials.
6. Marketing authorization method,
rights and obligations of applicants for marketing authorization of herbal
materials, excipients and capsule shells are specified in Article 55 and
Article 57 of the Law on Pharmacy
Article 94.
Power, documents, procedures and deadline for issuing, renewing, adjusting and
revoking the marketing authorization of herbal materials, excipients and
capsule shells
The power, documents, procedures
and deadline for issuing, renewing, adjusting and revoking the marketing
authorization of herbal materials, excipients and capsule shells are specified
in Article 56 and Article 58 of the Law on Pharmacy, with the following
exceptions:
1. If the applicant is an herbal
material collection facility without the Certificate of eligibility for
pharmacy business, a certified true copy of the certificate of enterprise
registration shall be included in the application.
2. The marketing authorization of
herbal materials, excipients and capsule shells shall be issued within 06
months from the day on which the satisfactory application is received.
Section 2.
INSPECTION OF FULFILLMENT OF GMP REQUIREMENTS BY OVERSEAS MANUFACTURERS OF
DRUGS/MEDICINAL MATERIALS WHEN THEY APPLY FOR REGISTRATION IN VIETNAM
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1. If a drug or medicinal material
has not been granted a marketing authorization, the applicant shall submit an
application for GMP inspection in addition to the application for the marketing
authorization of the drug or medicinal material in the following cases:
a) The foreign manufacturer applies
for drug granted marketing authorization in Vietnam for the first time;
b) The production line of the drug
has not undergone inspection by the Ministry of Health;
c) The medicinal material is an
active ingredient that is granted marketing authorization in Vietnam for the
first time;
d) The foreign manufacturer applies
for herbal material marketing authorization in Vietnam for the first time.
2. If the marketing authorization
of a drug or medicinal material is issued before the effective date of this
Decree and its manufacturer has not undergone inspection by the Ministry of
Health, an application GMP inspection shall be submitted when:
a) applying for renewal of the
marketing authorization of the drug or medicinal material according to Clause 4
Article 55 of the Law on Pharmacy;
b) applying for issuance of the
marketing authorization of the drug or medicinal material because of relocation
of the factory according to Clause 2b or Clause 2c Article 55 of the Law on
Pharmacy.
3. If the drug or medicinal
material is manufactured by multiple factories, the applicant shall apply for
inspection of all of the factories that participate in the production.
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1. Inspection of documents about
the manufacturing conditions shall be carried out in the cases specified in
Clause 2 and Clause 3b of this Article.
2. The inspection result given by a
pharmacy authority shall be recognized in the following cases:
a) The manufacturer is of a country
that has agreement with Vietnam on mutual recognition of GMP inspections
according to the list compiled by the Ministry of Health, except for the cases
specified in Clause 3 of this Article;
b) The manufacturer is of a member
state of ICH or Australia, undergoes GMP inspection and granted the certificate
of GMP by either US Food and Drug Administration (USFDA), European Union,
European Medicines Agency (EMA), Australia’s Therapeutic Goods Administration
(TGA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) or Health
Canada, except for the cases specified in Clause 3 of this Article.
3. A site inspection shall be
carried out when:
a) The application for registration
of drug or medicinal material is suspected of falsification or inaccuracy;
b) The manufacturer commits a
first-degree violation according to conclusion of the Ministry of Health;
c) The Ministry of Health concludes
that documents submitted by the manufacturer are not sufficient for proving its
fulfillment of GMP requirements.
d)216 The manufacturer of drugs and medicinal materials of
the exporting country fails to apply Good Manufacturing Practice principles,
standards promulgated, applied, or recognized by the Minister of Health in
accordance with Point c Clause 1 Article 97 hereof.
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1. Documents that are basis for
inspection:
a) The GMP requirements applied to
drugs and medicinal materials prescribed by the Minister of Health;
b) Effective regulations on
registration of drugs and medicinal materials and quality control.
c)217 If GMP principles and standards do not fall under any
of the principles and standards promulgated or declared by the Minister of
Health in accordance with Point a Clause 1 of this Article, authorization
advisory council shall evaluate conformity of principles, standards of
exporting countries relative to principles, standards of the Minister of
Health. Once conformity assessment results are produced, the Minister of Health
shall issue decision recognizing conformity of GMP principles, standards of
exporting countries in order to assess manufacturing facilities.
2. Document inspection contents:
a) Legitimacy of the certificate of
GMP, the manufacturing license or the report on GMP inspection;
b) Suitability of the certificate
of GMP, the manufacturing license or the report on GMP inspection for the
dosage form of the registered drug or medicinal material;
c) Suitability of the factory,
including the floor plan, production line, building materials, environmental
conditions, movement of employees, materials, semi-finished products and
finished products, movement of equipment for manufacturing, testing, storing
drugs/medicinal materials;
d) Establishment and operation of
the manufacturer’s quality control system;
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3. Contents of inspection in the
form of mutual recognition of GMP inspection by foreign pharmacy authorities:
a) Legitimacy of the certificate of
GMP, the manufacturing license or the report on GMP inspection;
b) Suitability of the certificate
of GMP, the manufacturing license or the report on GMP inspection for the
dosage form of the registered drug or medicinal material.
4. Contents of site inspection:
a) Legitimacy of the certificate of
GMP, the manufacturing license or the report on GMP inspection;
b) Conditions of the factory,
including the floor plan, production line, building materials, environmental
conditions, movement of employees, materials, semi-finished products and
finished products, movement of equipment for manufacturing, testing, storing
drugs/medicinal materials;
c) Operation of the production line
for the drug or medicinal material registered;
d) Establishment and operation of
the manufacturer’s quality control system;
dd) Application of GMP requirements
to the production, testing, storage of drugs/medicinal materials by the
manufacturer.
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1. The application for GMP
inspection submitted by a manufacturer of drugs/medicinal materials that are
active ingredients in any of the cases specified in Clause 2 Article 96 hereof
consists of:
a) The certificate of GMP, the
manufacturing license or the report on GMP inspection which contains sufficient
information about the dosage form of the drug or medicinal material issued by a
competent authority of the manufacturer’s home country;
b) The site master file (SMF)
prepared by the manufacturer according to instructions of EU, Pharmaceutical
Inspection Co-operation Scheme (PIC/S) or WHO.
2. The application for GMP inspection
submitted by a manufacturer of drugs/medicinal materials that are active
ingredients in any of the cases specified in Clause 1 and Clause 3 Article 96
hereof consists of:
a) The certificate of GMP, the
manufacturing license or the report on GMP inspection which contains sufficient
information about the dosage form of the drug or medicinal material issued by a
competent authority of the manufacturer’s home country; the certificate of GMP
or report on GMP inspection issued by the pharmacy authority of a member state
of EU or PIC/S (if any);
b) The SMF prepared by the
manufacturer according to instructions of EU, Pharmaceutical Inspection
Co-operation Scheme (PIC/S) or WHO;
c) A list of GMP inspections
carried out by pharmacy authorities of the manufacturer’s home country over the
last 03 years before the application is submitted and the report on the latest
GMP inspection that involves the registered drug or medicinal material or the
dosage form thereof;
d)218 (repealed)
dd)219 (repealed)
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3. The application for GMP
inspection submitted by a manufacturer of excipients or capsule shells consists
of:
a) The certificate of GMP, the
manufacturing license or the report on GMP inspection which contains sufficient
information about the excipient of capsule shells issued by a competent
authority of the manufacturer’s home country;
b)220 (repealed)
c)221 (repealed)
4. The application for GMP
inspection submitted by a manufacturer of herbal materials consists of:
a) The certificate of GMP or the
report on GMP inspection;
b) The quality handbook according
to ISO/TR 10013:2001 of updates thereof or the SMF prepared by the manufacturer
according to instructions of EU, PIC/S or WHO;
c)222 (repealed)
d) Documents about the area(s)
where herbal materials have been exported or intended for export to Vietnam are
obtained;
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5. An application for GMP
inspection shall satisfy the following requirements:
a) The application is written in
English or Vietnam language; documents in the application are clearly printed
and arranged in the order specified in Clause 1 through 4 of this Article, the
parts are clearly separated; the application has covers and a list of
documents;
b)223 The certificate of GMP and report on GMP inspection
mentioned in Clause 1 through 4 of this Article and the manufacturing license
mentioned in Clause 1 through 3 of this Article must be original copies or
certified true copies and must be unexpired when the application is submitted.
If the expiration date is not specified, they must be issued within the last 03
years, from the date on which the application is submitted
The Certificate of GMP or the
Manufacturing License are not required if they are posted on the website of the
pharmacy authority.
Article 99.
Receipt of applications and time of inspection
1. The Ministry of Health shall
receive applications for GMP inspection, carry out the inspections, prepare GMP
inspection reports and notify the results:
a)224 Within 20 days from the date on which the satisfactory
application is received in case of mutual recognition of GMP inspection;
b)225 Within 40 days from the date on which the satisfactory
application is received in case of document inspection;
c) within 90 days from the day on
which the satisfactory application is received in the case specified in Clause
3b Article 96 of this Decree or the date of notification of the result of
verification of the application for drug registration or application for GMP
inspection and the plan for site inspection in the cases specified in Clause 3a
and Clause 3c Article 96 of this Decree.
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3. If the certificate of GMP or the
manufacturing license is expired on the inspection date or the report on GMP
inspection was issued more than 03 years before the inspection date or the SMF
does not contain sufficient information, the Ministry of Health shall request
the applicant to complete the application.
a) The supplementary SMF shall be
submitted within 90 days, the certificate of GMP, manufacturing license or GMP
inspection report within 06 months;
b) The Ministry of Health shall
notify the applicant of the result within 30 days from the day on which
supplementary documents are received.
4. Within 10 working days from the
day on which the result is available, the Ministry of Health shall publish
information about the inspected and recognized manufacturers on its website.
Article 100.
Responsibilities of applicants for registration of drugs/medicinal materials of
foreign manufacturers in GMP inspection; cases in which applications for
marketing authorization of drugs/medicinal materials are rejected
1. During the GMP inspection, the
applicant for registration of a drug or medicinal material of a foreign
manufacturer shall:
a) Submit the application for GMP
inspection as prescribed;
b) Take responsibility for the
adequacy and accuracy of documents in the application for GMP inspection;
provide supporting documents requested by the Ministry of Health;
c) Cooperate with the manufacturer
in complying with requests of the Ministry of Health;
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d) Pay the cost of GMP inspection as
prescribed by law.
2. The application for issuance or
renewal of the certificate of drug/medicinal material registration shall be
rejected if the applicant or the manufacturer commits any of the following
violations:
a)226 Any of the violations that result in revocation of the
marketing authorization of drug/medicinal material specified in Points a, d and
dd Clause 1 Article 58 of the Law on Pharmacy;
b) Materials of unknown origins or
expired materials are used for drug production;
c) At least 02 batches of drug or
medicinal material fail to meet Level 2 quality standards or at least 03
batches of drug or medicinal material fail to meet quality standards within 01
years according to conclusion given by a competent authority;
d) Information about technical
documents is provided without research or production in reality;
dd) No report is submitted to the
Ministry of Health within 15 days from the day on which a competent authority
of the manufacturer’s home country issues a notification of revocation of the
manufacturing license or the manufacturer’s failure to meet GMP requirements;
e) Shelf life of drug is falsified,
except for the case specified in Clause 3 Article 61 of the Law on Pharmacy;
g) No report is submitted to the
Ministry of Health within 15 days from the day on which a competent authority
issues a notification that the registered drug or medicinal material is
recalled or has the marketing authorization revoked in any country in the
world;
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3. From the day on which the
violation is notified by a competent authority, the applicant shall be
suspended from submitting the application for issuance or renewal of the
marketing authorization of drug/medicinal material;
a) 03 – 05 years in the cases
specified in Clause 1d Article 58 of the Law on Pharmacy;
b) 01 – 02 years in the cases
specified in Clause 1a and 1 dd Article 58 of the Law on Pharmacy and Points b,
c, d, dd and e of Clause 2 of this Article;
c)228 06 months – 01 year in the cases specified in Clause 1b
Article 58 of the Law on Pharmacy and Clause 2g of this Article.
4.229 Applications submitted by applicants that commit any of
the violations specified in Points a, b, d, dd, e, Clause 2 of this Article
before the violations are dealt with will be invalidated. At the end of the
periods specified in Clause 3 of this Article, the application may be submitted
in accordance with the Law on Pharmacy.
Chapter VI
RECALL OF MEDICINAL MATERIALS AND HANDLING OF RECALLED
MEDICINAL MATERIALS
Article 101.
Types and scale of recall
1. Types of recall:
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b) Voluntary recall: by the
applicant for registration, manufacturer or importer of medicinal materials.
2. Scale of recall:
a) Medicinal materials shall be
recalled from establishments that sell or use them, except for the case in
Point b of this Clause;
b) If the material fails to meet
quality standards because of an error during the process of storage, transport
or distribution, or used for unintended purposes, only the affected materials
at establishments that sell or use it shall be recalled;
c) The scale of recall must be
specified in the decision on recall issued by the competent authority (in case
of mandatory recall) or by the applicant for registration, the manufacturer or
the importer (in case of voluntary recall).
Article 102.
The power to recall and procedures for recalling medicinal materials
1. Power to issue the decision on
recall:
a) The Ministry of Health shall
decide the recall of medicinal materials and issue the decision on recall in
case of mandatory recall;
b) Domestic manufacturers and
importers of medicinal materials shall decide the recall of medicinal materials
and issue the decision on recall in case of voluntary recall.
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a) Within 48 hours from the time a
recall is decided, the Ministry of Health or the establishment mentioned in
Clause 1b of this Article shall issue the decision on recall and inform the
Ministry of Health of the recall. Decision on mandatory recall shall be sent to
domestic manufacturers of medicinal materials, importers of medicinal
materials, Departments of Health of provinces and posted on the website of the
Ministry of Health;
b) Within 05 working days from the
day on which the decision on recall is issued, the domestic manufacturer or
importer of medicinal materials inform buyers of the materials of the recall
and organize receipt of the materials returned;
c) The recall of medicinal
materials must be finished within 30 days from the day on which the decision on
recall is issued;
d) Within 10 days from the day on
which the recall is finished, the establishment responsible for the recall shall
submit a report to the Ministry of Health which is enclosed with copies of the
documents about the recall bearing the establishment’s seal. Documents about
the recall are documents that specify quantity of materials manufactured or
imported, quantity of materials recalled, time of manufacture, date of import,
list of buyers and evidence that materials have been returned by the buyers and
users;
dd) The Ministry of Health shall
verify the report, assess the effectiveness of the recall or enforce the recall
if the domestic manufacturer or importer fails to carry out the recall in
accordance with Point b or Point c of this Clause.
Article 103.
Responsibility to recall medicinal materials
1. The domestic manufacturer or
importer of the recalled medicinal material shall:
a) Give a conclusion that the
material has to be recalled and issue a decision on recall in case of voluntary
recall;
b) Stop selling the recalled
material;
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d) Handle the recalled material;
dd) Pay for the recall and handling
of recalled material (even if the recall is enforced) and pay damages as
prescribed by law;
e) Submit a report on the recall to
the Ministry of Health.
2. Each distributor of the recalled
material shall:
a) Stop buying and selling the
recalled material;
b) Return the material to its
supplier.
c) Return the material to its
supplier;
d) Pay for the recall and handling
of recalled material (even if the recall is enforced) and pay damages if the
distributor is at fault.
3. The manufacturer that uses the
recalled material shall:
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b) Return the material to its
supplier.
4. The Ministry of Health shall:
a) Draw a conclusion that the
medicinal material has to be recall and issue the decision on recall in case of
mandatory recall;
b) Verify the report on recall and
comment on the handling and recycling of the recalled material;
c) Inspect and supervise the
recall; take actions against violators as prescribed by law;
d) Instruct the Department of
Health of the province to inspect and supervise recall of medicinal materials
and take actions against violators in its province;
dd) Decide enforcement of recall if
the domestic manufacturer or importer fails to carry out the recall as
requested;
e) Publish information about the
recalled medicinal materials on its website if they have to be destroyed.
5. The Department of Health of the
province shall:
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b) Inspect and supervise recall of
medicinal materials and take actions against violators in the province;
c) Inform the Ministry of Health of
the establishments that fail to properly recall medicinal materials.
Article 104.
Handling recalled materials
1. Recalled medicinal materials
that are herbal materials or active ingredients shall be destroyed in the
following cases:
a) The medicinal materials are not
meant for human use but labeled for human use;
b) The marketing authorization was
obtained by submission of fraudulent documents;
c) The origin of the materials is
unknown;
d) The active ingredient is
displayed or labeled under another manufacturer or manufacturing country or
country of origin;
dd) The herbal material is
counterfeit;
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g) The medicinal materials are used
to produce drugs that are not recommended by WHO.
2. Medicinal materials may be
recycled in the following cases:
a) The medicinal materials are
recalled because they fail to comply with regulations on labels or medicinal
materials specified in Article 61 of the Law on Pharmacy or relevant
regulations of law;
b) The medicinal materials are
recalled because they are produced at factory other than the registered factory
but the former is granted a manufacturing license by a competent authority.
3. Recalled medicinal materials
that are not psychotropic active ingredients, narcotic substances, drug
precursors and are not those mentioned in Clause 1 and Clause 2 of this Article
may be recycled if they are domestically produced or re-exported if they are
imported or repurposed under the procedures in Clause 4 of this Article.
Recalled medicinal materials that
are not recycled, re-exported or repurposed shall be destroyed.
4. Procedures for remedying,
recycling230 and repurposing
medicinal materials:
a) A written request for permission
to repurpose, remedy or recycle231
the medicinal materials which specifies the new purposes, the remedies or the
recycling process shall be sent to the Ministry of Health;
b) The remedy or recycling232 of medicinal materials must
not be carried without the consent of the Ministry of Health;
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5. Procedures for destroying
medicinal materials:
a) The head of the establishment
whose medicinal materials have to be destroyed shall establish a medicinal
material destruction council. The council consists of at least 03 persons,
including the head and the chief pharmacist of the establishment;
b) The destruction of medicinal
materials must ensure long-term health of human and animals and avoid causing
environmental pollution in accordance with regulations of law on environmental
protection;
c) The establishment having the
recalled medicinal materials shall pay for their destruction;
d) Destruction of controlled
medicinal materials shall comply with regulations of Article 48 of this Decree.
Chapter VII
CERTIFICATION OF DRUG INFORMATION AND DRUG
ADVERTISEMENTS
Section 1.
CERTIFICATION OF DRUG INFORMATION
Article 105. Methods of provision of drug information 234
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1. Provision of drug information
via “Sale representatives”.
2. Publishing of documents
containing drug information.
3. Holding pharmaceutical
conferences.
Article 106.
Applicants for certification of drug information
1. The following entities may apply
for certification of drug information:
a) Establishments applying for drug
registration in Vietnam;
b) Representative offices in
Vietnam authorized by the overseas establishments that apply for drug
registration in Vietnam;
c) Vietnamese pharmacy business
establishments authorized by the establishments mentioned in Clause 1a of this
Article;
d) Vietnamese drug importers, which
may only provide information about the drugs they import using the method
specified in Clause 3 Article 105 of this Decree.
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Article 107. Cases in which the Certification of Drug
Information is required 235
1. The certification of drug
information shall be issued in the following cases:
a) The certification of drug
information is applied for the first time;
b) The certification of drug
information was issued but the applicant for drug registration, drug name,
ingredients, concentration, dosage form, indications, contraindications,
dosage, uses for special cases, warnings or drug safety information is changed.
2.236 (repealed)
3.237 (repealed)
Article 108.
Application for the certification of drug information
1. An application for the
certification of drug information which is provided using the method mentioned
in Clause 2 Article 105 of this Decree consists of:
a) Form No. 01 in Appendix VI
enclosed herewith;
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c) Specimens of the label and
package insert approved by the Ministry of Health;
d) Reference documents about the
drug information to be certified (if any);
dd)238 (repealed)
e)239 The license for establishment of a representative
office in Vietnam if the applicant is a foreign establishment; or the Certificate
of Eligibility for Drug Business if the applicant is a Vietnamese pharmacy
business establishment. The Certificate of Eligibility for Drug Business is not
required if the applicant is a Vietnamese pharmacy business establishment.
g) In case the applicant for
certification of drug information is authorized by the applicant for drug
registration, the authorization document.
2. An application for the
certification of drug information which is provided using the method mentioned
in Clause 3 Article 105 of this Decree consists of:
a) Form No. 02 in Appendix VI
enclosed herewith;
b) Drug information;
c) Specimens of the label and
package insert approved by the Ministry of Health;
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dd)240 (repealed)
e)241 The license for establishment of a representative
office in Vietnam if the applicant is a foreign establishment; or the
Certificate of Eligibility for Drug Business if the applicant is a Vietnamese
pharmacy business establishment. The Certificate of Eligibility for Drug
Business is not required if the applicant is a Vietnamese pharmacy business
establishment.
g) In case the applicant for
certification of drug information is authorized by the applicant for drug
registration, the authorization document;
h) The agenda of the pharmaceutical
conference.
Article 109.242 (repealed)
Article 110.243 (repealed)
Article 111. Documents included in the application for
issuance of the Certification of Drug Information 244
1. Documents mentioned in Clause
1c, Clause 1dd, Clause 2c and Clause 2dd of Article 108 shall be copies.
2.245 Documents mentioned in Clause 1d, Clause 1e, Clause 2d,
Clause 2e of Article 108 shall be copies bearing the seal of the applicant if
they are issued by the Minister of Health or certified true copies if they are
not issued by the Ministry of Health.
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4.246 (repealed)
5.247 Documents mentioned in Clause 1b and Clause 2b of
Article 108 hereof are original copies and made into 02 copies.
6.248 Each application for issuance of the Certification of
Drug Information shall contain:
a) 01 specimen of the design
mentioned in Clause 1 Article 108 of this Decree or 01 sheet of drug
information mentioned in Clause 2 Article 108 of this Decree for a drug;
b) 01 specimen of the design
mentioned in Clause 1 Article 108 of this Decree or 01 sheet of drug
information mentioned in Clause 2 Article 108 of this Decree for more than one
drug that have the same active ingredients and route of administration, the
same manufacturer but different concentrations or dosage forms.
7. Documents shall be printed on A4
paper sheets and bear fan stamping of the applicant for the certification of drug
information.
Article 112.
Presentation of drug information
1. Drug information shall satisfy
the following requirements:
a) Information is sufficient
according to Clause 5a Article 76 of the Law on Pharmacy; information and
images not related to the drug or use of the drug and similar information and
images specified in Article 126 of this Decree are not permitted;
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c) The drug information is written
in Vietnamese language, except for untranslatable information;
d) Minimum font size: 12; Font:
VnTime or Times New Roman; Page: A4.
2. The text “Tài liệu thông tin
thuốc” (“Drug information”) must be displayed on the top of all pages. Pages of
a multi-page document must be numbered. The first page must contain the table
of content and the text “Số Giấy xác nhận nội dung thông tin thuốc của Bộ Y
tế…/XNTT/…, ngày ... tháng ... năm ...” (“Number and date of the certification
of drug information issued by the Ministry of Health: …”).
3. In case of a pharmaceutical
conference, the drug information must include the names and academic ranks of
the speakers, whose medical or pharmaceutical qualifications are suitable for
the drug introduced.
Article 113.
Procedures for issuance of the certification of drug information
1. The applicant shall submit the
application for the certification of drug information to the competent
authority specified in Article 116 of this Decree.
2.249 Within 10 days from the date on which the satisfactory
application is received, the receiving authority shall issue the Certificate to
the applicant by using Form No. 05 or Form No.06 in Appendix hereto. If the
application is rejected, the receiving authority must respond and provide
explanation in writing.
3.250 If the application is not satisfactory, within 10 days
from the date on which the application is received, the receiving authority
shall request the applicant in writing to complete the application. To be
specific:
a) The written request shall
specify necessary adjustments and/or additions;
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c) Within 90 days from the date on
which the additional documents are requested in writing by the receiving
authority, the applicant shall submit additional documents as requested.
Otherwise, the application will be rejected.
4. While the application is being
processed, the receiving authority shall suspend granting the confirmation and
issue a notification of the suspension if the information about drug safety and
efficacy in the package insert is found unsatisfactory or not updated as
requested by competent authority or according to instructions given or
recognized by the Ministry of Health. The suspension will be lifted when the
applicant submits adjusted or updated information that ensures safety of drug
users.
5. At least 03 working days before
providing drug information using the method mentioned in Clause 3 Article 105
of this Decree, the holder of the certification of drug information shall send
a notification of the time and location and a copy of the certification of drug
information to the Department of Health of the province where drug information
is provided.
If the time or location is changed,
the Department of Health shall be informed at least 01 (one) working day before
drug information is provided.
6. The application will be rejected
if the applicant, including authorized applicants mentioned in Clause 1b and
Clause 1c Article 106 of this Decree, commits any of the following violations:
a) Legal documents issued by
regulatory authorities in the application for certification of drug information
are falsified or forged;
b) The drug information is provided
or the drug advertisement is run before its contents are certified by a
competent authority or against the contents certified by a competent authority;
c) A certificate not recognized by
the Ministry of Health, another organization’s or individual’s name, symbol,
images, letters or reputation is included in the drug information or
advertisement.
d) A clinical trial result,
pre-clinical trial result, test result or bioequivalence study result not
recognized by the Ministry of Health is included in the drug information or
advertisement;
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7. From the day on which the
violation is notified by a competent authority, the applicant shall be
suspended from submitting the application for the certification of drug
information or drug advertisement for:
a) 01 – 02 years in the cases
specified in Clause 6a of this Article;
b) 06 – 12 months in the cases
specified in Clause 6b, Clause 6c or Clause 6d of this Article;
c) 03 – 06 months in the cases
specified in Clause 6dd of this Article.
Article 114.252 (repealed)
Article 115.253 (repealed)
Article 116. Power to issue the Certification of Drug
Information 254
1. The Ministry of Health has the
power to issue the Certification of Drug Information in cases specified in
clause 2, Article 105 hereof.
2. Departments of Health of
provinces have the power to issue the Certification of Drug Information in
cases specified in Clause 3, Article 105 hereof.
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1. The certification of drug
information is effective nationwide.
2. The certification of drug
information does not have a specific expiration date and shall be invalidated
in the following cases:
a) The marketing authorization or
the license for drug import is revoked;
b) A change to drug information is
made that requires issuance of another certification of drug information
according to Clause 1b Article 107 of this Decree.
Section 2.
CONFIRMATION OF DRUG ADVERTISEMENT CONTENTS
Article 118.
Means of advertising drugs
Drugs may be advertised through the
means of advertising defined by advertising laws.
Article 119.
Applicants for confirmation of drug advertisement contents
1. The following entities may apply
for confirmation of drug advertisement contents:
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b) Representative offices in
Vietnam authorized by the overseas establishments that apply for drug
registration in Vietnam;
c) Vietnamese pharmacy business
establishments authorized by the establishments mentioned in Clause 1a of this
Article.
2. Applicants for drug
registration, including those authorizing the entities mentioned in Clause 1b
or 1c of this Article to apply for confirmation of drug advertisement contents,
shall take responsibility for the drug advertisement contents.
Article 120. Issuance of the certification of drug
advertisement contents 255
1. The certification of drug
advertisement contents shall be issued in the following cases:
a) The certification of drug
advertisement contents is applied for the first time;
b) The certification of drug
advertisement contents was issued but the applicant for drug registration, drug
name, ingredients, concentration, dosage form, indications, contraindications,
dosage, uses for special cases, warnings or drug safety information is changed.
2.256 (repealed)
3.257 (repealed)
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1. An application for the
certification of drug advertisement contents, except for advertisements in the
form of conferences, conventions or events, consists of:
a) Form No. 01 in Appendix VI
enclosed herewith;
b) The graphic design of the drug
advertisement; the audio or video track of the advertisement on audio or video
news and other means of audio and video advertisements defined by advertising
laws;
c) Specimens of the label and
package insert approved by the Ministry of Health;
d) Reference documents about the
drug advertisement contents to be certified (if any);
dd)258 (repealed)
e)259 The license for establishment of a representative
office in Vietnam if the applicant is a foreign establishment; or the
Certificate of Eligibility for Pharmacy Business if the applicant is a
Vietnamese pharmacy business establishment. The Certificate of Eligibility for
Pharmacy Business is not required if the applicant is a Vietnamese pharmacy
business establishment.
g) In case the applicant for the
confirmation of drug advertisement contents is authorized by the applicant for
drug registration, the authorization document.
2. An application for the
certification of contents of drug advertisement in the form of a conference,
convention or event consists of:
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b) The drug advertisement contents;
c) Specimens of the label and
package insert approved by the Ministry of Health;
d) Reference documents about the
drug advertisement contents to be certified (if any);
dd)260 (repealed)
e)261 The license for establishment of a representative
office in Vietnam if the applicant is a foreign establishment; the certificate of
eligibility for drug business if the applicant is a Vietnamese pharmacy
business establishment. The Certificate of Eligibility for Pharmacy Business is
not required if the applicant is a Vietnamese pharmacy business establishment.
g) In case the applicant for the
confirmation of drug advertisement contents is authorized by the applicant for
drug registration, the authorization document;
h) The expected agenda of the
conference, convention or event.
Article 122.262 (repealed)
Article 123.263 (repealed)
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1. Documents mentioned in Clause
1c, Clause 1dd, Clause 2c and Clause 2dd of Article 121 shall be copies.
2.265 Documents mentioned in Clause 1d, Clause 1e, Clause 2d,
Clause 2e of Article 121 must be copies which bear the seal of the applicant if
they are issued by the Ministry of Health or certified true copies if they are
not issued by such Ministry.
3. Documents mentioned in Clause 1g
and Clause 2g of Article 121 of this Decree shall be original copies or
certified true copies.
4.266 (repealed)
5.267 Documents mentioned in Clause 1b and Clause 2b of
Article 121 and Clause 2 of Article 122 of this Decree are 02 original copies.
6.268 Each application for issuance of the certification of
drug advertisement contents shall contain:
a) 01 specimen of the graphic
design or audio track or video track of the advertisement mentioned in Clause 1
Article 121 of this Decree or 01 specimen of the drug advertisement mentioned
in Clause 2 Article 121 of this Decree for a drug;
b) 01 specimen of the graphic
design or audio track or video track of the advertisement mentioned in Clause 1
Article 121 of this Decree or 01 specimen of the drug advertisement mentioned
in Clause 2 Article 121 of this Decree for more than one drug that have the
same active ingredients and route of administration, the same manufacturer but
different concentrations or dosage forms;
7. The documents shall be printed
on A4 papers. In case of advertisements on billboards, the drug advertisement
contents may be printed on an A3 paper with specific ratio. All documents in
the application must bear the applicant’s seal across the margins of
consecutive pages. If the advertisement object is three-dimensional, a
description on A3 paper with the following information shall be included:
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b) Numbers and dimensions of the
sides;
c) The ratio of the specimen to the
real object.
Article 125.
Requirements applied to drug advertisement contents
1. The drug advertisement contents
shall comply with the following documents:
a) The label and package insert
approved by the Ministry of Health;
b) The treatise on the drug in the
National Pharmacopoeia of Vietnam;
c) Related instructions provided or
recognized by the Ministry of Health.
2. The drug advertisement contents
have the following compulsory information:
a) Drug name;
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c) Indications;
d) Uses;
dd) Dosage;
e) Contraindications and warnings
for special users (pregnant women, breast-feeding women, children, old people,
people having chronic diseases);
g) Cautions and what to avoid when
using the drug;
h) Side effects and adverse
effects;
i) Name and address of the
manufacturer;
k) The text “Đọc kỹ hướng dẫn sử
dụng trước khi dùng" (“Read the instructions carefully before use”);
l) The text “Số Giấy xác nhận nội
dung quảng cáo thuốc của Bộ Y tế: .../XNQC..., ngày ... tháng ... năm...;”
(“Number and date of the certification of drug advertisement contents issued by
the Ministry of Health: …”) at the end of the first page;
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n) Reference documents and extracts
therefrom are specified. The extracts must be accurate without addition or
removal of information which leads to misunderstanding of the safety and
efficacy of the drug.
3. The contents of an audio or
video advertisement must contains sufficient information specified in Points a,
b, c, e, i, k Clause 2 of this Article. Information mentioned in Points a, b,
c, e, k Clause 2 of this Article must be read aloud. If the drug
consists of 03 or more active ingredients, each of them or the groups of
vitamins, minerals and herbal materials must be read aloud.
4. Contents of advertisements on
online newspapers, websites, electronic devices, advertising screens and other
means of advertising defined by advertising laws:
a) The contents of an advertisement
that has sounds shall comply with regulations of Clause 3 of this Article;
b) The contents of an advertisement
without sounds shall comply with regulations of Clause 2 of this Article.
If the advertisement is an audio or
video track that has multiple pages or footages, the pages or footages must be
continuous and stay still for viewers to read all information; the page or
footage that contains product information must be still for viewers to read
such information. The script must specify how the pages of a multi-page
advertisement are shown.
Such an advertisement must not
advertise more than one drugs to avoid confusion.
5. The contents of an outdoor
advertisement shall be shown on one side of the board and contains the
information specified in Points a, b, i, k, l Clause 2 of this Article If the
advertisement contains information about the effects and indications of the
drug, sufficient information specified in Clause 2 of this Article must be
provided.
6. Voice and text in a drug
advertisement shall comply with the Law on Advertising.
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8. The script must clearly describe
the graphics, dialogues, text and music.
9. A drug advertisement may only
provide information about the drug and may not provide information not related
to the drug.
Article 126.
Information and images banned from drug advertisements
1. Information and images
prescribed in the Law on Advertising.
2. Information that causes
misunderstanding about the ingredients, effects, indications or origin of the
drug.
3. Information causing the viewers
to believe that the drug is the best, the drug can be used without physician’s
counsel, the drug is completely harmful, the drug has no contraindications or
adverse effects.
4. Sentences, words and images
which are excessively deductive resulting in a misunderstanding about or an
overestimation of the approved effects, indications and efficacy of a drug.
5. Information that equates effects
of some ingredient of the drug with effects of the drug.
6. The following words and phrases:
“điều trị tận gốc”, “tiệt trừ”, “chuyên trị” (“complete treatment"), “hàng
đầu”, “đầu bảng”, “đầu tay” (“best”, “top”), “lựa chọn”, “chất lượng cao”
(“high-quality”), “đảm bảo 100%” (“100% guarantee”), “an toàn” (“safe”), “dứt”,
“cắt đứt”, “chặn đứng” (“stop”, “end”), “giảm ngay”, “giảm liền”, “giảm tức
thì” (“relieve instantly”), “khỏi ngay”, “khỏi hẳn” (“treat instantly”), “yên
tâm”, “không lo”, “khỏi lo” (”no worries”), “khuyên dùng” (“recommended”),
“hotline”, “điện thoại tư vấn” (“hotline”) and those with similar meanings.
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a) Treatment of tuberculosis or
leprosy;
b) Treatment of sexually
transmitted diseases;
c) Treatment of insomnia;
d) Aphrodisiac indications;
dd) Treatment of cancers or tumors;
e) Drug detoxification;
g) Treatment of diabetes mellitus
or similar metabolic disorders;
h) Treatment of viral hepatitis or
new dangerous diseases.
8. Drug or medicinal material
quality test results
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10. Clinical study results or
bioequivalence study results that have not been recognized by the Ministry of
Health.
11. Names, positions, letters of
other organizations or individuals used for advertising purposes.
12. Origin of the drug or medicinal
material used for advertising purposes.
13. Image, name or symbol of a
health worker.
14. Images of an animal or plant on
the list of priority protected endangered, precious and rare species.
15. Sentences and words that are
expressed as advice or tips that recommend the drug.
16. Images of patients used for
description of symptoms or effects of the drug that are not conformable with
relevant documents and instructions provided or recognized by the Ministry of
Health.
Article 121. Procedures for issuance of the
certification of drug advertisement contents 269
1. The applicant for the
certification of drug advertisement contents shall submit an application to the
Ministry of Health.
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Article 116. Power to issue the certification of drug
advertisement contents 270
The Ministry of Health has the
power to issue the certification of drug advertisement contents.
Article 129.
Effect of certification of drug advertisement contents
1. The certification of drug
advertisement contents does not have a specific expiration date and shall be
invalidated in the following cases:
a) The marketing authorization
expires;
b) The marketing authorization is
revoked;
c) A change to drug information is
made that requires issuance of another certification of drug advertisement
contents according to Clause 1b Article 120 of this Decree;
d) A regulatory body recommends
that the use of the drug should be restricted or supervised by medical
practitioners;
dd) The drug contains an active
ingredient or herbal material that has been removed from the list of OTC drugs
promulgated by the Minister of Health.
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Article 129a. Adjustment to the contents which are
granted the certification 271
1. If the information specified on
the Certification of Drug Information and Drug Advertisement is incorrect due
to the mistakes made by the issuer, the applicant must send a written
notification to the issuer and clearly specify the incorrect information that
requires to be modified. After receiving the written notification, the issuer
must send a written confirmation which specifies the contents to be adjusted to
the applicant. Such confirmation must be made by using form No. 07 in Appendix
VI hereto. The applicant may operate according to the adjusted contents and
shall be responsible for such contents.
2. If the amended contents are
granted the certification but this case is not specified in clause 1b, Article
107 or clause 1b, Article 120 of the Decree No. 54/2017/ND-CP , the applicant
shall notify the issuer of the adjusted contents in writing. The applicant may
change the contents themselves and shall be responsible for such changes.
Chapter VIII
MEASURES FOR DRUG PRICE MANAGEMENT
Section 1.
DECLARATION AND RE-DECLARATION OF DRUG PRICES
Article 130.
Declaration and re-declaration of drug prices
1. Declarations of drug prices
include:
a) The declaration of imported drug
prices according to Form No. 01 in Appendix VII enclosed herewith;
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2. Re-declarations of drug prices
include:
a) The re-declaration of imported
drug prices according to Form No. 03 in Appendix VII enclosed herewith;
b) The re-declaration of domestic
drug prices according to Form No. 04 in Appendix VII enclosed herewith.
3.272 The declaration of drug prices in case of change to the
marketing authorization specified in Clause 2b, Article 55 of the Law on
Pharmacy shall be made in accordance with clause 1 of this Article.
4. Documents to be submitted in
case of adjustment to information about a drug whose price has been declared or
re-declared while the drug price is not adjusted (except for the case in Clause
3 of this Article):
a) The information adjustment form
according to Form No. 05 in Appendix VII enclosed herewith;
b) 273 (repealed)
5. The documents shall be made into
02 sets, one of them shall be sent to the Ministry of Health or the People’s
Committee of the province in case of declaration of domestic drug prices, and
the other is retained by the declaring establishment.
6. Drug prices shall be expressed
in VND, inclusive of VAT. The unit price shall be the price for the smallest
pack.
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Article 131. Receipt
of declarations and re-declarations of drug prices, adjustment to declared and
re-declared drug prices, verification and announcement of declared and
re-declared drug prices
1. Regarding imported drugs:
a) The importer shall declare the
intended wholesale price and retail price for the imported drug (in case of
retailing) before launching the first shipment in Vietnam. Price declaration is
not required for the next shipments if the price declared is not adjusted;
b) The importer shall re-declare
the intended wholesale price and retail price if the price that was
declared/re-declared and posted on the website of the Ministry of Health is
increased.
c)274 A drug price declaration shall be submitted when the
marketing authorization specified in Clause 2b, Article 55 of the Law on
Pharmacy is adjusted, or the Drug Import License is also adjusted and before
the first shipment of imported drug is launched in Vietnam.
If adjustment is made to the
marketing authorization unspecified in Clause 2b, Article 55 of the Law on
Pharmacy or to the Drug Import License without adjusting the expected sale and
retail prices of the drug according to the declaration, the declarant is not
required to submit the declaration of drug prices but shall submit the
application specified in clause 4, Article 130 hereof.
d) During business operation, if
the importer decreases the wholesale price and retail price that was
declared/re-declared, the decreased price shall be re-declared.
2. Regarding domestic drugs:
a) The manufacturer or outsourcing
entity (in case of outsourcing manufacturing) shall declare the intended
wholesale price and retail price (in case of retailing) before launching the
first batch in Vietnam. Price declaration is not required for the next batches
if the price declared is not adjusted;
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c)275 A drug price declaration shall be submitted when the
marketing authorization specified in Clause 2b, Article 55 of the Law on
Pharmacy is adjusted and before the first batch of drugs is launched in
Vietnam.
If adjustment is made to the
marketing authorization unspecified in Clause 2b, Article 55 of the Law on
Pharmacy without adjusting the expected sale and retail prices of the drug
according to the declaration, the applicant is not required to submit the
declaration of drug prices but shall submit the application specified in clause
4, Article 130 hereof.
d) During business operation, if
the manufacturer or outsourcing entity (in case of outsourcing manufacturing)
decreases the wholesale price and retail price that was declared/re-declared,
the decreased price shall be re-declared.
3. Power to receive declarations
and re-declarations of drug prices:
a) The Ministry of Health shall
receive and verify declarations and re-declarations of imported drug prices,
declarations of domestic drug prices and declarations of adjustment to
information of drugs whose prices have been declared/re-declared;
b) The People’s Committees of
provinces shall receive and verify re-declarations of domestic drug prices from
establishments in their provinces.
4.276 Organization of receipt, verification and publishing of
declarations and re-declarations of drug prices:
a) The importer or outsourcing
entity (in case of outsourcing manufacturing) shall submit an application in
accordance with Clause 1 through 4 Article 130 of this Decree to the competent
authority specified in Clause 3 of this Article;
b)277 The receiving official shall examine the application
documents and their quantity if such application is completed. He/she shall
append a seal on the received documents, specify the date of receipt and return
01 dossier in person or by post to the applicant. If the Ministry of Health is
the receiving authority, such dossier must be enclosed with a receipt note,
using form No.06 in Appendix VII hereto. If the People’s Committees of
provinces and central-affiliated cities are the receiving authorities, the
receipt note must be made by using form No. 07 in Appendix VII hereto. Also,
the receiving official shall send 01 dossier to the heads of competent agencies
and technical service sections.
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c)278 Within 07 days from the date on which the complete
declarations which specify the declared/re-declared drug prices are received,
the Ministry of Health shall announce such declared/re-declared drug prices;
and additional drug information on its website;
d)279 As for the re-declarations of domestic drug prices:
- Within 03 working days from the
date on which the complete application is received, the People's Committees of
provinces and central-affiliated cities must send reports on the re-declared
drug prices to the Ministry of Health, using form No.08 in Appendix hereto
- Within 04 working days from the
date on which the reports from the People’s Committees of provinces and
central-affiliated cities are received, the Ministry of Health shall publish
the summarization of these reports on its website.
- After reviewing the prices, if
the People’s Committees of provinces and central affiliated cities request the
declaring establishment in writing to report about the declared prices which
are conformable with the changes of pricing elements, such establishment must
also send 01 report to the Ministry of Health.
dd) 280 (repealed)
e) 281 (repealed)
g) 282 (repealed)
Article 132.
Rights and responsibilities of drug pricing authorities in implementing
regulations on declaration and redeclaration of drug prices 283
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a) request pharmacy business
establishments making declarations in writing to produce reports on declaration
and redeclarations in conformity to declarations of similar commodities on the
market, fluctuations of price factors to serve price stabilization, price
management, examination, and inspection as per the law;
b) examine and inspect drug pricing
in pharmacy business establishments as per the law;
c) request competent authority to
take actions if pharmacy business establishments are found to: fail to declare
or redeclare; fail to adequately declare price prices or fail to adjust prices
and report at written request of competent drug pricing authority in respect of
declarations and redeclarations of enterprises; fail to adequately declare
price factors or sell drugs at a higher price than applicable declarations or
redeclarations;
d) consider measures taken if
pharmacy business establishments have committed at least 2 violations in a
year: temporarily suspend reception of request for verification of drug
information and advertising; temporarily suspend reception of request for
import of drugs without marketing authorization in Vietnam; temporarily suspend
reception of request for issuance, extension of drug, medicinal material
marketing authorization.
Temporary suspension under this
Point shall last for 03 months to 12 months from the date on which violate
notice is issued by competent authority.
2. Drug pricing authorities have
the responsibility to:
a) adhere to regulations on
receiving declarations and redeclarations in accordance with Article 131
hereof;
b) review declarations and
redeclarations of drug prices made by pharmacy business establishments in
accordance with Clause 1, Clause 2, Clause 4 Article 130 hereof;
c) maintain confidentiality of
declarations and redeclarations of organizations and individuals during the
period in which declarations and redeclarations of organizations and
individuals have not entered into effect as per the law.
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1. Pharmacy business establishments
have the right to:
Purchase, sell drugs at declared,
redeclared price from the date on which manufacturing facilities, processing
service buyers, importing facilities submit adequate declarations or
redeclarations to competent authority as per the law. Purchase, sell drugs at a
lower price while declaring price reduction if importing facilities,
manufacturing facilities, or processing service buyers lower declared price
relative to previous declarations.
2. Pharmacy business establishments
have the responsibility to:
a) adequately comply with
regulations on declaration and redeclaration of drug price, notify price in
accordance with regulations and this Decree; assume total legal responsibility
for accuracy and veracity of drug price declarations, redeclarations; produce
reports on declared, redeclared price at request of drug pricing authorities;
comply with examination and inspection of competent authority (if any);
b) not sell drugs in bulk or retail
drugs at a price higher than declared or redeclared price which has been
declared, redeclared by manufacturing facilities, processing service buyers,
importing facilities;
c) if competent authority request
pharmacy business establishments to produce reports on drug prices declared and
redeclared by the pharmacy business establishments, the pharmacy business
establishments shall respond in form of reports on declared prices conforming
to price level of similar products on the market or fluctuations of price
factors within 30 days from the date on which request of competent authority is
issued or adjust declared, redeclared prices in accordance with feedback of
drug pricing authority. If pharmacy business establishments fail to respond in
writing within the time limit above, submitted declarations and redeclarations
shall be voided;
d) comply with actions taken
against drug price declaration in accordance with regulations on administrative
penalties in prices, fees, charges, and invoices.
Article 134.
Review of published drug price declarations and redeclarations 285
1. Review of published drug price
declarations and redeclarations shall cover:
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b) Declared, redeclared drug prices
conforming to market price of similar drugs (if any).
2. If necessary, depending on
review contents under Clause 1 of this Article, drug pricing authorities shall
request Vietnam Social Security, pricing authorities, and relevant authorities
to permit post-inspection review of declared, redeclared drug prices.
Section 2.
LISTING OF DRUG PRICES, RETAIL SURPLUS APPLIED TO RETAILERS IN HEALTH
FACILITIES
Article 135.
Listing of drug prices
1. Responsibility to list drug
price:
a) Drug wholesalers shall list the
wholesale price of each drug at the wholesale stores;
b) Drug retailers shall list the
retail price of each drug at the retail stores;
c) Drug wholesalers and retailers
must not sell drugs at prices higher than listed prices.
2. Price listing:
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b) The retail price must be
printed, written or stuck on the primary package or secondary package of the
drug, written on a board or paper or in other forms as long as it does not
block the drug label, is suitable and noticeable by buyers and the authorities;
c) The listed currency shall be
VND;
d) The listed price shall be
inclusive of taxes and charges (if any).
Article 136.
Retail margins applied to retailers in health facilities
1. The retail price equals (=)
buying price according to the invoice plus (+) the retail margin percent rate
multiplied by (x) buying price. Formula:
Retail price equals = buying price
+ retail margin percent (%) x buying price.
2 286 The drug retailer within the premises of a health
facility may only buy drugs from suppliers that are awarded contracts for
supplying drugs to such health facility and drugs selected at the health
facilities in provinces and central-affiliated cities within 12 months; drugs
selected and procured in localities and nationwide within the term of the
contract or the centralized procurement framework before the procurement. The
buying prices are specified below:
a) The buying price for a drug on
the list of drugs supplied by successful bidders of the health facility must
not exceed the successful bid at the same time;
b) The buying price of a drug that
is not included in the list of drugs supplied by successful bidders of the
health facility must not exceed the successful bids at the health facilities in
provinces and central-affiliated cities within 12 months; the successful bids of
centralized procurements in localities and nationwide within the term of the
contract or according to the centralized procurement framework before the
procurement.
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3. Maximum retail margin percent
applied to drug retailers in health facilities:
a) If the buying price is not
exceeding 1,000 VND per smallest pack: 15%;
b) If the buying price is exceeding
VND 1,000 but not exceeding VND 5,000 per smallest pack: 10%;
c) If the buying price is exceeding
VND 5,000 but not exceeding VND 100,000 per smallest pack: 7%;
d) If the buying price is exceeding
VND 100,000 but not exceeding VND 1,000,000 per smallest pack: 5%;
dd) If the buying price is
exceeding VND 1,000,000 per smallest pack: 2%.
4. Definitions of smallest pack:
a) If the dosage form is tablets,
pills or capsules, the smallest pack is a tablet, pill or capsule;
b) If the dosage form is liquid,
the smallest pack is an ampoule, bottle, sachet or pre-filled syringe;
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dd) If the dosage form is orally
administered powder or granules, the smallest pack is a pack, bottle or sachet;
dd) If the dosage form is cream,
salve or gel for topical administration, the smallest pack is a tube or bottle;
e) If the dosage form is
transdermal patch, the smallest pack is a patch;
g) If the dosage form is a drug in
the form of spray or aerosol, the smallest package unit shall be spray bottle,
metered dose inhaler or drug jar of aerosol nebulizer;
h) If the dosage form is a kit, the
smallest pack is a kit.
Section 3.
BIDDING FOR DRUG PURCHASE, DRUG PRICE NEGOTIATION AND MEASURES FOR DRUG PRICE
STABILIZATION
Article 137.
Bidding for drug purchase
1. Bidding for drug purchase from
state capital, health insurance fund, revenue from provision of medical
services and other lawful sources of revenue of public health facilities shall
comply with regulations of law on bidding, the principles in Clause 4 Article 7
and Clause 6 Article 107 of the Law on Pharmacy.
2. Criteria for determination or
ration prices as the basis for promulgation of the list of domestic herbal
materials that can be domestically obtained with adequate quantity and at
rational prices:
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b) Fulfillment of Good Agricultural
and Collection Practices (GACP) by domestic manufacturer of traditional drugs
or herbal drugs; active ingredients of herbs and concentrations thereof.
3. The Minister of Health shall
provide guidelines for bidding for the drugs specified in Clause 1 and Clause 2
of this Article; publish the list of original brand-name drugs; promulgate
regulations on purchase of original brand-name drugs that are not on the list
of drugs and herbal materials eligible for price negotiation specified in
Article 138 of this Decree by selecting suitable contractors according to
bidding laws.
Article 138.
List of drugs and herbal materials eligible for price negotiation
The Minister of Health shall
promulgate the list of drugs and herbal materials eligible for price
negotiation according to Clause 6 Article 107 of herbal materials on the basis
of counsel of the National Advisory Council for Drug Bidding.
Article 139.
Drug price negotiation
Regulations of the Law on Pricing
and its instructional documents shall apply to implementation of measures for
drug price stabilization, power responsibility to implement of measures for
drug price stabilization.
Chapter IX
IMPLEMENTATION CLAUSES
Article 140.
Deadlines for obtaining the pharmacy practice certificate
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2.289 From January 01, 2021, every person in charge of
quality assurance of manufacturers of drugs and medicinal materials shall have
the pharmacy practice certificate.
3. From January 01, 2021, every
person in charge of clinical pharmacology of the hospitals specified in Clause
3 Article 116 of the Law on Pharmacy shall have the pharmacy practice
certificate.
4. From the effective date of this
Decree, every chief pharmacist of pharmacy business establishments290 of manufacturers of drugs or
medicinal materials shall have the practising certificate, except for the cases
specified in Clause 1 and Clause 2 of this Article.
5. Chief pharmacists of pharmacy
business establishments and owners of drug retailing stores who have been
granted the Certificate of eligibility for pharmacy business according to the
Law on Pharmacy No. 34/2005/QH11 shall keep holding the position of chief
pharmacist.
Article 141.
Deadlines for fulfillment of Good Practice requirements by pharmacy business
establishments
1. From the effective date of this
Decree, manufacturers of modern drugs, herbal drugs, vaccines or biologicals,
importers, exporters, wholesalers, retailers that are drugstores or
dispensaries, providers of testing services, storage services, bioequivalence
study services or clinical trial services, manufacturers of medicinal materials
that are sterile active ingredients shall fulfill corresponding Good Practice
requirements, except for the cases specified in Clause 2 and Clause 5 of this
Article.
2. From January 01, 2019,
manufacturers of medicinal materials that are active ingredients other than
sterile active ingredients mentioned in Clause 1 of this Article shall fulfill
GMP standards.
3. From the effective date of this
Decree, drug counters shall fulfill corresponding GPP requirements to be
granted the Certificate of eligibility for pharmacy business.
From July 01, 2019, drug counters
that have obtained the Certificate of eligibility for pharmacy business before
the effective date of this Decree shall fulfill corresponding GPP requirements.
By this deadline, the business conditions specified in the Certificate must be
maintained.
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From July 01, 2019, manufacturers
of orient drugs that have obtained the Certificate of eligibility for pharmacy
business before the effective date of this Decree shall fulfill GMP
requirements applied to traditional drugs. By this deadline, the business
conditions specified in the Certificate must be maintained.
5. From January 01, 2021,
manufacturers of excipients or capsule shells, manufacturers and processors of
herbal materials or prepared traditional medicinal materials shall meet
corresponding GMP requirements.
Article 142.
Deadlines for fulfillment of Good Practice requirements by non-commercial
pharmacy business establishments
1. From the effective date of this
Decree, non-commercial establishments specified in Clause 1a Article 35 of the
Law on Pharmacy that have not fulfilled Good Practice requirements may operate
within a scope corresponding to their fulfillment of Good Practice requirements
and have to fulfill all corresponding Good Practice requirements by the
following deadlines:
a) Establishments that store and
supply vaccines shall fulfill corresponding Good Practice requirements from
July 01, 2019;
b) Non-commercial pharmacy
establishments other than those mentioned in Point a of this Clause shall
fulfill corresponding Good Practice requirements from January 01, 2021.
2. From the effective date of this
Decree, non-commercial establishments specified in Clause 1a Article 35 of the
Law on Pharmacy that have just been inaugurated or changed its scope of
operation shall fulfill corresponding Good Practice requirements.
Article 143. Transition clauses 291
1. Applications submitted according
to regulations of the Law on Pharmacy No. 34/2005/QH11 and its instructional
documents shall apply regulations thereof, except for applications that are
submitted according to Clause 2 Article 115 of the Law on Pharmacy No.
105/2016/QH13 before the effective date of this Decree, unless the applicant
wishes to apply regulations of the Law on Pharmacy No. 105/2016/QH13.
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3.292 Licenses to export or import drugs/medicinal materials,
orders for exported or imported drugs/ medicinal materials and relevant
administration procedures shall be issued and carried out according to the Law
on Pharmacy No. 34/2005/QH11 and its instructional documents shall remain
effective until their expiration dates.
Drugs and medicinal materials
mentioned in this Clause are imported or exported and granted customs clearance
documents if they satisfy the requirements of the Law on Pharmacy No.
34/2005/QH11 and related instructional documents or according to this Decree,
from the date on which this Decree takes effect.
4. Drugs and medicinal materials
mentioned in this Clause are imported or exported and granted customs clearance
documents if they satisfy the requirements of the Law on Pharmacy No.
34/2005/QH11 and related instructional documents or according to this Decree,
from the date on which this Decree takes effect.
5. Establishments trading in
controlled drugs shall apply the following regulations:
a)293 An establishment trading in controlled drugs specified
in Clause 26a and Clause 26b Article 2 of the Law on Pharmacy may keep
operating until the end of June 30, 2018. After this day, it shall obtain the
Certificate of eligibility for pharmacy business that permits trading in
controlled drugs in accordance with Section 4 Chapter III of this Decree if it
wishes to keep operating;
b) An establishment trading in
controlled drugs specified in Clause 26c and Clause 26d Article 2 of the Law on
Pharmacy may keep operating until the expiration date written on its
Certificate of eligibility for pharmacy business or the Certificate of Good
Practice if the Certificate of eligibility for pharmacy business does not
specifies an expiration date. After this day, it shall obtain the Certificate
of eligibility for pharmacy business that permits trading in controlled drugs
in accordance with Section 4 Chapter III of this Decree if it wishes to keep
operating.
6. From July 01, 2018, retailers of
drugs on the list of drugs restricted from retailing shall comply with
regulations of Clause 2 Article 55 of this Decree.
7.294 From January 01, 2021, the marketing authorization or
declaration of applied standards shall be obtained in accordance with Clause 1
and Clause 2 Article 93 of this Decree before herbal materials are sold in
Vietnam.
8. From January 01, 2019, the
marketing authorization shall be obtained in accordance with Clause 4 Article
93 of this Decree before capsule shells are sold in Vietnam. From January 01,
2021, the marketing authorization shall be obtained in accordance with Clause 3
Article 93 of this Decree before excipients are sold in Vietnam.
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10. Certifications of drug
information and certifications of drug advertisement contents issued before the
effective date of this Decree shall remain effective until their expiration
dates.
11.295 A foreign enterprise whose license to trade
in drugs and medicinal materials in Vietnam or license to trade in vaccines,
biologicals and ingredients thereof in Vietnam is granted before the Decree No.
54/2017/ND-CP takes effect and is used until its expiry date.
12. From January 01, 2021,
medicinal materials that are excipients for production of drugs under an
application for registration of drugs having the marketing authorization in
Vietnam may be imported under a published list in accordance with regulations
of the Minister of Health without the import license.
Article 144. Effect 296
1. This Decree comes into force as
of July 01, 2017.
2. The following regulations and
documents are annulled:
a) Regulations on drug advertising
in Article 3 of the Government's Decree No. 181/2013/ND-CP ;
b) The Government's Decree No.
79/2006/ND-CP ;
c) The Government's Decree No.
89/2012/ND-CP ;
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3. In the cases where a legislative
document or regulation referred to in this Decree is changed or replaced, the
newer one shall apply.
Article 145. Responsibility for organization of
implementation of this Decree 297
1. The Minister of Health is
responsible for providing guidance and organizing the implementation of this
Decree.
2. Presidents of the People’s
Committees of provinces shall request Departments of Health to organize the
receipt and verification of re-declarations of prices of domestic drugs
submitted by establishments in their provinces.
3. Electronic declaration,
registration and application for licensing shall apply the roadmap established
by the Minister of Health.
4. Ministers, Heads of ministerial
agencies, Heads of Governmental agencies, Chairpersons of People’s Committees
of provinces are responsible for the implementation of this Decree./.
CERTIFIED
BY
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1 Preludes to the Government’s Decree No. 155/2018/ND-CP
dated November 12, 2018 on amendments to certain regulations relating to
business conditions under state management of the Ministry of Health, which has
been effective since November 12, 2018:
“The
Law on Government Organization dated June 19, 2015;
At the
request of the Minister of Health;
The
Government hereby promulgates a Decree on amendments to certain regulations
relating to business conditions under state management of the Ministry of
Health”.
Preludes
to the Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments
to Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health:
“The
Law on Government Organization dated June 19, 2015; Law on Amendments to some
Articles of the Law on Government Organization and Law on Local Government
Organization dated November 22, 2019;
The
Law on Pharmacy dated April 06, 2016;
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The
Government hereby promulgates a Decree on amendments to Decree
No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation
of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health.”.
2 This clause is amended by clause 1 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
3 This point is amended by clause 2 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
4 This point is repealed by clause 1 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
5 This point is repealed by clause 1 Article 4 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
6 This point is amended by clause 3 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
7 This point is repealed by clause 2 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
8 This point is amended by clause 4 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
9 This point is amended by point a clause 5 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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11 This Article is amended by clause 6 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
12 This Article is repealed by clause 3 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
13 This Article is repealed by clause 3 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
14 This Article is repealed by clause 3 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
15 This Article is repealed by clause 3 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
16 This Article is repealed by clause 3 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
17 This Article is repealed by clause 4 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
18 This Article is repealed by clause 4 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
19 This Article is repealed by clause 4 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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21 This point is amended by point b clause 7 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
22 This clause is repealed by clause 5 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
23 This clause is amended by clause 8 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
24 This clause is repealed by clause 7 Article 4 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
25 This Article is repealed by clause 8 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
26 This Article is repealed by clause 9 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
27 This Article is repealed by clause 10 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
28 This Article is repealed by clause 11 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
29 This clause is repealed by clause 12 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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31 This point is amended by point a clause 10 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
32 This point is amended by point b clause 10 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments
to regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
33 This point is amended by clause 11 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
34 The paragraph “Trường hợp cơ sở đề nghị cấp Giấy chứng
nhận đủ điều kiện kinh doanh với phạm vi xuất khẩu, nhập khẩu thuốc, nguyên
liệu làm thuốc có bán thuốc, nguyên liệu làm thuốc nhập khẩu cho cơ sở bán lẻ,
cơ sở khám bệnh, chữa bệnh thì phải có thêm tài liệu chuyên môn kỹ thuật và
nhân sự theo nguyên tắc Thực hành tốt phân phối thuốc, nguyên liệu làm thuốc”
(“If the applicant applies for a Certificate of eligibility for pharmacy
business that allows sale of drugs or medicinal materials imported to retailers
and health facilities, documents about technologies and personnel according to
GDP requirements applied to drugs and medicinal materials are required”) is
repealed as prescribed in clause 13 Article 4 of the Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 on amendments to regulations relating to
business conditions under state management of the Ministry of Health, which has
been effective since November 12, 2018.
35 This clause is repealed by clause 14 Article 4 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
36 The phrase "Sở Y tế nơi cơ sở đó đặt trụ sở"
("the Department of Health of the province where the applicant’s
headquarters is located") is replaced with the phrase "Sở Y tế nơi cơ
sở đó đặt địa điểm kinh doanh" ("the Department of Health of the
province where the applicant's business location exists") according to
clause 79 Article 5 of the Government’s Decree No. 155/2018/ND-CP dated
November 12, 2018 on amendments to regulations relating to business conditions
under state management of the Ministry of Health, which has been effective
since November 12, 2018.
37 Title of this clause is amended by clause 12 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
38 This point is amended by clause 12 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
39 This clause is amended by clause 12 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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41 This point is amended by clause 13 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
42 This clause is repealed by clause 15 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
43 This clause is repealed by clause 16 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
44 This clause is amended by clause 14 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
45 The paragraph “Ban hành danh mục thuốc, dược chất thuộc
danh mục chất bị cấm sử dụng trong một số ngành, lĩnh vực” (“Promulgation of
the List of drugs and active ingredients banned from certain fields”) is
changed into “Công bố danh mục thuốc, dược chất thuộc danh mục chất bị cấm sử
dụng trong một số ngành, lĩnh vực” (“Publication of the list of drugs and
active ingredients on the list of substances banned from certain fields”)
according to point a clause 15 Article 5 of the Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 on amendments to regulations relating to
business conditions under state management of the Ministry of Health, which has
been effective since November 12, 2018.
46 This point is amended by point b clause 15 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
47 This clause is amended by clause 16 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
48 The paragraph "có tường và trần kiên cố được làm từ
vật liệu chắc chắn" ("sturdy walls and ceiling") is repealed by
clause 18 Article 4 of the Government’s Decree No. 155/2018/ND-CP dated
November 12, 2018 on amendments to regulations relating to business conditions
under state management of the Ministry of Health, which has been effective
since November 12, 2018.
49 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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51 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP of the Ministry of Health, which has
been effective since November 12, 2018.
52 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
53 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
54 This point is amended by clause 17 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
55 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
56 The paragraph "có tường và trần kiên cố được làm từ
vật liệu chắc chắn" ("sturdy walls and ceiling") is repealed by
clause 18 Article 4 of the Government’s Decree No. 155/2018/ND-CP dated
November 12, 2018 on amendments to regulations relating to business conditions
under state management of the Ministry of Health, which has been effective
since November 12, 2018.
57 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
58 This clause is amended by clause 18 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
59 The paragraph "có tường và trần kiên cố được làm từ
vật liệu chắc chắn" ("sturdy walls and ceiling") is repealed by
clause 18 Article 4 of the Government’s Decree No. 155/2018/ND-CP dated
November 12, 2018 on amendments to regulations relating to business conditions
under state management of the Ministry of Health, which has been effective
since November 12, 2018.
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61 This point is amended by clause 19 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
62 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
63 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
64 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
65 This point is repealed by clause 17 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
66 This clause is amended by clause 20 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
67 The phrase “02 năm” (“02 years”) is changed into the phrase
“12 tháng” (“12 months”) according to clause 21 Article 5 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
68 The phrase “02 năm” (“02 years”) is changed into the
phrase “12 tháng” (“12 months”) according to clause 21 Article 5 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
69 This point is repealed by clause 19 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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71 The phrase “02 năm” (“02 years”) is changed into the phrase
“12 tháng” (“12 months”) according to clause 21 Article 5 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
72 This point is repealed by clause 19 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
73 This point is repealed by clause 19 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
74 The phrase “02 năm” (“02 years”) is changed into the phrase
“12 tháng” (“12 months”) according to clause 21 Article 5 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
75 This point is repealed by clause 19 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
76 This clause is repealed by clause 19 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
77 The phrase “02 năm” (“02 years”) is changed into the phrase
“12 tháng” (“12 months”) according to clause 21 Article 5 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
78 The phrase “02 năm” (“02 years”) is changed into the phrase
“12 tháng” (“12 months”) according to clause 21 Article 5 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
79 This point is repealed by clause 19 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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81 This clause is amended by clause 22 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
82 The phrase “02 năm” (“02 years”) is changed into the phrase
“12 tháng” (“12 months”) according to clause 21 Article 5 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
83 This point is repealed by clause 19 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
84 This point is
amended by clause 23 Article 5 of the Government’s Decree No. 155/2018/ND-CP
dated November 12, 2018 on amendments to regulations relating to business
conditions under state management of the Ministry of Health, which has been
effective since November 12, 2018.
85 This point is amended by clause 24 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
86 This point is amended by clause 25 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
87 This point is amended by clause 26 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
88 This point is amended by clause 27 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
89 This point is amended by clause 27 Article 5 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
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91 This point is amended by clause 29 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
92 This point is amended by clause 30 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
93 This clause is amended by clause 31 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
94 This clause is repealed by clause 20 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
95 This Article is repealed by clause 21 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
96 This Article is amended by clause 32 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
97 This Article is repealed by clause 22 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
98 This point is repealed by clause 23 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
99 This point is amended by point a clause 33 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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101 This point is amended by point a clause 34 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
102 This point is amended by point b clause 34 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
103 The phrase "Sở Y tế nơi cơ sở đó đặt trụ sở"
("the Department of Health of the province where the applicant’s
headquarters is located") is replaced with the phrase "Sở Y tế nơi cơ
sở đó đặt địa điểm kinh doanh" ("the Department of Health of the
province where the applicant's business location exists") according to
clause 79 Article 5 of the Government’s Decree No. 155/2018/ND-CP dated
November 12, 2018 on amendments to regulations relating to business conditions
under state management of the Ministry of Health, which has been effective since
November 12, 2018.
104 This point is repealed by clause 24 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
105 This point is repealed by clause 24 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
106 This point is repealed by clause 25 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
107 The phrase “c” is repealed by clause 25 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
108 This point is repealed by clause 25 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
109 This point is repealed by clause 25 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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111 This point is repealed by clause 26 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
112 This point is amended by point a clause 35 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
113 This point is amended by point a clause 35 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
114 This point is repealed by clause 27 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
115 This point is amended by point b clause 35 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
116 This point is amended by point b clause 35 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
117 The paragraph “thuốc trong Danh mục thuốc, dược chất thuộc
Danh mục chất bị cấm sử dụng trong một số ngành, lĩnh vực” (“a drug on the list
of drugs and active ingredients on the list of banned substances in certain
fields”) is repealed according to clause 28 Article 4 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
118 The paragraph "Miễn nộp tài liệu tại điểm này đối với
trường hợp cơ sở sản xuất đã được xác nhận đạt nguyên tắc, tiêu chuẩn thực hành
tốt sản xuất trên Giấy chứng nhận sản phẩm dược;" ("Documents
specified in this point are not required to be submitted if the manufacturer
has been certified conformable with GMP principles on the certificate of
pharmaceutical product;") is added by clause 29 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
119 This point is repealed by clause 27 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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121 This point is amended by clause 36 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
122 This point is amended by clause 36 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
123 The paragraph “thuốc trong Danh mục thuốc, dược chất thuộc
Danh mục chất bị cấm sử dụng trong một số ngành, lĩnh vực” (“a drug on the list
of drugs and active ingredients on the list of banned substances in certain
fields”) is repealed according to clause 28 Article 4 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
124 The paragraph "Miễn nộp tài liệu tại điểm này đối với
trường hợp cơ sở sản xuất đã được xác nhận đạt nguyên tắc, tiêu chuẩn thực hành
tốt sản xuất trên Giấy chứng nhận sản phẩm dược;" ("Documents
specified in this point are not required to be submitted if the manufacturer
has been certified conformable with GMP principles on the certificate of
pharmaceutical product;") is added by clause 29 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
126 This point is repealed by clause 30 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
126 This point is amended by clause 37 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
127 This point is repealed by clause 31 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
128 This point is amended by point a clause 35 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
129 This clause is repealed by clause 31 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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131 The phrase "sinh phẩm" ("biologicals")
is repealed by clause 32 Article 4 of the Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 on amendments to regulations relating to
business conditions under state management of the Ministry of Health, which has
been effective since November 12, 2018.
132 This point is amended by point c clause 38 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
133 This point is amended by clause 39 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
134 The paragraph “thuốc trong Danh mục thuốc, dược chất thuộc
Danh mục chất bị cấm sử dụng trong một số ngành, lĩnh vực” (“a drug on the list
of drugs and active ingredients on the list of banned substances in certain
fields”) is repealed according to clause 28 Article 4 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
135 The paragraph "Miễn nộp tài liệu tại điểm này đối với
trường hợp cơ sở sản xuất đã được xác nhận đạt nguyên tắc, tiêu chuẩn thực hành
tốt sản xuất trên Giấy chứng nhận sản phẩm dược;" ("Documents
specified in this point are not required to be submitted if the manufacturer
has been certified conformable with GMP principles on the certificate of
pharmaceutical product;") is added by clause 29 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
136 This point is repealed by clause 33 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
137 This point is repealed by clause 34 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
138 This point is amended by point a clause 40 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
139 This point is amended by point b clause 40 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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141 This point is amended by point b clause 40 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
142 The paragraph "Miễn nộp tài liệu tại điểm này đối với
trường hợp cơ sở sản xuất đã được xác nhận đạt nguyên tắc, tiêu chuẩn thực hành
tốt sản xuất trên Giấy chứng nhận sản phẩm dược;" ("Documents
specified in this point are not required to be submitted if the manufacturer
has been certified conformable with GMP principles on the certificate of
pharmaceutical product;") is added by clause 29 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
143 This point is repealed by clause 35 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
144 This clause is amended by point a clause 41 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
145 This point is amended by point b clause 41 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
146 This point is amended by point b clause 41 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
147 This point is amended by point b clause 41 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
148 This point is amended by point b clause 41 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
149 This point is amended by point b clause 41 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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151 The paragraph "Miễn nộp tài liệu tại điểm này đối với
trường hợp cơ sở sản xuất đã được xác nhận đạt nguyên tắc, tiêu chuẩn thực hành
tốt sản xuất trên Giấy chứng nhận sản phẩm dược;" ("Documents
specified in this point are not required to be submitted if the manufacturer
has been certified conformable with GMP principles on the certificate of
pharmaceutical product;") is added by clause 29 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
152 This point is amended by point b clause 41 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
153 This point is repealed by clause 36 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
154 This point is repealed by clause 37 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
155 This point is repealed by clause 38 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
156 This point is repealed by clause 38 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
157 The phrase “72” is repealed by clause 39 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
158 This point is repealed by clause 40 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
159 This point is amended by point a clause 42 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
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161 Title of this clause is amended by point b clause 42
Article 5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018
on amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
162 This point is amended by point b clause 42 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
163 This point is amended by point b clause 42 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
164 This point is added by point c clause 42 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
165 This clause is added by point d clause 42 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
166 Title of this clause is amended by point a clause 43
Article 5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018
on amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
167 This point is amended by point a clause 43 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
168 Title of this clause is amended by point b clause 43
Article 5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018
on amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
169 This point is amended by point c clause 43 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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171 Title of this clause is amended by point a clause 44
Article 5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018
on amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
172 This point is amended by point b clause 44 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
173 This clause is amended by clause 45 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
174 This point is amended by clause 46 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
175 This point is amended by clause 46 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
176 This point is amended by clause 46 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
177 This point is amended by clause 46 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
178 This point is repealed by clause 44 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
179 This point is repealed by clause 45 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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181 This point is repealed by clause 46 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
182 This point is repealed by clause 47 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
183 Title of this Article is amended by point a clause 47
Article 5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018
on amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
184 This point is
amended by clause 1 Article 2 of the Government’s Decree No. 88/2023/ND-CP
dated December 11, 2023 amendments to Decree No. 54/2017/ND-CP dated
May 08, 2017 on guidelines for implementation of the Law on Pharmacy and
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since December
11, 2023.
185 This point is amended by clause 1 Article 2 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
186 This clause is amended by clause 1 Article 1 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
187 This clause is amended by point a clause 48 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
188 This point is amended by point b clause 48 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
189 This point is amended by point c clause 48 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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191 This clause is amended by point dd clause 48 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
192 This clause is amended by point e clause 48 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state management
of the Ministry of Health, which has been effective since November 12, 2018.
193 This clause is amended by point e clause 48 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments
to regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
194 This clause is amended by point e clause 48 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
195 Title of this clause is amended by point a clause 2 Article
1 of the Government’s Decree No. 88/2023/ND-CP dated December 11, 2023
amendments to Decree No. 54/2017/ND-CP dated May 08, 2017 on
guidelines for implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
196 This clause is amended by clause 50 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
197 This point is amended by point a clause 49 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
198 This point is amended by clause 2 Article 2 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
199 This point is amended by clause 2 Article 2 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
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201 Title of this clause is amended by point a clause 2 Article
1 of the Government’s Decree No. 88/2023/ND-CP dated December 11, 2023
amendments to Decree No. 54/2017/ND-CP dated May 08, 2017 on
guidelines for implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
202 This point is amended by point c clause 49 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
203 This point is amended by point d clause 49 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
204 This point is amended by point d clause 49 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
205 Title of this clause is amended by point c clause 2 Article
1 of the Government’s Decree No. 88/2023/ND-CP dated December 11, 2023
amendments to Decree No. 54/2017/ND-CP dated May 08, 2017 on
guidelines for implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
206 This clause is amended by clause 49 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
207 This clause is amended by clause 51 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
208 This point is amended by point dd clause 49 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
209 This point is repealed by clause 52 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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211 This point is repealed by clause 52 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
212 This point is amended by clause 50 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
213 This point is amended by point a clause 3 Article 1 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
214 This clause is amended by point b clause 3 Article 1 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
215 This clause is amended by point c clause 3 Article 1 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
216 This point is amended by clause 4 Article 1 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
217 This point is amended by clause 5 Article 1 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
218 This point is repealed by clause 53 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
219 This point is repealed by clause 53 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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221 This point is repealed by clause 53 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
222 This point is repealed by clause 53 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
223 This point is amended by clause 51 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
224 This point is amended by clause 51 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
225 This point is amended by clause 52 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
226 This point is amended by point a clause 53 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
227 This point is repealed by clause 54 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
228 This point is amended by point b clause 53 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
229 This clause is amended by point c clause 53 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
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231 This point is repealed by clause 55 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
232 The phrase "tái xuất" ("re-exporting")
is repealed by clause 55 Article 4 of the Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 on amendments to regulations relating to
business conditions under state management of the Ministry of Health, which has
been effective since November 12, 2018.
233 The paragraph "Đối với nguyên liệu nhập khẩu được tái
xuất, Bộ Y tế thông báo cho cơ quan quản lý có thẩm quyền của nước tiếp nhận để
biết, phối hợp quản lý" ("In the cases where re-export of medicinal
ingredients is permitted, the Ministry of Health shall inform a competent
authority of the importing country.") is repealed by clause 55 Article 4
of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments
to regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
234 This Article is amended by clause 54 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
235 Title of this Article is amended by clause 55 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
236 This clause is repealed by clause 56 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
237 This clause is repealed by clause 56 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
238 This point is repealed by clause 57 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
239 This point is amended by clause 56 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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241 This point is amended by clause 56 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
242 This Article is repealed by clause 58 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
243 This Article is repealed by clause 59 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
244 This Article is amended by point a clause 57 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
245 This clause is amended by point b clause 57 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
246 This clause is repealed by clause 60 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
247 This clause is amended by point b clause 57 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
248 This clause is amended by point b clause 57 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
249 This clause is amended by clause 58 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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251 This point is amended by clause 59 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
252 This Article is repealed by clause 61 Article 4 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
253 This Article is repealed by clause 62 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
254 This Article is amended by clause 60 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
255 Title of this Article is amended by clause 61 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
256 This clause is repealed by clause 63 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
257 This clause is repealed by clause 63 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
258 This point is repealed by clause 64 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
259 This point is amended by clause 62 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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261 This point is amended by clause 62 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
262 This Article is repealed by clause 65 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
263 This Article is repealed by clause 66 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
264 Title of this Article is amended by point a clause 63
Article 5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018
on amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
265 This clause is amended by point b clause 63 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
266 This clause is repealed by clause 67 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
267 This clause is amended by point b clause 63 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
268 This clause is amended by point b clause 63 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments
to regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
269 This Article is amended by clause 64 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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271 This Article is amended by clause 66 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
272 This clause is amended by clause 67 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
273 This point is repealed by clause 68 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
274 This point is amended by clause 68 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
275 This point is amended by clause 69 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
276 Title of this clause is amended by clause 6 Article 1 of
the Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
277 This point is amended by clause 70 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since November 12, 2018.
278 This point is amended by clause 70 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
279 This point is amended by clause 70 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
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281 This point is repealed by clause 69 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
282 This point is repealed by clause 69 Article 4 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
283 This Article is amended by clause 7 Article 1 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
284 This Article is amended by clause 8 Article 1 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
285 This Article is amended by clause 9 Article 1 of the
Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to
Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for
implementation of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023.
286 This clause is amended by clause 76 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
287 The phrase “người phụ trách về bảo đảm chất lượng thuốc của
cơ sở sản xuất dược chất trừ trường hợp dược chất vô trùng” (“person in charge
of drug quality assurance of manufacturers of active ingredients other than
sterile active ingredients”) is repealed by Article 4 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
288 The phrase “người chịu trách nhiệm về đảm bảo chất lượng
thuốc” (“person in charge of drug quality assurance”) is repealed by Article 4
of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
289 This clause is amended by Article 5 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations
relating to business conditions under state management of the Ministry of
Health, which has been effective since November 12, 2018.
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291 Clause 4 Article 21 of the Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 on amendments to regulations relating to
business conditions under state management of the Ministry of Health, which has
been effective since November 12, 2018, stipulates that:
“Article
21. Transition clauses
......
4.
Transitional clauses for Decree No. 54/2017/ND-CP:
a) If the
applications for the practice certificates or the Certificates of Eligibility
for Pharmacy Business or the import and export licenses which are specified in
the Decree No. 54/2017/ND-CP are submitted before this Decree takes effect,
they shall be processed according to the regulations in the aforesaid Decree;
b) The
medicinal materials, which are used for producing drugs and are licensed before
this Decree takes effect, shall continue to be imported until the expiration
date of the license;
c) The drugs which are procured by the retailers in the
health facilities before this Decree takes effect shall comply with the
regulations in the Decree No. 54/2017/ND-CP .”
Article 4
of the Government’s Decree No. 88/2023/ND-CP on amendments to Decree
No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation
of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the Ministry
of Health, which has been effective since December 11, 2023, stipulates that:
“Article
4. Transition clauses
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292 This clause is amended by point a clause 78 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state management
of the Ministry of Health, which has been effective since November 12, 2018.
293 This point is amended by point b clause 78 Article 5 of the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since November 12, 2018.
294 This clause is amended by point c clause 78 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
295 This clause is amended by point d clause 78 Article 5 of
the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on
amendments to regulations relating to business conditions under state
management of the Ministry of Health, which has been effective since November
12, 2018.
296 Article 20 of the Government’s Decree No. 155/2018/ND-CP
dated November 12, 2018 on amendments to regulations relating to business
conditions under state management of the Ministry of Health, which has been effective
since November 12, 2018, stipulates that:
“Article
20. Entry into force
This
Decree comes into force from the date of signing.”
Article 3
of the Government’s Decree No. 88/2023/ND-CP on amendments to Decree
No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation
of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023,
stipulates that:
“Article
3. Entry into force
...
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297 Article 22 of the Government’s Decree No. 155/2018/ND-CP
dated November 12, 2018 on amendments to regulations relating to business
conditions under state management of the Ministry of Health, which has been
effective since November 12, 2018, stipulates that:
“Article
22. Responsibility for implementation
Ministers,
Heads of ministerial agencies, Heads of governmental agencies and Chairpersons
of People’s Committees of provinces and central-affiliated cities shall
implement this Decree./.”
Article 5
of the Government’s Decree No. 88/2023/ND-CP on amendments to Decree
No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation
of the Law on Pharmacy and Government’s Decree
No. 155/2018/ND-CP dated November 12, 2018 on amendments to
regulations relating to business conditions under state management of the
Ministry of Health, which has been effective since December 11, 2023,
stipulates that:
“Article
5. Responsibility for implementation
Ministers,
Heads of ministerial agencies, Heads of governmental agencies, Chairpersons of
People’s Committees of provinces and central-affiliated cities and relevant
organizations and individuals shall be responsible for the implementation of
this Decree./.”
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