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THE GOVERNMENT
OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No: 163/2025/ND-CP
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Hanoi, June 29,
2025
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DECREE
ELABORATING
CERTAIN ARTICLES AND MEASURES FOR THE IMPLEMENTATION OF THE LAW ON PHARMACY
Pursuant to the Law on Organization of the
Government dated February 18, 2025;
Pursuant to the Law on Organization of Local
Government dated February 16, 2025;
Pursuant to the Law on Pharmacy dated April 6,
2016; Law on amendments to certain Articles of the Law on Pharmacy dated
November 21, 2024;
At the request of the Minister of Health;
The Government of Vietnam elaborates certain
articles and measures for the implementation of the Law on Pharmacy.
Chapter I
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Article 1. Scope and regulated
entities
1. This Decree elaborates point d Clause 26 Article
2, point b Clause 2 Article 13, Clause 4 Article 29, Clause 3 Article 34,
Clause 5 Article 38, Clause 2 Article 41, Clause 6 Article 54, Clauses 4 and 5
Article 60, Clause 3 Article 69 of the Law on Pharmacy No. 105/2016/QH13;
Clause 4, Clause 5, Clause 9, point a and point c Clause 18, point d and dd
Clause 32, Clause 33, Clause 39, Clause 43 Article 1 of Law No. 44/2024/QH15
providing amendments to certain Articles of the Law on Pharmacy No.
105/2016/QH13 (hereinafter referred to as the Law on Pharmacy)
2. Measures for organizing the implementation
of the Law on Pharmacy include:
a) Management of import of drugs without a
marketing authorization for medicines in Vietnam;
b) Regulations on remaining shelf life of drugs,
medicinal materials at the time of customs clearance;
c) Regulations on checkpoint of import;
requirements for supply facilities of imported drugs and medicinal materials;
suspension of receiving applications for import licenses for drugs and
medicinal materials; suspension of issuance of import licenses for drugs and
medicinal materials; suspension of import of drugs and medicinal materials;
regulations on reports on export and import of drugs and medicinal materials;
regulations on suspension of receiving applications for issuance, renewal of
marketing authorization for drugs and medicinal materials; suspension of
receiving first-time applications and suspension of handling of submitted
applications for confirmation of contents of pharmaceutical advertisements;
d) Regulations on documents to be submitted upon
customs clearance of drugs and medicinal materials.
3. This Decree shall be applies to domestic and
foreign agencies, organizations, and individuals engaged in pharmaceutical
activities in Vietnam.
Chapter II
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Section 1. APPLICATIONS,
PROCEDURES FOR ISSUANCE, REISSUANCE, MODIFICATION, AND REVOCATION OF PHARMACY
PRACTICE CERTIFICATES
Article 2. Detailed regulations
on applications for issuance of pharmacy practice certificates
1. The application for issuance of pharmacy
practice certificates shall be prepared in accordance with Article 24 of the
Law on Pharmacy. To be specific:
a) Application form for pharmacy practice certificates
made using Form No. 02 in Appendix I attached hereto;
b) Equivalence certificates issued by competent
authorities for equivalence recognition in accordance with Clause 2
Article 12 of this Decree for foreign qualifications.
c) Certificate of internship made using Form 03 in
Appendix I attached hereto. 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;
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 scope or 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;
d) The criminal record is not required from the
date the criminal record data is shared in accordance with Clause 5 Article 127
of this Decree.
2. Documents issued by foreign competent
authorities must be consularly legalized and enclosed with notarized Vietnamese
translations.
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Article 3. Detailed regulations
on applications for reissuance of pharmacy practice certificates
1. The application for reissuance of pharmacy
practice certificates shall be prepared in accordance with Article 25 of the
Law on Pharmacy. To be specific:
a) Application form for reissuance of pharmacy
practice certificates made using Form No. 04 in Appendix I attached hereto;
b) The issued pharmacy practice certificate except
for the case where it is lost.
2. Only 01 set of documents specified in this
Article is required. Documents specified in point b, Clause 1 of this Article
must be certified true copies or copies accompanied by the original for
verification.
Article 4. Detailed regulations
on applications for adjustment of pharmacy practice certificates
1. Applications for adjustment of pharmacy
practice certificates shall be prepared in accordance with Article 26 of the
Law on Pharmacy. To be specific:
a) Application form for adjustment of pharmacy
practice certificates made using Form No. 05 in Appendix I attached hereto;
b) If the applicant’s scope of practice has to be
adjusted, relevant qualifications and a certificate of internship at an
appropriate pharmaceutical facility must be included. If the qualification is
issued overseas, its equivalence certification issued by a competent authority
specified in Clause 2 Article 12 hereof must be included.
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3. Only 01 set of documents specified in this
Article is required. Documents specified in point b, Clause 1 of this Article
and Clauses 2 and 3 of Article 26 of Law on Pharmacy must be certified true copies
or copies accompanied by the original for verification.
Article 5. Detailed regulations
on procedures for issuance of pharmacy practice certificates after passing an
examination
1. The applicant shall submit an application for
issuance of the pharmacy practice certificate whether in person or by post or
online to the Ministry of Health.
2. The Ministry of Health shall, after receiving
the application, issue an application receipt form made using form No. 01 in
Appendix I attached hereto.
3. Cases where the application is not required to
amend or supplement include:
a) The Ministry of Health shall assign a facility
that meets the requirements stipulated in Article 17 of this Decree and is
suitable for the applicant's place of residence to organize the examination for
granting the pharmacy practice certificate within 03 working days from the date
indicated on the application receipt form;
b) The facility stipulated in point a of this
Clause shall organize the examination for granting the pharmacy practice
certificate within 07 working days and send the exam results to the Ministry of
Health within 03 working days from the date of the examination;
c) If the exam results meet the requirements,
within 07 working days from the date of receiving the exam results sent by the
organizing facility, the Ministry of Health shall issue and provide the
applicant 01 copy of the pharmacy practice certificate.
d) If the exam results fail to meet the
requirements, within 07 working days from the date of receiving the exam
results sent by the organizing facility, the Ministry of Health shall notify
the applicant in writing according to Form No. 16 in Appendix I attached hereto
regarding the non-issuance of the pharmacy practice certificate.
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4. If the application is unsatisfactory, within 07
working days from the date indicated on the application receipt form, the
Ministry of Health shall request the applicant in writing to complete the
application using the Form No. 16 in Appendix I attached hereto.
5. The Ministry of Health shall, after receiving
the supplemented application, issue an application receipt form made using
form No. 01 in Appendix I attached hereto.
a) If the supplemented application is
unsatisfactory, within 07 working days from the date indicated on the
application receipt form, the Ministry of Health shall notify the applicant in
writing according to Form No. 16 in Appendix I attached hereto regarding the
non-issuance of the pharmacy practice certificate;
b) If there are no requests for amendments or
supplements to the supplemented application, the Ministry of Health and the
assigned examination facility shall comply with Clause 3 of this Article.
6. Within 06 months from the date on which the
Ministry of Health requests the applicant in writing to complete the
application, the applicant must submit a satisfactory application as requested.
If the applicant fails to submit a satisfactory application by the
aforementioned deadline, the submitted application will be invalid.
7. Within 03 working days from the date of issuance
of the pharmacy practice certificate, the Ministry of Health shall disclose and
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.
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9. In the cases where a pharmacy practice
certificate is issued according to Clause 8 Article 24 of Law on Pharmacy, the
applicant is exempt from fees.
Article 6. Detailed regulations
on procedures for issuance, reissuance, or adjustment of pharmacy practice
certificates without taking an examination
1. The applicant shall submit an application for
issuance, reissuance or adjustment of the pharmacy practice certificate whether
in person or by post or online to the Department of Health.
2. The Department of Health shall, after receiving
the application, issue an application receipt form made using form No. 01 in
Appendix I attached hereto.
3. In the cases where the application is not
required to amend or supplement, the Department of Health shall:
a) Issue and provide the applicant 01 copy of
the pharmacy practice certificate within 20 days from the date indicated on the
application receipt form;
b) Issue and provide the applicant 01 copy of
the pharmacy practice certificate within 05 days from the date indicated on the
application receipt form in the cases where the pharmacy practice certificate
is revoked in accordance with Clause 3 Article 28 of Law on Pharmacy.
c) Reissue, adjust and provide the applicant 01
copy of the pharmacy practice certificate within 10 days from the date
indicated on the application receipt form.
4. If the application is unsatisfactory, the
Department of Health shall request the applicant in writing to complete the
application using the Form No. 16 in Appendix I attached hereto:
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b) within 05 working days from the date indicated
on the receipt form of the application for reissuance or adjustment of the
pharmacy practice certificate.
5. The Department of Health shall, after receiving
the supplemented application, issue an application receipt form made using
form No. 01 in Appendix I attached hereto.
a) If the supplemented application is
unsatisfactory, within 07 working days from the date indicated on the receipt
form of the application for issuance of the pharmacy practice certificate or 05
working days from the date indicated on the receipt form of the application for
reissuance or adjustment of the pharmacy practice certificate, the Department
of Health shall notify the applicant in writing according to Form No. 16 in
Appendix I attached hereto regarding the non-issuance, non-reissuance, or
non-adjustment of the pharmacy practice certificate;
b) If there are no requests for amendments or
supplements to the supplemented application, the Department of Health shall
comply with Clause 3 of this Article.
6. Within 06 months from the date on which the
Department of Health requests the applicant in writing to complete the
application, the applicant must submit a satisfactory application as requested.
If the applicant fails to submit a satisfactory application by the
aforementioned deadline, the submitted application will be invalid.
7. Within 03 working days from the date of
issuance, reissuance, or adjustment of the pharmacy practice certificate, the
Department of Health shall disclose and 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.
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9. The pharmacy practice certificate issued to the
practitioner in cases of issuance, reissuance, or adjustment without taking an
examination shall be made using the Form No. 06 in Appendix I attached hereto.
10. The Minister of Health shall elaborate the
organization and operation of the Advisory Council for issuance of pharmacy
practice certificates.
11. In the cases where a pharmacy practice
certificate is issued according to Clause 8 Article 24 of Law on Pharmacy, the
applicant is exempt from fees.
Article 7. Procedures for
revocation of pharmacy practice certificates
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 issue a decision to revoke the
pharmaceutical practice certificate under its management; 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 to revoke the pharmacy practice certificate or
proposal to correct the erroneous pharmacy practice certificate is received,
the issuing authority shall issue a decision to revoke the pharmaceutical practice
certificate under its management; or respond the proposing authority and
provide explanation if such proposal is rejected.
3. Within 03 working days from the day on which the
decision to revoke the pharmaceutical practice certificate is issued, the issuing
authority shall:
a) Publish the decision to revoke the
pharmaceutical practice certificate on its website and send it to the Ministry
of Health and other Departments of Health nationwide;
b) Update information about revocation of the
pharmacy practice certificate on its website.
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Section 2. REFRESHER COURSES
IN PHARMACY
Section 8. Facilities offering
refresher training courses in pharmacy
1. Facilities offering refresher training courses
in pharmacy include: Higher education institutions, vocational education
institutions providing training in medicine or pharmacy; research institutes
with functions of training in medicine or pharmacy; facilities providing
training health workers; pharmacy associations.
2. Facilities offering refresher training courses
in pharmacy must develop their training programs with the following principal
contents:
a) The training contents include pharmacy
professional knowledge, law and management;
b) Duration of the refresher training course: at
least 08 hours.
Article 9. Responsibilities of
a refresher training facility
1. Make assessment and issue certificates of
completion of the refresher training course according to Form No. 08 in
Appendix I enclosed herewith.
2. Report to the Department of Health at the
headquarters and publish information about the status of refresher training
courses, list of individuals issued certificates of completion of refresher training
course including number, date of issuance of the pharmacy practice certificate,
content of refresher training course, and date of issuance of the
certificate of completion on its website.
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1. The Ministry of Health shall inspect and
supervise the refresher training facilities specified in Article 8 hereof.
2. The Department of Health shall:
a) Publish the performance of refresher training
facilities in the province on its website;
b) Update the list of people who have completed the
refresher course at refresher training facilities in the province on its
website;
c) Inspect, supervise and cooperate with refresher
training facilities in the province specified in Article 8 hereof in providing
refresher trainings in pharmacy.
Section 3. STANDARDIZATION OF
QUALIFICATIONS AND PROFESSIONAL TITLES FOR ISSUANCE OF PHARMACY PRACTICE
CERTIFICATES
Section 11. Qualifications
and professional titles eligible for issuance of pharmacy practice
certificates
1. Bachelor’s degree in pharmacy which is granted
by a domestic higher education institution and the title written in which is
“Pharmacist”, “Bachelor of Pharmacy”, or “High-rank pharmacist”.
2. Bachelor’s degree in general medicine which is
granted by a domestic higher education institution and the title written in
which is “Physician” or “General physician”.
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4. Bachelor’s degree in biology which is granted by
a domestic higher education institution.
5. Bachelor’s degree in chemistry which is granted
by a domestic higher education institution.
6. Level 5 of VQF diploma in pharmacy which is
granted by a domestic education institution.
7. Level 4 of VQF diploma in pharmacy which is
granted by a domestic education institution and the title written in which is
“Level 4 of VQF diploma of Pharmacy” or “Pharmacy technician”.
8. Level 5 of VQF diploma or Level 4 of VQF diploma
in medicine which is granted by a domestic education institution.
9. Level 4 of VQF diploma in traditional medicine
or traditional pharmacy which is granted by a domestic education institution.
10. Basic diploma in pharmacy which is granted by a
domestic education institution and the title written in which is "
pharmacist assistant” or “Level 5 of VQF diploma of Pharmacy”.
Article 12. Determination of
scope of practice of holders of undefined qualifications and titles
1. If a qualification issued by a domestic training
institution does not specify any of the titles specified in Clause 1, 2, 7, 10
Article 11 hereof, the scope of practice shall be decided by the issuer of the
pharmacy practice certificate on the basis of counsel provided by the Advisory
Council for issuance of pharmacy practice certificates.
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Section 4. INTERNSHIP IN
PHARMACY
Article 13.
Internship-offering establishments
1. Internship-offering establishments are
establishments specified in Clause 2 Article 13 of Law on Pharmacy, including:
Pharmacy business establishments, pharmacies of healthcare and medical
facilities, pharmacy training institutions, pharmacy research institutions (including
research institutions for drug and medicinal material development,
research institutions for vaccine and biological product, drug information and
pharmacovigilance, research institutions for pharmacology and clinical
pharmacy), laboratories testing drugs and medicinal materials, pharmacy
authorities, representative offices of foreign traders engaged in pharmacy in
Vietnam (hereinafter referred to as “pharmaceutical facilities”); healthcare
and medical facilities suitable for qualifications of interns.
2. An internship-offering establishment is
considered suitable is an establishment mentioned in Clause 1 of this Article
with suitable operation for qualifications of interns according to
Article 14 hereof.
3. The internship-offering establishments shall confirm
internship durations for interns therein according to Form No. 03 in
Appendix I enclosed herewith and take responsibility for such confirmation.
Article 14. Internship
contents
1. Pharmacists of manufacturers of drugs, active pharmaceutical
ingredients (drug substances), 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 contents: drug manufacture, drug testing, research and development of
drugs, pharmacy management at a pharmacy authority; specialized course teaching
or professional orientation at a pharmacy training institution;
b) The chief pharmacist of a manufacturer of
medicinal materials that are drug substances, excipients and capsule shells
shall complete one of the following contents: drug manufacture, drug testing,
research and development of drugs and medicinal materials, pharmacy management
at a pharmacy authority; specialized course teaching or professional
orientation at a pharmacy training institution;
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d) The chief pharmacist of a traditional drug
manufacturer shall complete one of the following 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; specialized course
teaching or professional orientation at a pharmacy training institution.
2. Persons in charge of quality assurance of
manufacturers of drugs, drug substances, 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 contents: manufacture, testing, quality
assurance, research and development at a drug-manufacturing facility or
drug-testing of facility;
b) The person in charge of quality assurance of a
manufacturer of medicinal materials that are drug substances, excipients and
capsule shells shall complete one of the following contents: manufacture,
testing, quality assurance, research and development at a facility
manufacturing drugs or medicinal materials or a drug-testing of facility;
c) The person in charge of quality assurance of a
manufacturer of vaccines and biologicals and ingredients thereof shall complete
one of the following 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 contents: manufacture and processing of herbal materials,
traditional drugs and herbal drugs, testing of drugs, 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; specialized course teaching or professional orientation at
a pharmacy training institution;
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 contents: manufacture and
processing of drugs and herbal drugs, testing of drugs, 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; specialized course teaching or professional
orientation at a pharmacy training institution;
4. Pharmacists of wholesalers of drugs and
medicinal materials:
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b) The pharmacist of a wholesaler of medicinal
materials shall complete one of the following 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; specialized course teaching or professional orientation at a
pharmacy training institution; registration of drugs at a representative office
of a foreign drug trader;
c) The pharmacist of a wholesaler of medicinal
materials shall complete one of the following contents: manufacture, wholesaling,
storage, testing of vaccines and biologicals; medicine or pharmacy management
at a pharmacy authority; research into vaccines and biologicals; pharmacy
management at a pharmacy authority; specialized course teaching or professional
orientation at a pharmacy training institution; registration of drugs at a
representative office of a foreign drug trader;
d) The chief pharmacist of a wholesaler of herbal
materials, herbal drugs and traditional drugs shall complete one of the
following 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;
specialized course teaching or professional orientation at a pharmacy training
institution.
5. Pharmacists of exporters and importers of drugs
and medicinal materials:
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 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;
specialized course teaching or professional orientation at a pharmacy training
institution; registration of drugs at a representative office of a foreign drug
trader;
b) The chief pharmacist of an exporter or importer
of vaccines and biologicals shall complete one of the following contents:
export and import of vaccines and biological; manufacture of vaccines and
biological; wholesaling of vaccines and biological; provision of vaccine and
biological storage services; testing of vaccines and biologicals; research into
vaccines and biologicals; use of vaccines and biologicals; pharmacy management
at a pharmacy authority; specialized course teaching or professional
orientation at a pharmacy training institution; registration of drugs at a
representative office of a foreign drug trader;
c) The chief pharmacist of an exporter or importer
of herbal materials, herbal drugs and traditional drugs shall complete one of
the following 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; specialized course teaching or
professional orientation at a pharmacy training institution; registration of
drugs at a representative office of a foreign drug trader.
6. Pharmacists of drug retailers:
a) The chief pharmacist of a drugstore or
dispensary of a commune shall complete one of the following contents:
wholesaling and retailing of drugs; export and import of drugs; clinical
pharmacology; supply of drugs for healthcare and medical facilities;
manufacture of drugs; testing of drugs and medicinal materials; pharmaceutical
research; drug storage; drug distribution; pharmacy management at a
pharmacy authority; specialized course teaching or professional orientation at
a pharmacy training institution;
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7. Pharmacists of drug/medicinal materials testing
service providers:
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 contents: testing of drugs and
medicinal materials; research related to manufacture, testing, analysis of
drugs and medicinal materials; pharmacy management at a pharmacy authority;
specialized course teaching or professional orientation at a pharmacy training
institution;
b) The chief pharmacist of a provider of vaccine
and biological testing services shall complete one of the following 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; specialized course teaching or professional orientation at a
pharmacy training institution;
8. The pharmacist of a provider of clinical trial
or bioequivalence study services shall complete one of the following contents:
bioequivalence study; clinical trial; testing of drugs and medicinal materials;
pharmacology and clinical pharmacology research; traditional pharmacy or
traditional medicine management at a pharmacy authority; specialized course
teaching or professional orientation at a pharmacy training institution.
9. Persons in charge of clinical pharmacology of
medical facilities:
a) The person in charge of clinical pharmacology of
a medical facility, except for the cases in point b hereof, shall complete one
of the following contents: bioequivalence study; clinical trial; pharmacology
and clinical pharmacology teaching at a pharmacy training institution;
pharmacology and clinical pharmacology research; pharmacovigilance at the drug
information and advert reaction monitoring center; clinical pharmacology at a
medical facility;
b) The person in charge of clinical pharmacology of
a traditional medicine facility shall complete one of the following contents: clinical
trial; pharmacology and clinical
pharmacology research; pharmacovigilance at the drug information and advert
reaction monitoring center, clinical pharmacology practice at a traditional
medicine facility.
10. Pharmacists of providers of drug/medicinal
materials storage services:
b) The chief pharmacist of a provider of vaccine
and biological storage services shall complete one of the following contents:
storage of vaccines and biological; manufacture of vaccines and biologicals;
testing of vaccines and biologicals; pharmacy management at a pharmacy
authority; specialized course teaching of professional orientation at a
pharmacy training institution.
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Article 15. 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 (hereinafter referred to as
“master’s degree”)
b) a doctorate degree in pharmacy, medicine,
traditional medicine, chemistry or biology (hereinafter referred to as “PhD”);
c) Specialized Level 1 (SL1) or Specialized Level 2
(SL2) degree according to regulations of the Minister of Health..
2. The specific internship durations at the
pharmaceutical facility which comply with 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;
b) ½ of the duration for holders of Master's
Degrees or SL1 degrees;
Section 5. EXAMINATIONS FOR
THE PHARMACY PRACTICE CERTIFICATE
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1. The examination may be held at an examination
center or online.
2. Examination contents:
a) General pharmaceutical knowledge;
b) Special knowledge compulsory for the positions
in accordance with Article 11 of the Law on Pharmacy.
3. The Minister of Health shall specify
regulations, examination contents, question banks and grading scale.
Article 17. Eligibility of
examination centers
Examination centers must be institutions that
provide higher education training in pharmacy or traditional pharmacy.
Article 18. Examination fee
Candidates shall pay the examination fees for
pharmacy practice certificate as prescribed by law.
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PHARMACY BUSINESS
Section 1. CERTIFICATE OF
ELIGIBILITY FOR PHARMACY BUSINESS
Article 19. Eligibility for
traditional drug business
1. A manufacturer of traditional drugs that are
sold nationwide shall meet the requirements in points a, c, and d of Clause 2
Article 69 of Law on Pharmacy.
2. Exporter or importer of traditional drugs shall
have facilities, technical documents, and personnel meeting GSP
requirements. The chief pharmacist of an exporter or importer of traditional
drugs shall satisfy the requirements in Clause 3 Article 17 of Law on
Pharmacy.
3. Providers of traditional drug storage services
shall have facilities, technical documents, and personnel meeting GSP
requirements. The chief pharmacist of a provider of traditional drug storage
services shall satisfy the requirements in Clause 1 Article 22 of Law on
Pharmacy.
4. Wholesaler of traditional drugs shall have
facilities, technical documents, and personnel meeting GSP requirements.
The chief pharmacist of a wholesaler of traditional drugs shall satisfy the
requirements in Clause 3 Article 16 of Law on Pharmacy.
5. Requirements to be satisfied by retailers of
herbal materials, herbal drugs and traditional drugs:
a) The chief pharmacist of a retailer of herbal
materials, herbal drugs and traditional drugs shall satisfy the requirements in
Clause 4 Article 18 of Law on Pharmacy.
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c) 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 “toxic herbal materials” to avoid
confusion.
Retailers of herbal drugs and traditional drugs or
retailers of herbal materials shall have suitable storage areas to store herbal
drugs or traditional drugs, or to store herbal materials or traditional
medicinal materials;
d) Instruments and primary packages of herbal
drugs, traditional drugs, or herbal materials 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 of the retailer and must not affect the herbal
materials, herbal drugs or traditional drugs.
Article 20. Detailed
regulations on applications for issuance, reissuance and adjustment of the
Certificate of eligibility for pharmacy business
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1. Form No. 10, 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 point b Clause
1 Article 38 of Law on Pharmacy, including:
a) If the applicant is a manufacturer of drugs or medicinal
materials: documents about facilities, 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 with the scope of manufacture and
distribution of drugs and medicinal materials to wholesalers, retailers, and
healthcare and medical facilities, documents about technologies and personnel
according to Good Distribution Practice (GDP) requirements for drugs and
medicinal materials must be submitted, except for cases of delivery at the
warehouse 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 facilities, documents about technologies and
personnel according to GMP requirements for drugs and medicinal materials;
c) If the applicant is a wholesaler of drugs
or medicinal materials: documents about facilities, documents about technologies
and personnel according to GDP requirements for drugs and medicinal
materials;
d) If the applicant is a drug retailer: documents
about facilities, documents about technologies and personnel according to
Good Pharmacy Practice (GPP) requirements;
If the applicant is a retailer of herbal materials,
herbal drugs and traditional drugs: documents proving fulfillment of the
requirements in Clause 5 Article 19 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 facilities, documents
about technologies 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 facilities, documents about technologies 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,
technical documents may not include documents about facilities, documents about
technologies and personnel according to GCP requirements;
h) If the applicant is a pharmacy chain: documents about
facilities, documents about technologies and personnel according to GDP
requirements for drugs and medicinal materials;
3. Technical documents specified in point b Clause
2 Article 38 of Law on Pharmacy include documents about facilities, documents about
technologies and personnel according to Clause 2 hereof corresponding to
the changing business conditions.
4. Only 01 set of documents specified in this
Article is required. Documents in applications for issuance, reissuance and
adjustment of the Certificate of eligibility for pharmacy business mentioned in
point c and point d Clause 1, point b and point c Clause 2, point b and point c
Clause 4 Article 38 of Law on Pharmacy are original copies, certified true
copies, or copies accompanied by the original for verification.
Article 21. Procedures for
issuance of the certificate of eligibility for pharmacy business
1. The applicant shall submit an application, in
person or by post or online, to:
a) the Ministry of Health in any of the cases
mentioned in points a, b, c, e, g, and h Clause 2 Article 32 of the Law on
Pharmacy;
b) Departments of Health in any of the cases
mentioned in points d and dd Clause 2 Article 32 of the Law on Pharmacy;
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3. The receiving authority shall:
a) issue the Certificate of eligibility for
pharmacy business within 30 days from the date indicated on the application
receipt form without a site inspection at the applicant’s premises, if the
applicant’s facilities and personnel are conformable with relevant Good
Practice requirements;
b) carry out a site inspection at the applicant’s
premises within 20 days from the date indicated on the application receipt
form.
4. If the application is
unsatisfactory according to point a Clause 3 hereof, within 07
working days from the date indicated on the application receipt form, the
receiving authority shall request the applicant in writing to complete the
application and specify necessary additional documents according to Form No. 16
in Appendix I enclosed herewith.
5. The Ministry of Health shall, after receiving
the application, issue an application receipt form made using form No. 01 in
Appendix I attached hereto.
a) If the supplemented application is
unsatisfactory, within 10 working days from the date indicated on the
application receipt form, the receiving authority shall notify the applicant in
writing according to Form No. 16 in Appendix I attached hereto regarding the
non-issuance of the certificate of eligibility for pharmacy business;
b) If there are no requests for amendments or
supplements to the supplemented application, the receiving authority shall
comply with point a Clause 3 of this Article.
6. After the site inspection is done according to point b Clause 3 of this Article, the
issuing 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;
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7. Within 20 days from the day on which the
notification and documents proving that all necessary remedial actions are taken
are received, the receiving authority shall issue the Certificate of
eligibility for pharmacy business or notification of amendments or supplements.
8. Within 06 months from the date of receipt of the
notification of amendments or supplements or notification of necessary remedial
actions, the applicant shall submit supplemented documents as requested or
notification and documents proving that all necessary remedial actions are
taken. If the applicant fails to submit a satisfactory application by the aforementioned
deadline, the submitted application will be invalid.
9. Within 03 working days from the date of issuance
of the Certificate of eligibility for pharmacy business, the receiving
authority shall disclose and update the following information on its website:
a) 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;
d) Scope of pharmacy business.
10. In the case specified in point b Clause 1
Article 36 of Law on Pharmacy, the applicant shall return the old
certificate, unless it is lost or it was issued online.
11. 01 copy made using Form No. 13 in Appendix I
enclosed herewith shall be given to the applicant.
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Article 22. Procedures for
reissuance and adjustment of the certificate of eligibility for pharmacy
business
1. The applicant shall submit an application for
reissuance or adjustment of the Certificate of eligibility for pharmacy
business, in person or by post or online, to:
a) the Ministry of Health in any of the cases
mentioned in points a, b, c, e, g, h and i Clause 2 Article 32 of the Law
on Pharmacy;
b) Departments of Health of the province of where
the applicant is located in any of the cases mentioned in points d and dd
Clause 2 Article 32 of the Law on Pharmacy;
2. The receiving authority shall, after receiving
the application, issue an application receipt form made using form No. 01 in
Appendix I attached hereto.
3. If the application is satisfactory, the
receiving authority shall:
a) reissue or adjust the Certificate of eligibility
for pharmacy business within 20 days from the date indicated on the application
receipt form, in the case mentioned in point a Clause 2 and Clause 3 of Article
36 of Law on Pharmacy;
b) reissue the Certificate of eligibility for
pharmacy business within 07 working days from the date indicated on the
application receipt form, in the case mentioned in point b Clause 2 Article 36
of Law on Pharmacy;
4. If the supplemented application is unsatisfactory,
within 05 working days from the date indicated on the application receipt form,
the receiving authority shall request the applicant in writing to complete the
application according to Form No. 16 in Appendix I attached hereto;
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a) If the supplemented application is
unsatisfactory, within 05 working days from the date indicated on the application
receipt form, the receiving authority shall notify the applicant in writing
according to Form No. 16 in Appendix I attached hereto regarding the
non-issuance of the certificate of eligibility for pharmacy business;
b) If the supplemented application is satisfactory,
the receiving authority shall reissue or adjust the Certificate of eligibility
for pharmacy business in accordance with Clause 3 of this Article.
6. Within 06 months from the date on which the
receiving authority requests the applicant in writing to complete the
application, the applicant must submit a satisfactory application as requested.
If the applicant fails to submit a satisfactory application by the
aforementioned deadline, the submitted application will be invalid.
7. Within 03 working days from the date of
reissuance or adjustment of the Certificate of eligibility for pharmacy
business, the receiving authority shall disclose and update the following
information on its website:
a) 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;
d) Scope of 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 or it was issued online.
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Article 23. 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 issue a decision to revoke the
certificate of eligibility for pharmacy business under its management; or
respond the proposing authority and provide explanation if such proposal is
rejected.
2. Within 03 working days from the day on which the
decision to revoke the certificate of eligibility for pharmacy business is
issued, the issuing authority shall:
a) Publish the decision to revoke the certificate
of eligibility for pharmacy business on its website and send it to the Ministry
of Health and other 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 shall publish such decision on its website.
Section 2. LOCATIONS, SCOPE OF
OPERATION OF RETAILING DISPENSARIES AND DRUG COUNTERS
Article 24. Locations of
retailing dispensaries and drug counters
1. Locations of retailing dispensaries:
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b) If the ratio of dispensary to 2,000 people in
ward that has just been converted from a commune or special zone 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 point a hereof and has already granted a
certificate of eligibility for drug business before the conversion into a
ward, it may operate for up to 03 more years from the conversion date.
2. Locations of drug counters:
In medical stations of communes and special zones;
Article 25. Scope of operation
of retailing dispensaries and drug counters
1. The scope of operation of a retailing dispensary
is specified in point b Clause 1 Article 48 of Law on Pharmacy.
2. The scope of operation of a drug counter is
specified in point b Clause 1 Article 48 of Law on Pharmacy.
Section 3. MOBILE DRUGSTORES
Article 26. The
eligibility to operate a mobile drugstore
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a) Drug manufacturers;
b) Drug wholesalers;
c) Drug retailers;
d) Health facilities of the people’s armed forces
and military-civil healthcare and medical facilities participating in supply of
drugs in ethnic minority areas, in mountainous areas, on islands, in
disadvantaged areas and extremely disadvantaged areas.
dd) Pharmacy chains.
2. The keeper of the mobile drugstore must be an
employee of a mobile drugstore 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.
Article 27. List of drugs and
area for mobile drugstore operation
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a) It is on the list of over-the-counter drugs;
b) It only requires normal storage conditions;
c) It is meant to serve common purposes of local
people, with a priority given to medicinal materials cultivated or harvested in
ethnic minority areas.
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 28. Procedures for
registration of a mobile drugstore
1. The applicant for registration of a mobile
drugstore shall submit Form No. 14 in Appendix I enclosed herewith to the
Department of Health of the province where the mobile drugstore operates.
2. Within 03 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 be
responsible 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 29. The list of
radioactive substances used in medicine; banned drugs and drug substances in
the list of banned substances in the certain fields
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2. The list of drugs and drug substances on the
list of substances banned from certain fields shall be disclosed as follows:
a) The Ministry of Agriculture and Environment, the
Ministry of Industry and Trade, the Ministry of Construction, other ministries
and ministerial authorities shall promulgate the list of banned substances in
the fields under their management and send the list to the Ministry of Health;
b) After receiving the list of banned substances
from the ministries and ministerial agencies stipulated in point a hereof, the
Ministry of Health shall promulgate the list of banned drugs and drug
substances in certain fields on its website.
Article 30. Security measures
to prevent the loss of controlled drugs and medicinal materials
1. To be allowed to trade in controlled drugs, the
trader shall comply with Articles 31, 32, 33, 34, 35, and 36 hereof.
2. To be allowed to trade in radiopharmaceuticals,
in addition to meeting the provisions of Clause 1 hereof, the trader must also
comply with Law on Atomic Energy and other relevant legislative documents.
3. The Ministry of Health and Departments of Health
shall conduct inspections once every 03 years or ad hoc inspections to ensure
compliance with regulations on security measures in this Section by traders of
controlled drugs in accordance with regulations of the Minister of Health or
international treaties to which Socialist Republic of Vietnam is a signatory.
Article 31. Facilities of
traders of controlled drugs
1. A manufacturer of narcotic drugs, psychotropic
drugs, precursor drugs, medicinal materials that are narcotic drug substances
and psychotropic drug substances, and drug precursors shall:
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b) have a camera system to monitor each stage
of the manufacture and storage process;
c) have a documentary management system according
to regulations of the Minister of Health.
2. A manufacturer of combination drugs that contain
narcotic drug substances, combination drugs that contain psychotropic drug
substances and combination drugs that contain precursors shall:
a) have a separate storage facility or area that
meets GSP requirements to store narcotic drugs, psychotropic drugs,
precursor drugs, medicinal materials that are narcotic drug substances,
psychotropic drug substances and drug precursors. Such separate storage
facility or area must have robust doors with locks;
b) have a separate storage facility or area that
meets GSP requirements to store combination drugs that contain narcotic drug
substances, combination drugs that contain psychotropic drug substances and
combination drugs that contain precursors. Such separate storage facility or
area must have robust doors with locks;
c) have a camera system to monitor each stage
of the manufacture and storage process;
d) have a documentary management system according
to regulations of the Minister of Health.
3. A manufacturer of radiopharmaceuticals shall:
a) have a separate storage facility or area that
meets GSP requirements to store radiopharmaceuticals and medicinal materials.
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c) have a camera system to in the manufacture and
storage area.
4. An exporter, importer of narcotic drugs,
psychotropic drugs, precursor drugs, medicinal materials that are narcotic drug
substances, psychotropic drug substances and drug precursors shall:
a) have a separate storage facility or area that
meets GSP requirements to store narcotic drugs, psychotropic drugs,
precursor drugs, medicinal materials that are narcotic drug substances,
psychotropic drug substances and drug precursors. Such separate storage
facility or area must have robust doors with locks;
b) Have a camera system in the storage area of
drugs and medicinal materials;
c) have a documentary management system according
to regulations of the Minister of Health.
5. An exporter, importer, wholesaler or provider of
storage services for combination drugs that contain narcotic drug substances,
combination drugs that contain psychotropic drug substances and combination drugs
that contain precursors shall: have a separate storage facility or area
with robust doors and locks that meets GSP requirements to store
combination drugs that contain narcotic drug substances, combination drugs that
contain psychotropic drug substances and combination drugs that contain
precursors; have a documentary management system according to regulations of
the Minister of Health.
6. An exporter, importer or wholesaler of
radiopharmaceuticals shall: have a documentary management system according to
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 to store narcotic drugs, psychotropic drugs, and precursor
drugs. Such separate storage facility or area must have robust doors with
locks;
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c) have a documentary management system according
to regulations of the Minister of Health.
8. A retailer of narcotic drugs, psychotropic
drugs or precursor drugs shall:
a) have a separate and locked cabinet or drawer to
store narcotic drugs, psychotropic drugs or precursor drugs;
b) have a documentary management system according
to regulations of the Minister of Health.
9. A retailer of combination drugs that
contain narcotic drug substances, combination drugs that contain psychotropic
drug substances, 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) have a documentary management system according
to regulations of the Minister of Health.
11. A provider of clinical study services,
bioequivalence study services, testing services or storage services for
radiopharmaceuticals shall:
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b) have a documentary management system according
to regulations of the Minister of Health.
c) have a camera system for providers of
radiopharmaceutical storage services.
12. 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 drug
substances, psychotropic drug substances or drug precursors, combination drugs
that contain narcotic drug substances, combination drugs that contain
psychotropic drug substances 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 drug substances in 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 32. Personnel of
traders of controlled drugs
1. Personnel of a manufacturer of narcotic
drugs, psychotropic drugs, precursor drugs, medicinal materials that are
narcotic drug substances, psychotropic drug substances or drug precursors:
a) The warehouse-keeper responsible for narcotic
drugs, medicinal materials that are narcotic drug substances shall have at
least a bachelor’s degree in pharmacy and had an internship at a pharmacy
business establishment that lasted at least 12 months;
b) The warehouse-keeper responsible for
psychotropic drugs, precursor drugs, medicinal materials that are
psychotropic drug substances or drug precursors shall have at least a level 4
of VQF diploma in pharmacy and had an internship at a pharmacy business
establishment that lasted at least 12 months.
2. Personnel of a manufacturer of combination drugs
that contain narcotic drug substances, combination drugs that contain
psychotropic drug substances and combination drugs that contain precursors
shall:
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b) The warehouse-keeper responsible for
psychotropic drugs, precursor drugs, medicinal materials that are
psychotropic drug substances or drug precursors shall have at least a Level 4
VQF diploma in pharmacy and had an internship at a pharmacy business
establishment that lasted at least 12 months.
3. Personnel of a manufacturer of
radiopharmaceuticals:
a) The warehouse-keeper shall have at least a Level
4 VQF diploma in pharmacy or bachelor’s degree in radiochemistry, radiology or
nuclear medicine;
b) 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 drug substances, psychotropic drug substances
or drug precursors: The warehouse-keeper responsible for narcotic drugs,
psychotropic drugs, precursor drugs, medicinal materials that are
narcotic drug substances, psychotropic drug substances 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 months.
5. 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 months;
b) The warehouse-keeper responsible for
psychotropic drugs or precursor drugs shall have at least a level 4 of VQF diploma
in pharmacy and had an internship at a pharmacy business establishment that
lasted at least 12 months.
6. Personnel of a retailer of narcotic
drugs, psychotropic drugs or precursor drugs:
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b) The warehouse-keeper responsible for
psychotropic drugs or precursor drugs shall have at least a Level 4 of VQF
diploma.
7. Personnel of a retailer of
radiopharmaceuticals: the person responsible for retailing such drugs must have
at least a Level 4 of VQF diploma.
8. Personnel of a provider of storage services
for narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials
that are narcotic drug substances, psychotropic drug substances and drug
precursors: The warehouse-keeper responsible for narcotic drugs,
psychotropic drugs, precursor drugs, medicinal materials that are
narcotic drug substances, psychotropic drug substances 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 months.
9. Personnel of a provider of clinical trial
services, bioequivalence study services, testing services that involve
radiopharmaceuticals for narcotic drugs, psychotropic drugs, precursor drugs,
medicinal materials that are narcotic drug substances, psychotropic drug
substances and drug precursors: The warehouse-keeper responsible for
narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that
are narcotic drug substances, psychotropic drug substances or drug
precursors shall have at least a Level 4 of VQF diploma.
10. Personnel of a provider of clinical study
services, bioequivalence study services, testing services or storage services
for radiopharmaceuticals:
a) The warehouse-keeper shall have at least a
Level 4 of VQF diploma 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) The supervisor of research, manufacture,
analysis, testing processes shall have at least a bachelor’s degree in
radiochemistry, radiology, nuclear medicine or pharmacy.
Article 33. Delivery and
receipt of controlled drugs and medicinal materials
1. The deliverer and recipient of controlled drugs
or medicinal materials shall have at least a Level 4 of VQF diploma in
pharmacy; the deliverer and recipient of radiopharmaceuticals shall also have a
certificate of training in radiation safety in accordance with atomic energy
laws.
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3. Upon delivery of narcotic drugs, psychotropic
drugs, precursor drugs, medicinal materials that are narcotic drug
substances, psychotropic drug substances 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 drug substances, psychotropic drug substances or drug precursors,
narcotic drugs, psychotropic drugs, precursor drugs must ensure security and
prevent leakage. The transport of radiopharmaceuticals shall ensure radiation
safety and safe transport of radioactive materials in accordance with atomic
energy laws.
5. Each establishment participating in the delivery
of the radiopharmaceuticals shall have a license to perform radiological works
in accordance with atomic energy laws.
Article 34. Trading in
controlled drugs
1. Regarding medicinal materials that are narcotic
drug substances, psychotropic drug substances or drug precursors:
a) A manufacture may only import materials serving
the manufacture of its drugs;
b) An importer may only sell imported medicinal
materials to: drug manufacturers for their own manufacture activities;
healthcare and medical facilities for drug preparation to meet the treatment
needs; state-owned drug testing facilities for drug and medicinal material
testing, research and establishment of norms to serve drug and medicinal
material testing and research; scientific and technological organizations to
serve the research activities; training facilities engaged in research and
teaching related to pharmacy to serve research and teaching activities;
c) A manufacture may transfer its redundant materials to another
establishment after obtaining a written permission from the Ministry of Health
in accordance with Article 39 herewith.
2. Regarding narcotic drugs, psychotropic drugs,
precursor drugs and combination drugs that contain precursors of drug
manufacturers:
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b) Each manufacturer is only allowed to select 01
wholesaler in each province to sell all products manufactured by the facility.
3. Regarding narcotic drugs, psychotropic drugs,
precursor drugs and combination drugs that contain precursors of drug
importers:
a) An importer may only sell drugs it imports to
pharmacies; clinical trial service providers to conduct clinical trial
activities at the facility; bioequivalence testing service providers to serve
bioequivalence testing activities at the facility; testing service providers
for drug and medicinal materials and state-owned testing facilities for drug
and medicinal materials to serve drug and medicinal material testing activities
at the facility; healthcare and medical facilities, vaccination centers, and
drug rehabilitation facilities to serve healthcare and medical activities at
the facility; scientific and technological organizations to serve research
activities; training facilities engaged in research and teaching related to
pharmacy to serve research and teaching activities at the facility;
b) Each importer is only allowed to select 01
wholesaler in each province to sell all products imported by the facility.
c) A foreign-invested importer is only allowed to
sell drugs in accordance with point b of this Clause.
4. Regarding narcotic drugs, psychotropic drugs,
precursor drugs and combination drugs that contain precursors of establishments
that have the Certificate of eligibility for pharmacy business that allows
export, import and wholesaling of drugs:
a) The facility may sell drugs to pharmacies and
other establishments that have the Certificate of eligibility for pharmacy business
that allows export, import and wholesaling of drugs; pharmacies; clinical trial
service providers to serve clinical trial activities at the facility;
bioequivalence testing service providers to serve bioequivalence testing
activities at the facility; testing service providers for drug and medicinal
materials and state-owned testing facilities for drug and medicinal materials
to serve drug and medicinal material testing activities at the facility;
healthcare and medical facilities, vaccination centers, and drug rehabilitation
facilities to serve healthcare and medical activities at the facility;
scientific and technological organizations to serve research activities;
training facilities engaged in research and teaching related to pharmacy to
serve research and teaching activities at the facility;
b) Each facility is only allowed to select 01
wholesaler in each province to sell all products sold by the facility.
5. A wholesaler may only sell narcotic drugs,
psychotropic drugs, precursor drugs and combination drugs that contain
precursors to:
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b) Clinical trial service providers to serve
clinical trial activities at the facility;
c) Bioequivalence testing service providers to
serve bioequivalence testing activities at the facility;
d) Testing service providers for drug and medicinal
materials and state-owned testing facilities for drug and medicinal materials
to serve drug and medicinal material testing activities at the facility
dd) Healthcare and medical facilities, vaccination
centers, and drug rehabilitation facilities to serve healthcare and medical
activities at the facility;
e) Scientific and technological organizations to
serve research activities; training facilities engaged in research and teaching
related to pharmacy to serve research and teaching activities at the facility.
6. Regarding purchase and sale of drugs and
medicinal materials between facilities specified in Clauses 1, 2, 3, 4, and 5
hereof shall be carried out according to the Order approved by competent
authorities, except for the following cases: <0}
a) Purchasing drugs based on the bidding results
approved by the People's Committee of the province where the healthcare and
medical facilities, vaccination center, other healthcare facility, or drug
rehabilitation facility is located;
b) Purchasing drugs based on the bidding results
approved by the Ministry of National Defense for units affiliated to the
Ministry of National Defense;
c) Purchasing drugs based on the bidding results
approved by the Ministry of Public Security for units affiliated to the
Ministry of Public Security;
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8. In cases where there are no retailers selling controlled drugs, the
People's Committee of the province shall designate healthcare facilities to
transfer controlled drugs to ensure an adequate drug supply for patients.
Article 35. Reports on
controlled drugs
1. A manufacturer, exporter, or importer shall:
a) within 10 working days from the date of export
or import, prepare a report on the export or import of narcotic drugs,
psychotropic drugs, precursor drugs, medicinal materials that are
narcotic drug substances, psychotropic drug substances or drug
precursors according to Form No. 02 and Form No. 03 in Appendix II enclosed
herewith and send it to the Ministry of Public Security and receiving
authorities in accordance with Article 124 hereof;
b) by the 15th of July and 15th of
January, prepare a biannual report and an annual report on the export or import
of combination drugs that contain narcotic drug substances, combination drugs
that contain psychotropic drug substances, combination drugs that contain
precursors, radiopharmaceuticals, toxic drugs, drugs and drug substances
on the list of substances banned in certain fields according to Form No.
03 in Appendix II enclosed herewith and send it to receiving authorities in
accordance with Article 124 hereof;
c) by the 15th of July and 15th of
January, prepare a biannual report and an annual report on the export, import
inventory, and use of narcotic drugs, psychotropic drugs, precursor drugs,
combination drugs that contain narcotic drug substances, combination drugs that
contain psychotropic drug substances, combination drugs that contain
precursors, medicinal materials that are narcotic drug substances,
psychotropic drug substances or drug precursors according to Form No. 04
and Form No. 05 in Appendix II enclosed herewith and send it to receiving
authorities in accordance with Article 124 hereof;
d) by the 15th of January, prepare
an annual report on the export, import inventory, and use of
radiopharmaceuticals, medicinal materials that are radioactive substances,
toxic drugs, drugs and drug substances on the list of substances banned in
certain fields according to Form No. 04 in Appendix II enclosed herewith and
send it to receiving authorities in accordance with Article 124 hereof.
2. A wholesaler, retailer, or pharmacy chain shall:
a) By the 15th of July and 15th of
January, prepare a biannual report and an annual report on export, import,
inventory, and use of narcotic drugs, psychotropic drugs, precursor drugs,
combination drugs that contain narcotic drug substances, combination drugs that
contain psychotropic drug substances, combination drugs that contain
precursors according to Form No. 06 in Appendix II enclosed herewith and send
it to the People’s Committee of the province where the head office is
located.
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3. People’s Committees of provinces shall:
a) By the 30th of January, 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. 08 in Appendix II enclosed herewith to the Ministry of Health;
b) By the 15th of January, submit a
report on export and import of narcotic drugs, psychotropic drugs, precursor
drugs and medicinal materials that are narcotic drug substances, psychotropic
drug substances, and precursors of facilities in their provinces according
to Form No. 09 in Appendix II enclosed herewith to the Ministry of Health.
4. Within 48 hours from discovery of a mistake or
loss of radiopharmaceuticals, narcotic drugs, psychotropic drugs, precursor
drugs; medicinal materials that are radioactive substances, narcotic drug
substances, psychotropic drug substances, and precursors, the business facility
shall prepare a written report using Form No. 07 in Appendix II enclosed
herewith and send it to the People’s Committee of the province where the head
office is located.
5. In the case where a business facility placed
under control fails to submit reports in accordance with Clauses 1, 2, and 4 of
this Article, its applications for purchase, export, or import of drugs and medicinal
materials shall be suspended from processing until the facility submits reports
as requested.
Article 36. Destruction of
controlled drugs
1. An establishment that wishes to destroy narcotic
drugs, psychotropic drugs, precursor drugs; medicinal materials that are
radioactive substances, narcotic drug substances, psychotropic drug substances,
and precursors shall:
a) submit a notice of time to destroy drugs
and medicinal materials and the list of drugs and medicinal materials to be
destroyed to the competent authority in accordance with Clause 2 hereof. The
head of the establishment shall establish a drug destruction council. The
council consists of at least 03 members, one of which has to be the
establishment’s chief pharmacist. The council shall organize the destruction,
decide the destruction method and supervise the destruction process;
b) The destruction must be witnessed by
representatives of the competent authority specified in Clause 2 hereof and be
recorded using form No. 10 in Appendix II attached hereto. The establishment is
responsible for the destruction of drugs and medicinal materials; ensuring
measures against loss of drugs and medicinal materials after the destruction;
and ensuring compliance with regulations on environmental protection during the
destruction process.
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2. The following authorities shall receive
destruction records of narcotic drugs, psychotropic drugs, precursor drugs;
medicinal materials that are radioactive substances, narcotic drug substances,
psychotropic drug substances, and precursors:
a) Ministry of National Defense, Ministry of Public
Security for facilities under their management except for pharmacy business
establishments;
b) The People's Committee of the province where the
pharmacy business establishment is located, including those under the
management of the Ministry of Public Security, Ministry of National Defense;
c) The People's Committee of the province where the
pharmacy business establishment is located for those not falling under the
cases specified in points a and b hereof.
3. Radiopharmaceuticals; radioactive substances;
primary packages of Radiopharmaceuticals, radioactive substances that are no
longer in use must be stored, preserved, and processed according to atomic
energy laws.
4. Waste from radiopharmaceuticals, radioactive
substances shall be managed in accordance with atomic energy laws.
5. In cases of destruction of residues, by-products
containing narcotic drug substances, psychotropic drug substances, and
precursors used in the production process; combination drugs containing
narcotic drug substances, psychotropic drug substances, or precursors; primary
packages of narcotic drugs, psychotropic drugs, precursors, narcotic drug
substances, psychotropic drug substances, and precursors that are no longer in
use; toxic drugs, toxic medicinal materials, banned drugs and drug substances
in the list of banned substances in the certain fields, the establishment
shall:
a) collect all residues, by-products, drugs,
medicinal materials, primary packages and store them in a designated storage
area as prescribed; ensure security to prevent loss during storage;
b) establish a drug destruction council consisting
of at least 03 members, one of which has to be the establishment’s chief
pharmacist. The council shall organize the destruction, decide the destruction
method and supervise the destruction process;
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6. For narcotic drugs, psychotropic drugs,
precursor drugs in the form of unused solution in the smallest packaging unit
shall to be destroyed, the establishment shall prepare a record specifying the
condition of the drugs at the time of receipt and storage in the designated
storage area as prescribed, ensure security to prevent loss during storage.
During the drug destruction, the drug destruction council shall make a record
at the destruction time and follow the destruction procedures in accordance
with Clause 1 and 2 or Clause 5 of this Article.
Article 37. Procedures for
granting permission for trading in controlled drugs
1. An establishment that wishes to be issued with
the Certificate of eligibility for pharmacy business specified in Article 20
and requests for the permission for trading controlled drugs shall submit the
following documents in addition to the documents hereof:
a) Explanatory documents proving that the
establishment has taken measures to ensure security and prevent loss of
controlled drugs according to Form No. 11 in Appendix II attached hereto;
b) The list of drugs and concoction thereof if the
applicant is the retailer being a pharmacy that concocts controlled drugs
according to prescriptions;
c) Only 01 set of documents specified in this
Clause is required.
2. In the case where the establishment has been
issued with the Certificate of eligibility for Pharmacy Business and requests
for the permission for trading controlled drugs, it shall prepare the
application specified in Clause 1 of this Article.
3. Procedures for granting permission for trading
in controlled drugs :
a) For cases specified in Clause 1 hereof, the
procedures for issuing a Certificate of Eligibility for Pharmaceutical Business
are specified in Article 21 hereof;
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Article 38. Applications for
permission to purchase narcotic drugs, psychotropic drugs, precursor drugs or
medicinal materials that are narcotic drug substances,
psychotropic drug substances, or drug precursors; applications for
permission to sell medicinal materials that are narcotic drug substances,
psychotropic drug substances, 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. 12 in Appendix
II enclosed with Form No. 13 in Appendix II hereof;
b) A written explanation for purchasing and
inventory of drugs that exceeds 150% of the
total business demand; for pharmacy business establishments, a successful bid
result or successful bid and a purchase order specifying the name and quantity
of the drugs must be provided. The establishment must provide a projected
business plan for the drugs being purchased for the first time.
2. An application for permission to purchase
medicinal materials that are narcotic drug substances, psychotropic drug
substances or drug precursors consists of:
a) 01 copy of the order for medicinal materials
that are narcotic drug substances, psychotropic drug substances or drug
precursors made using Form No. 12 in Appendix II attached herewith;
b) A report on use of medicinal materials
made using Form No. 05 in Appendix II attached herewith;
c) 01 copy of the order for medicinal materials
that are narcotic drug substances, psychotropic drug substances or drug
precursors made using Form No. 13 in Appendix II attached herewith;
d) A plan for manufacture of drugs from the
materials to be purchased;
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3. An application for permission to transfer
medicinal materials that are narcotic drug substances, psychotropic drug
substances or drug precursors consists of:
a) Form No. 14 in Appendix II attached hereto and a
plan to use medicinal materials prepared by the receiving establishment;
b) 01 original copy of the Transfer Order for
medicinal materials that are narcotic drug substances, psychotropic drug
substances or drug precursors made using Form No. 12 in Appendix II attached
hereto;
c) Report on the use of medicinal materials made
using Form No. 05; Report on the import-export-stock of medicinal materials
made using Form No. 13 in Appendix II attached hereto.
4. Only 01 set of documents specified in Clause 1,
2, 3 of this Article is required.
Article 39. Procedures for
granting permission to purchase narcotic drugs, psychotropic drugs,
precursor drugs or medicinal materials that are narcotic drug substances,
psychotropic drug substances, or drug precursors; procedures for granting
permission to sell medicinal materials that are narcotic drug substances, psychotropic drug
substances, or drug precursors
b) The Ministry of National Defense for the
purchase of drugs from facilities affiliated to the Ministry of National
Defense, excluding pharmacy business establishments;
c) The Ministry of Public Security for the purchase
of drugs from facilities affiliated to the Ministry of Public Security,
excluding pharmacy business establishments;
d) The People's Committee of the province where the
business is located for the purchase of drugs from pharmacy business
establishments, including those under the management of the Ministry of Public
Security and the Ministry of National Defense.
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2. The receiving authority shall issue an
application receipt form made using Form No. 01 in Appendix I attached herewith
to the applicant.
3. If the application is satisfactory, the
receiving authority shall issue a written permission within 30 working days
from the date indicated on the application receipt form.
4. If the application is not satisfactory, the
receiving authority shall, within 30 working days from the date indicated on
the application receipt form, request the applicant to complete the application
and specify necessary additional documents according to Form No. 16 in
Appendix I attached herewith.
5. After receiving the supplemented application,
the receiving authority shall issue an application receipt form made using Form
No. 01 in Appendix I attached herewith to the applicant.
a) If the supplemented application is still
unsatisfactory, the receiving authority shall, within 30 working days from the
date indicated on the application receipt form, notify the applicant in writing
according to Form No. 16 in Appendix I attached hereto regarding the
non-approval of the Order;
b) If the supplemented application is satisfactory,
the receiving authority shall issue a written permission 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 receiving authority, the
applicant shall submit additional documents as requested. If the applicant
fails to satisfy such request by the aforementioned deadline, the submitted
application will be invalid.
Article 40. Procedures for
granting permission to retail drugs on the list of drugs restricted from
retailing
1. If the applicant applies for the Certificate of
eligibility for pharmacy business that allows drug retailing on the list of
drugs restricted from retailing:
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b) Procedures for granting permission to retail drugs
on the list of drugs restricted from retailing shall comply with Article 21
hereof.
2. If the applicant has obtained the Certificate of
eligibility for pharmacy business:
a) The applicant shall submit 01 copy of Form No.
12 in Appendix II enclosed herewith for adjustment of the Certificate of
eligibility for pharmacy business with the request to retail drugs on the list
of drugs restricted from retailing;
b) Procedures for granting permission to retail
drugs on the list of drugs restricted from retailing shall comply with Article
22 hereof.
Section 5. PHARMACEUTICAL
BUSINESS BY E-COMMERCE METHOD
Article 41. Disclosure of
information when conducting pharmaceutical business by e-commerce method
1. Pharmacy business facilities shall disclose the
following information when conducting pharmaceutical business by e-commerce
method:
a) Information regarding the Certificate of
eligibility for pharmacy business, including: business name, business address,
license number, date of issuance, and issuing authority;
b) Information about the pharmacy practice
certificate of the chief pharmacist, including: full name, pharmacy practice
certificate number, date of issuance, and issuing authority;
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2. Regulations on information disclosure:
a) Information specified in points a and b, Clause
1 hereof shall be posted on e-commerce applications or websites
(hereinafter referred to as “e-commerce websites"), the store the
pharmacy business facility on e-commerce platforms;
b) Information about drugs specified in point c of
Clause 1 hereof must be posted in a separate section and must not be mixed with
information about products other than drugs;
c) Information and images posted as specified in
Clause 1 hereof must be presented fully, clearly, easy-to-read;
d) For pharmacy chains, the contents specified in
Clause 1 hereof must include information about both the pharmacy chain and
pharmacies within the pharmacy chains participating in e-commerce business;
dd) Pharmacy establishments are responsible for the
accuracy and legitimate of information and images provided.
Article 42. Pharmaceutical
business on e-commerce platforms
1. Establishments selling drugs and medicinal
materials shall provide the Certificate of eligibility for pharmaceutical
business, information about marketing authorization or import license of drugs
and medicinal materials to traders, e-commerce trading service providers to
conduct inspections and supervision before registering to use services on the
trading platform.
2. The information printed on the packages of goods
sent to customers in case of retailing drugs must include the name, address,
phone number of the customer, and the phone number of the advisor.
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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 43. Requirements and
application for export license for narcotic drugs, psychotropic drugs,
precursor drugs, medicinal materials that are narcotic drug substances,
psychotropic drug substances or drug precursors or combination drugs that
contain narcotic drug substances, combination drugs that contain psychotropic
drug substances 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. A medicinal material shall only be licensed to
export when one of the following requirements is satisfied:
a) The material 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; or
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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 the competent authority. If the
import license is written in a language other than Vietnamese or English
language, a notarized Vietnamese or English translation shall be included. In
cases where the importing country does not require a license to import
drugs/medicinal materials, the exporter shall provide a document issued by
competent authorities to verify such regulations of the importing country.
The import license and documents
aforementioned shall be consularly
legalized in accordance with regulations 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 44. Requirements and
application for license to export radiopharmaceuticals, radioactive substances
used in medicine; drugs or drug substances on the list of banned
substances in certain fields; toxic drugs or toxic medicinal materials
1. A drug or medicinal material shall only be
licensed to export 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:
03 original copies of the purchase order according
to Form No. 04 or Form No. 05 in Appendix III enclosed herewith;
3. Only 01 set of documents specified in this
Article is required.
Article 45. Requirements and
application for 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 copy of the purchase order according
to Form No. 6 in Appendix III enclosed herewith;
b) A copy of the Certificate of eligibility for
pharmacy business 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) In case of export for non-commercial purposes,
the documents specified in Points b and c of this Clause are not required.
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Article 46.
Licensing non-commercial export of controlled drugs
1. The non-commercial export of a controlled drug
shall be granted when the drug is granted a marketing authorization in
Vietnam and satisfy one of the following requirements:
a) The drug is personal property sending under
a shipping document or belongings of individuals or organizations exiting
Vietnam for medical treatment, 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 used.
2. The marketing authorization must be obtained
before drugs are exported, except for those mentioned in point a Clause 1
of this Article if the quantity does not exceed:
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 drug substances, combination drugs that contain psychotropic drug
substances and combination drugs that contain precursors, toxic drugs, drugs
and drug substances on the list of banned substances in certain fields
according to the prescription.
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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 or
seal. 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) If any of the documents mentioned in point b of
this Clause is written in a language other than Vietnamese or English language,
a notarized Vietnamese or English translation shall be included.
4. An application for export of the drug mentioned
in point b Clause 1 of this Article:
a) 03 original copy of the purchase order according
to Form No. 01 or Form No. 04 in Appendix III enclosed herewith;
b) 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;
c) 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 AIPs,
combination drugs that contain psychotropic AIPs and combination drugs that
contain precursors;
d) If any of the documents mentioned in point b and
point c 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.
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a) 03 original copy of the purchase order according
to Form No. 01 or Form No. 04 in Appendix III enclosed herewith;
b) A report on quantity of drugs used for humanitarian
medical services according to Form No. 08 in Appendix III enclosed herewith.
6. Only 01 set of documents specified in Clause 3,
4, 5 of this Article is required.
Article 47. Requirements and
application for export of controlled drugs for exhibition
1. The export of a narcotic drug, psychotropic
drug, precursor drug, narcotic AIP, psychotropic AIP, drug precursor,
combination drug that contains narcotic drug substances, combination drug that
contains psychotropic drug substances or combination drug that contains
precursors shall only be licensed when one of the following requirements is
satisfied:
a) The material 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; 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. An application for export of a narcotic drug,
psychotropic drug, precursor drug, narcotic AIP, psychotropic AIP, drug
precursor, combination drug that contains narcotic drug substances, combination
drug that contains psychotropic drug substances 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;
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The import license and documents
aforementioned shall be consularly legalized in accordance with
regulations 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 drug substances on the list
of substances banned from certain fields for exhibition shall comply with
regulations of law on temporary export of goods.
Article 48. Requirements and
application for export of controlled drugs for the purpose of clinical trial,
bioequivalence study, bioavailability assessment, testing, scientific research
or as specimens for registration
1. The export of a narcotic drug, psychotropic
drug, precursor drug, narcotic AIP, psychotropic AIP, drug precursor,
combination drug that contains narcotic drug substances, combination drug that contains
psychotropic drug substances or combination drug that contains precursors shall
only be licensed when one of the following requirements is satisfied:
a) The material 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; 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. An application for export of a narcotic drug,
psychotropic drug, precursor drug, narcotic AIP, psychotropic AIP, drug
precursor, combination drug that contains narcotic drug substances, combination
drug that contains psychotropic drug substances 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;
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The import license and documents
aforementioned shall be consularly legalized in accordance with
regulations 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 export of a radiopharmaceutical, toxic drug,
toxic medicinal material, drug or DRUG SUBSTANCE on the list of drugs and drug
substances banned from certain fields 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
b) The drug or material is manufactured overseas
and has been granted a marketing authorization in Vietnam.
4. An application for export radiopharmaceuticals,
radioactive substances used in medicine; drugs or drug substances on the
list of banned substances in certain fields; toxic drugs or toxic
medicinal materials includes: 01 original copies of the purchase order
according to Form No. 04 or Form No. 05 in Appendix III enclosed herewith;
Article 49. Procedures and
time limit for licensing export of controlled drugs, herbal materials on the
list of If the application is satisfactory, 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 specified in Articles 43,
44, 45, points b and c Clause 1 Article 46, Clause 1 Article 47 and Article 48
hereof:
a) The applicant shall submit an application
directly or by post or online to the Ministry of Health or the People's
Committee of the province where the head office is located in accordance with
procedures specified in Article 123 hereof.
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b) After receiving the application, the receiving
authority shall give the application receipt form made using form No. 01 in
Appendix I enclosed herewith to the applicant;
c) If the application is satisfactory, the
receiving authority shall issue the export license within 10 working days from
the date indicated on the application receipt form;
d) If the application is not satisfactory, the
receiving authority shall, within 07 working days from the date indicated on
the application receipt form, request the applicant in writing to complete it
according to form No. 01 in Appendix I enclosed herewith;
dd) After receiving the supplemented application,
the receiving authority shall give the application receipt form made using form
No. 01 in Appendix I enclosed herewith to the applicant; If the supplemented
application is not satisfactory, the receiving authority shall, within 07
working days from the date indicated on the application receipt form, respond
in writing and specify the reasons regarding non-issuance of export license
according to form No. 01 in Appendix I enclosed herewith; If the supplemented
application is satisfactory, the receiving authority 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 receiving authority, the
applicant shall submit additional documents as requested. If the applicant
fails to submit supplemented application, the application will be rejected.
2. Procedures and time limit for issuing the export
licenses in the case specified in point a Clause 1 Article 60 hereof:
a) The applicant shall submit an application,
directly or by post or online, to the People's Committee 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 People's Committee
of the province shall give the application receipt form made using form No. 01
in Appendix I enclosed herewith to the applicant;
c) If the application is satisfactory, the People's
Committee of the province shall issue the export license within 10 working days
from the date indicated on the application receipt form;
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dd) After receiving the supplemented application,
the People's Committee of the province shall give the application receipt form
made using form No. 01 in Appendix I enclosed herewith to the applicant; If the
supplemented application is not satisfactory, the People's Committee of the
province shall, within 05 working days from the date indicated on the
application receipt form, respond in writing and specify the reasons regarding
non-issuance of export license according to form No. 01 in Appendix I enclosed
herewith; If the supplemented application is satisfactory, the People's
Committee of the province 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 People's Committee of the
province, the applicant shall submit additional documents as requested. If the
applicant fails to submit supplemented application, the application will be
rejected.
3. Within 03 days from the day on which the export
license is issued, the competent authority shall publish information about the
permission for export of the herbal materials on the list of controlled rare
and special herbs on its website.
4. The export license shall be made using Form
No. 09, 10, 11, 12, 13 in Appendix III enclosed herewith.
Article 50. 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 drug substances,
combination drugs that contain psychotropic drug substances, combination drugs
that contain precursors or medicinal materials that are narcotic drug
substances, psychotropic drug substances 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 drug
substances, combination drugs that contain psychotropic drug substances,
combination drugs that contain precursors or medicinal materials that are
narcotic drug substances, psychotropic drug substances or drug precursors,
herbal materials on the list of controlled precious, rare and endemic medicinal
material species and varieties other than those specified in point a Clause 1
Article 46 hereof may only be exported through international checkpoint.
4. A manufacturer of narcotic drugs, psychotropic
drugs, precursor drugs, medicinal materials that are narcotic drug substances,
psychotropic drug substances or drug precursors may export the drugs or
medicinal materials it manufactures.
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6. The applicant for permission for non-commercial
export of controlled drugs specified in point a Clause 1 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 drug substances, psychotropic drug substances or drug precursors or
combination drugs that contain narcotic drug substances, combination drugs that
contain psychotropic drug substances and combination drugs that contain
precursors that were temporarily exported for exhibition.
Section 2. IMPORT OF DRUGS
WITHOUT THE MARKETING AUTHORIZATION IN VIETNAM
Article 51. Requirements and
application for licensing import of drugs containing drug substances 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) 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) 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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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 or a
copy accompanied by the original for verification 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) 01 set of label and package insert from the drug
manufacturing country or the exporting country, bearing the seals of by the
manufacturer or product owner or product license holder (as specified in
the Certificate of Pharmaceutical Product) and the importer (the color print of
the package insert in the home country is accepted);
dd) 02 sets of label intended to be used in Vietnam
and the package insert in Vietnamese language which bear the importer’s seal;
e) Clinical data about the safety and efficacy of
the drug according to the regulations on drug registration of the Minister of
Health, including the requirement for Phase 3 clinical data.
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;
g) A sale report made using 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 drug substances, combination drug that contains psychotropic drug substances,
combination drug that contains precursors;
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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.
3. Only 01 set of documents specified in this
Article is required.
Article 52. Requirements and
application for licensing import of drugs containing drug substances 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 or a country that is a 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 or a
copy accompanied by the original for verification of the certificate of
pharmaceutical product;
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d) 01 set of label and package insert from the drug
manufacturing country or the exporting country, certified by the manufacturer
or product owner or product license holder (as specified in the
Certificate of Pharmaceutical Product) and the importer (the color print of the
package insert in the home country is accepted);
dd) 02 sets of label intended to be used in Vietnam
and the package insert in Vietnamese language which bear the importer’s seal;
e) Clinical document if required by 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 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.
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 made using 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 drug
substances, combination drug that contains psychotropic drug substances,
combination drug that contains precursors;
i) The original copy or certified true copy or copy
accompanied by the original for verification of the GMP certificate or
the manufacturing license of all facilities participating in the
manufacture of the imported drug. In case where the competent authority does
not issue a GMP certificate or manufacturing license, the importer shall submit
the original copy or certified true copy or copy accompanied by the original
for verification of inspection report on Good Manufacturing Practice of the
most recent inspection of all facilities participating in the manufacture of
the imported drug.
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.
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 drug must be granted a marketing
authorization in at least one country worldwide.
b) The import must meet urgent need of national
defense and security, epidemic control or disaster relief.
2. An application for the import license for drugs
to meet urgent need of national defense and security includes:
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 or copy
accompanied by the original for verification of the certificate of
pharmaceutical product or a confirmation of marketing authorization in at least
one other country issued by the exporting country’s competent authority;
c) An original copy or a copy bearing the
issuer’s seal of the written request regarding the import of drugs to meet
urgent need of national defense issued by the Ministry of National Defense or
the approval on import of drugs to meet urgent need of security issued by the
Ministry of Public Security. The written request must include: the active
ingredients of the modern drug or biologicals or herbal materials of the herbal drug or traditional drug, dosage
form, concentration of drug substances 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. An application for license to import drugs to
meet urgent need of epidemic control or disaster relief, except in cases
specified in Clause 4 of this Article, includes:
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) An original copy of the authorization letter of
the manufacturer or the holder of the marketing authorization on the
Certificate of Pharmaceutical Product for the applicant in Vietnam, in cases
where the importer is not the manufacturer or the holder of the marketing
authorization on the Certificate of Pharmaceutical Product;
d) 01 set of label and package insert from the drug
manufacturing country or the exporting country, certified by the manufacturer
or product owner or product license holder (as specified in the Certificate
of Pharmaceutical Product) and the importer (the color print of the package
insert in the home country is accepted);
dd) Quality documents;
e) Clinical documents;
g) The original copy or certified true copy or copy
accompanied by the original for verification of the GMP certificate or
the manufacturing license of all facilities participating in the
manufacture of the imported drug. In case where the competent authority does
not issue a GMP certificate or manufacturing license, the importer shall submit
the original copy or certified true copy or copy accompanied by the original
for verification of inspection report on Good Manufacturing Practice of the
most recent inspection of all facilities participating in the manufacture of
the imported drug.
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.
4. An application for license to import drugs to
meet urgent need of epidemic control or disaster relief with a written approval
issued by the Ministry of Health includes:
a) documents specified in points a and b Clause 3
hereof;
b) An original copy or a copy of the written
approval of the Ministry of Health for urgent needs of epidemic control or
disaster relief including: the active ingredients of the modern drug or
biologicals or herbal materials of the herbal drug or traditional drug, dosage
form, concentration of drug substances of the modern drug or biologicals or
quantity of herbal materials of the herbal drug or traditional drug, package
contents, manufacturer and manufacturing country.
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Article 53. Requirements and
application for licensing import of drugs for special treatment
1. The import of a drug (excluding vaccines) shall
only be licensed when the following requirements are satisfied:
It is a drug (excluding vaccines) imported to meet
the need of special treatment when there is no drug that has the same active
ingredients, concentration, and dosage form having the marketing authorization
in Vietnam, or when a drug granted a marketing authorization in Vietnam is not
sufficient to meet the treatment needs, or when a drug granted a marketing
authorization differs in treatment from a drug which has been granted a
marketing authorization in Vietnam, and falls under one of the following cases:
a) It is used for purposes of emergency, antidote,
transplant rejection prevention, or falls under the list of rare medicines;
b) It is included in the shock prevention and
management issued and approved by the Ministry of Health;
c) It is used for specific patients undergoing
treatment at healthcare and medical facilities for diagnosis, prevention, or
treatment of Group A infectious diseases; cancer; HIV/AIDS; tuberculosis;
malaria; and other severe diseases as determined by the Minister of Health;
d) It is used to treat diseases listed in the rare
disease list issued by the Minister of Health.
2. The import of a vaccine shall only be licensed
when the following requirements are satisfied: it is a vaccine for a disease
not present in Vietnam and for which there is no vaccine of the same type
granted a marketing authorization in Vietnam, to meet the vaccination needs of
individuals traveling to countries or territories where these diseases exist.
3. Application for the import license:
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b) Documents proving the quality, safety and
efficacy of the vaccine for the cases specified in Clause 2 hereof.
Documents specified in this point are not required
to be submitted in cases where the vaccine has been prequalified by the World
Health Organization (hereinafter referred to as “WHO”)
Documents proving the quality, safety and efficacy
of the vaccine are not required to be submitted in cases where the vaccine is
classified as a rare drug;
c) An original copy of the document of the
healthcare and medical facility which contains the reason for importing the
drug, the quantity of patients who need to use it and quantity of drug needed,
and the commitment to assume responsibility for the use of the imported drug;
an original copy of the document of the vaccination center which contains the
reason for importing the vaccine, the quantity of persons who need to use it
and quantity of vaccine needed, and the commitment to assume responsibility for
the use of the imported vaccine. The document shall be enclosed with the
original copy or the copy bearing the seal of the healthcare and medical
facility and a minutes of meeting of the Drug and Treatment Council about the
import demand of such drug. In cases where the vaccination center does not have
a Drug and Treatment Council, or the drug used for the emergency or poison
control is needed for patients who are clearly listed by the healthcare and
medical facility, the minutes of meeting are not required.
d) The list of drugs to be imported according to
Form No. 19, 20 or 21 in Appendix III enclosed herewith;
dd) A report on drugs to be imported 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 vaccine
supplied to the Vietnamese importer according to Form No. 23 in Appendix III
enclosed herewith;
g) The drug provider is not required to comply with
Article 78 hereof if it has a copy of the Pharmacy Business License which is
issued by the competent agency of the home country and is certified and
consularly legalized according to the regulations.
4. Only 01 set of documents specified in Clause 3
of 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) It is on the list of rare drugs;
b) 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 or a
copy accompanied by the original for verification 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) 01 set of label and package insert from the drug
manufacturing country or the exporting country, certified by the manufacturer
or product owner or product license holder (as specified in the
Certificate of Pharmaceutical Product) and the importer (the color print of the
package insert in the host country is accepted);
dd) 02 sets of label intended to be used in Vietnam
and the package insert in Vietnamese language which bear the importer’s seal;
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g) The original copy or certified true copy or copy
accompanied by the original for verification of the GMP certificate or
the manufacturing license of all facilities participating in the
manufacture of the imported drug. In case where the competent authority does
not issue a GMP certificate or manufacturing license, the importer shall submit
the original copy or certified true copy or copy accompanied by the original
for verification of inspection report on Good Manufacturing Practice of the
most recent inspection of all facilities participating in the manufacture of
the imported drug.
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.
3. Only 01 set of documents specified in this
Article is required.
Article 56. Requirements and
application for licensing drugs that have the same trade name, active
ingredients, concentration or dosage form as the brand-name drug having
the marketing authorization in Vietnam, are manufactured by the same
manufacturer of the brand-name drug or by an authorized manufacturer, and are
sold at a lower price than that of the 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 point dd Clause 2 Article 60 of
the Law on Pharmacy;
b) The expected wholesale price is lower by at
least 20% than the successful bid price for the original brand-name drug having
the marketing authorization in Vietnam;
c) The drug is licensed and exported to Vietnam
from the manufacturing country or from a country that is a member state of the
ICH or from Australia;
d) The drug is not a radiopharmaceutical, vaccine
or biological.
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a) 03 original copies of the purchase order
according to Form No. 15, 16 or 17 in Appendix III enclosed herewith;
b) Documents proving that the drug is lawfully
marketed in the manufacturing country or a reference country;
c) 01 set of label and package insert from the drug
manufacturing country or the exporting country, certified by the manufacturer
or product owner or product license holder (as specified in the Certificate of
Pharmaceutical Product) and the importer (the color print of the package insert
in the host country is accepted);
d) 02 sets of secondary label and the package
insert in Vietnamese language which bears 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.
Article 57. Requirements and
application for licensing import of drugs as emergency aid or humanitarian aid
1. The import of such a drug shall only be licensed
when the following requirements are satisfied:
The drug is licensed in the manufacturing country
or a country that is a member state of the ICH or Australia, and falls under
one of the following cases
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) 03 original copies of the purchase order
according to Form No. 24, 25 or 26 in Appendix III enclosed herewith;
b) The original document clearly states the
quantity of each type of drugs received as emergency aid or humanitarian aid,
and written commitment to using drugs for the intended purposes and target
population of the receiving facility.
c) The original copy or the certified true copy of
the written approval issued by a competent authority for the acceptance of
emergency aid or humanitarian aid or the original copy of the written approval
issued by a competent authority for the humanitarian examination and treatment
and the list of aid drugs in the cases of import in accordance with point 1
Clause 1 hereof;
d) The original copy or a certified true copy or a
copy accompanied by the original for verification of the certificate of
pharmaceutical product;
dd) Quality documents according to the regulations
of the Minister of Health on the use of ACTD or the ICH-CTD in drug
registration or quality standards and results of bioequivalence study according
to Clause 6 Article 61 hereof;
e) Clinical document if requested by of the
Minister of Health on drug registration.
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g) 01 set of label and package insert from the drug
manufacturing country or the manufacturing country, certified by the
manufacturer or product owner or product license holder (as specified in the
Certificate of Pharmaceutical Product) and the importer (the color print of the
package insert in the home country is accepted);
h) 02 sets of label intended to be used in Vietnam
and the package insert in Vietnamese language which bear the importer’s seal;
i) The original copy or certified true copy or copy
accompanied by the original for verification of the GMP certificate or
the manufacturing license of all facilities participating in the
manufacture of the imported drug. In case where the competent authority does
not issue a GMP certificate or manufacturing license, the importer shall submit
the original copy or certified true copy or copy accompanied by the original
for verification of inspection report on Good Manufacturing Practice of the
most recent inspection of all facilities participating in the manufacture of
the imported drug.
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.
k) Documents specified in points d, dd, e, g, h,
and I hereof are exempted for cases of importing drugs in accordance with
points a and b, Clause 1 hereof. However, the facility receiving humanitarian
aids must provide a written commitment about the drug licensed in the
manufacturing country or the member state of ICH or Australia and the list of
patients in need of the drug according to point b Clause 1 hereof.
3. Only 01 set of documents specified in this
Article is required.
Article 58. Requirements and
application for import of controlled drugs for the purpose of clinical trial,
bioequivalence study, bioavailability assessment, testing, scientific research
or as specimens for registration
1. The import of such a drug shall only be licensed
when one of the following requirements is satisfied:
b) The drug is used for bioequivalence study or
bioavailability assessment in Vietnam under an approved research protocol
according to Clause 1 Article 100 of the Law on Pharmacy
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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 or copy
accompanied by the original for verification of the written approval issued by
a competent authority or organization in the cases mentioned in points a, b,
and dd Clause 1 of this Article;
c) The original copy or certified true copy or copy
accompanied by the original for verification 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 point c Clause 1 of this Article;
d) The explanatory document bearing the importer’s
seal specifying the purposes and quantity of imported drugs and commitment to
use the drugs for intended purposes;
3. Only 01 set of documents specified in this
Article is required.
Article 59. Requirements and
application for import of controlled drugs for exhibition
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a) The drug is only 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.
2. Application for the import license: 03 original
copies of the purchase order according to Form No. 15, 16 or 17 in Appendix III
enclosed herewith;
3. Only 01 set of documents specified in this
Article is required.
4. The drugs specified in this Article shall comply
with regulations of law on temporary import of goods.
Article 60. Requirements and
application for licensing non-commercial import of drugs according
to point i Clause 2 Article 60 of the Law on Pharmacy, unless the drug is
imported to meet the need of special treatment of a healthcare and medical
facility
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 property of an individual
entering Vietnam which is sent under a shipping document or belonging of
an individual entering Vietnam 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.
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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.
c) The quantity of the drug to be imported which is
not a narcotic drug, psychotropic drug or precursor drug does not exceed 30
days’ dose for according to the prescription;
3. Application for the import license:
a) Form No. 27 in Appendix III enclosed herewith;
b) A certified true copy or a copy bearing the
applicant’s signature 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 is
submitted, the original copy shall be produced for comparison when the
application is submitted;
These documents are not required in the case
specified in point b Clause 1 hereof.
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Article 61. Documents in the
application for licensing import of drugs.
1. In the cases of drug import specified in
Articles 51, 52, and 55 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) Name of drug;
b) Dosage form and route of administration;
c) Concentration/content of drug substances of
liquid and semi-solid drugs;
d) Quality standards;
dd) Expiration date;
e) Name and address of the manufacturer.
2. If any of the documents 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) Certificate of Pharmaceutical Product;
b) The Certificate of GMP or manufacturing license
or inspection report on GMP.
4. A certificate of pharmaceutical product
shall satisfy the following requirements, except for drugs imported to meet
urgent need of national defense and security, epidemic control or disaster
relief specified in Article 53 hereof:
a) Requirements specified in Clauses 2, 3, and 5
hereof;
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,
in cases where the certificate of pharmaceutical product is an electronic
version without the signer’s signature, name, or issuer’s seal.
d) The certificate of pharmaceutical product
undergoing consular legalization is the original copy;
dd) It is certified that the drug is
licensed 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;
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h) The certificate of pharmaceutical product in
electronic form, which is published on websites or English-language databases
of overseas competent authorities or on websites or English-language databases
operated by regional drug regulatory authorities, is accepted, regardless of
whether it includes the signer’s signature, name, or issuer’s seal.
If the certificate of pharmaceutical product is
issued in electronic form, the importer must submit the original copy or
certified true copy of the certificate of pharmaceutical product which is
issued by overseas competent authorities and consularly legalized or provide the
result of searching for the certificate that bears the issuer’s seal and a
document providing information on reference links to the Ministry of Health.
In cases where legal documents cannot be retrieved,
the importer must submit a document providing official contact information
(phone number, email) of the issuer for the Ministry of Health for direct
verification.
5. Legal documents in the application must be
unexpired when the application is submitted (indicated on the application
receipt form).
6. Quality standards, drug testing method and
results of the bioequivalence study:
a) Copies which bear the seal of the manufacturer
or the owner of the product or the product license holder (specified in 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 manufactured and licensed (specified on the
Certificate of Pharmaceutical Product) in the country that is the permanent
member or founder of ICH or Australia.
Article 62. Authority,
procedures and time limits for licensing import of drugs without the marketing
authorization in Vietnam
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a) The Ministry of Health shall license import of
drugs for cases of drug import specified in Articles 51, 52, 53, 54, 55, and 56
hereof, unless otherwise provided by law;
b) The Ministry of Health or the People's Committee
of the province where the head office is located in accordance with procedures
specified in Article 123 hereof shall license import of drugs for cases of
drug import specified in Articles 57, 58, and 59 hereof;
c) The People's Committee of the province where the
entry checkpoint is located or where the patient is residing or where the
applicant’s headquarters are located shall license import of drugs for cases of
drug import specified in Article 60 hereof;
d) The Ministry of Health or the People's Committee
of the province shall establish an advisory council for giving counsel on
issuance of the pharmacy practice certificate in accordance with Articles 51,
52, Clause 3 Article 53, Article 55, and points c, d Clause 1 Article 57
hereof.
2. Procedures and time limits for issuance of
import licenses in the cases of drug import specified in Articles 51, 52, 55,
and points c, d Clause 1 Article 57 hereof:
a) The applicant shall submit an application
directly or by post or online to the Ministry of Health in the cases of drug
import specified in Articles 51, 52, and 55 hereof.
The applicant shall submit an application directly
or by post or online to the Ministry of Health or the People's Committee of the
province where the head office is located in accordance with procedures
specified in Article 123 hereof the cases of drug import specified in
points c, d Clause 1 Article 57 hereof;
b) After receiving the application, the receiving
authority shall give the application receipt form made using form No. 01 in
Appendix I enclosed herewith to the applicant;
c) In cases of drug import specified
in Articles 51, 52, and 55 hereof: If the application is satisfactory, the
Ministry of Health shall issue the import license within 60 days from the date
indicated on the application receipt form if clinical documents and documents
proving equivalence to reference biologicals are not required; or within 90
days from the date indicated on the application receipt form 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.
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d) If the application is not satisfactory, the
receiving authority shall request the applicant in writing made using Form No.
16 in Appendix I enclosed herewith to complete it within 60 days from the date
indicated on the application receipt form if clinical documents and documents
proving equivalence to reference biological are not required; or within 90 days
from the date indicated on the application receipt form if clinical documents
and documents proving equivalence to reference biologicals are required;
dd) After receiving the supplemented application,
the receiving authority shall give the application receipt form made using form
No. 01 in Appendix I enclosed herewith to the applicant; If the application is
still unsatisfactory, the receiving authority shall notify the applicant in
writing according to Form No. 16 in Appendix I attached hereto regarding the
non-issuance of the import license within 60 days from the date indicated on
the application receipt form if clinical documents and documents proving
equivalence to reference biological are not required; or within 90 days from
the date indicated on the application receipt form if clinical documents and documents
proving equivalence to reference biologicals are required; If the supplemented
application is satisfactory, the receiving authority 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 receiving authority, the applicant
shall submit additional documents as requested. If the applicant fails to
submit supplemented application, the application will be rejected.
g) If the applicant fails to provide documents
specified in points d, dd, e, g, h, and I Clause 2 Article 57 hereof, however,
the drug is imported to meet the treatment needs, the Ministry of Health or the
People's Committee of the province shall consider deciding on the basis of counsel
given by the certification advisory council, commitment that the drug is
licensed in the manufacturing country or in the country that is the permanent
member or founder of ICH or Australia by the aid providing facility, and
commitment to the safety and efficacy of the drug by the receiving facility.
h) The time limit for issuance of import licenses
or notifications for amendments or supplements to applications for new drugs,
rare drugs, prequalified vaccines by WHO, high-tech drugs, drugs that have undergone
clinical trial in Vietnam specified in Articles 51, 52, and 55 of this Decree
shall be reduced by 10 days compared to the time for issuance of import
licenses or notifications for amendments or supplements as specified in points
c, d, and dd of this Clause.
3. Procedures and time limits for issuance of
import licenses in cases of drug import specified in Clauses 2 and 4 Article 53
hereof:
a) The applicant shall submit an application
directly or by post or online to the Ministry of Health;
b) After receiving the application, the Ministry of
Health shall give the application receipt form made using form No. 01 in
Appendix I enclosed herewith to the applicant;
c) If the application is satisfactory, the Ministry
of Health shall issue the export license within 03 working days from the date
indicated on the application receipt form;
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dd) After receiving the supplemented application,
the Ministry of Health shall give the application receipt form made using form
No. 01 in Appendix I enclosed herewith to the applicant; If the supplemented
application is still unsatisfactory, the Ministry of Health shall notify the
applicant in accordance with point d hereof. 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 importer fails to provide documents
specified in point b Clause 2 or point b Clause 3 Article 53 hereof, however,
the drug is imported to meet the prevention and treatment needs, the Minister
of Health shall consider deciding on the basis of the proposal and
responsibility of relevant Ministries.
4. Procedures and time limits for issuance of
import licenses in cases of drug import specified in Clause 3 Article 53
hereof:
a) The applicant shall submit an application
directly or by post or online to the Ministry of Health;
b) After receiving the application, the Ministry of
Health shall give the application receipt form made using form No. 01 in
Appendix I enclosed herewith to the applicant;
c) If the application is satisfactory, within 07
working days from the date indicated on the application receipt form, the
Ministry of Health shall approve the import of drugs to meet urgent need of
national defense and security, epidemic control or disaster relief and issue
the import license on the basis of the application appraisal and counsel given
by the certification advisory council;
d) If the application is unsatisfactory, the
Ministry of Health shall, within 07 working days from the date indicated on the
application receipt form, request the applicant in writing to complete it
according to form No. 16 in Appendix I enclosed herewith;
dd) After receiving the supplemented application,
the Ministry of Health shall give the application receipt form made using form No.
01 in Appendix I enclosed herewith to the applicant; If the supplemented
application is still unsatisfactory, the Ministry of Health shall notify the
applicant in accordance with point d hereof. If the supplemented application is
satisfactory, the Ministry of Health shall approve and issue the import license
in accordance with point c of this Clause;
e) If the importer fails to provide documents
specified in point b Clause 3 Article 53 hereof, however, the drug is imported
to meet the prevention and treatment needs, the Minister of Health shall
consider deciding.
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a) The applicant shall submit an application
directly or by post or online to the Ministry of Health in the cases of
drug import specified in Articles 54 and 55 hereof, unless otherwise provided
by law.
The applicant shall submit an application directly or
by post or online to the Ministry of Health or the People's Committee of the
province where the head office is located in accordance with procedures
specified in Article 123 hereof the cases of drug import specified in
points a, b Clause 1 Article 57, Article 58, and Article 59 hereof;
b) After receiving the application, the receiving
authority shall give the application receipt form made using form No. 01 in
Appendix I enclosed herewith to the applicant;
c) If the application is satisfactory, the receiving
authority shall issue the import license within 15 working days from the date
indicated on the application receipt form;
d) If the application is not satisfactory, the
receiving authority shall, within 15 working days from the date indicated on
the application receipt form, request the applicant in writing to complete it
according to form No. 16 in Appendix I enclosed herewith;
dd) After receiving the supplemented application,
the receiving authority shall give the application receipt form made using form
No. 01 in Appendix I enclosed herewith to the applicant; If the supplemented
application is not satisfactory, the receiving authority shall, within 07
working days from the date indicated on the application receipt form, respond
in writing and specify the reasons regarding non-issuance of import license
according to form No. 16 in Appendix I enclosed herewith; If the supplemented
application is satisfactory, the receiving authority 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 receiving authority, the
applicant shall submit additional documents as requested. If the applicant
fails to submit supplemented application, the application will be rejected.
g) The time limit for issuance of import licenses
or notifications for amendments or supplements to applications for new drugs,
rare drugs, prequalified vaccines by WHO, high-tech drugs, drugs that have
undergone clinical trial in Vietnam specified in Articles 54 and 56 of this
Decree shall be reduced by 5 days compared to the time for issuance of import
licenses or notifications for amendments or supplements as specified in points
c, d, and dd of this Clause.
6. Procedures and time limit for issuing the import
licenses in the cases specified in Article 60 hereof:
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b) After receiving the application, the People's
Committee of the province shall give the application receipt form made using
form No. 01 in Appendix I enclosed herewith to the applicant;
c) If the application is satisfactory, the People's
Committee of the province shall issue the import license within 10 working days
from the date indicated on the application receipt form;
d) If the application is not satisfactory, the
People's Committee of the province shall, within 07 working days from the date
indicated on the application receipt form, request the applicant in writing to
complete it according to form No. 16 in Appendix I enclosed herewith;
dd) After receiving the supplemented application,
the People's Committee of the province shall give the application receipt form
made using form No. 01 in Appendix I enclosed herewith to the applicant; If the
supplemented application is not satisfactory, the People's Committee of the
province shall, within 07 working days from the date indicated on the
application receipt form, respond in writing and specify the reasons regarding
non-issuance of import license according to form No. 16 in Appendix I enclosed
herewith; If the supplemented application is satisfactory, the People's
Committee of the province shall issue the import 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 People's Committee of the
province, the applicant shall submit additional documents as requested. If the
applicant fails to submit supplemented application, the application will be
rejected.
7. Within 05 working days from the day on which the
license for drug import is issued according to Articles51, 52, 53, 54, and 55
hereof, the Ministry of Health shall publish information on its website in
accordance with Clause 6 Article 60 of the Law on Pharmacy.
8. The import license shall be made using Form
No. 28, 29, 30, 31, 32 in Appendix III enclosed herewith.
Article 63. Management of
import of drugs without the marketing authorization in Vietnam
1. The drug without the marketing authorization shall
be granted an import license in accordance with Articles 51, 54, and 55 hereof
as follows:
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b) Drugs imported in accordance with Article 54 of
hereof shall be supplied directly or through wholesalers to healthcare and
medical facilities and vaccination centers specified in the import license or
permission for import, except for the cases of drugs transfer stipulated in
Clause 1 Article 85 hereof.
2. Drugs without the marketing authorization
imported in accordance with Article 56 hereof must undergo quality inspection
by an authority specialized in testing drugs and medicinal materials according
to quality standards applied to brand-name drugs having the marketing
authorization in Vietnam.
3. Healthcare and medical facilities and
vaccination centers using drugs and vaccines imported in accordance with
Article 64 hereof shall inform the users, patients, or patient representatives
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 representatives.
4. Drugs licensed for import to serve health
programs of the State, clinical trial, research or testing shall be used for
intended purposes.
5. Controlled drugs that are licensed for import to
serve provision of humanitarian medical services and are not completely used
shall be re-exported in accordance with Clause 5 Article 46 hereof and must not
be used for any other purpose.
6. Drugs licensed for import to be displayed at a
medical, pharmaceutical or medical device fair according to Article 59 hereof
shall be completely re-exported after the fair is ended and must not be used or
sold in Vietnam.
7. The applicant for permission for non-commercial
import of controlled drugs specified in Article 60 hereof is responsible for
their origin and quality.
8. Within the period of 01 year from the date of
importing drugs without marketing authorization in Vietnam stipulated in
Article 51 hereof, the importer shall submit a report on the use of imported
drugs made using Form No. 48 in Appendix III attached hereto to the Ministry of
Health.
Article 64. Import of drugs to
meet the needs for prevention and treatment of group A infectious diseases that
have been declared as epidemics in accordance with laws on prevention and
control of infectious diseases
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2. The customs authorities shall only allow
clearance of shipments of drugs if the importer provides satisfactory
customs clearance documents as required.
3. Drug importers shall:
a) Report to the Ministry of Health about the
customs declaration registration within 2 working days from the date of customs
declaration registration;
b) Complete the application for permission of drug
import as per the request for modification or supplementation of
documents by the licensing authority;
c) Submit the import license to the customs
authorities within 30 days from the date of customs declaration registration.
If the importer fails to submit the import license within the aforementioned
deadline, the importer shall send a report to the Ministry of Health. The
Ministry of Health shall notify the customs authorities to carry out management
and supervision;
d) Maintain the integrity of the goods and only
circulate the products after clearance and meeting the requirements stipulated
in Article 103 of Low on Pharmacy.
Section 3. IMPORT OF
CONTROLLED DRUGS HAVING THE MARKETING AUTHORIZATION IN VIETNAM, AND CONTROLLED
MEDICINAL MATERIALS
Article 65. Applications 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 drug substances, combination drugs that contain psychotropic drug
substances, 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:
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2. A report on sale of the drug according to Form
No. 18 in Appendix III enclosed herewith, except for toxic drugs.
3. For controlled drugs, except for toxic drugs, 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, a written explanation enclosed with documentary
evidence are required. The written explanation must include approved bidding
results, sales contracts or principle contracts with orders specifying the
name, marketing authorization number, and quantity of the drugs. In the case of
the first-time import, this information may be replaced by the plan for sale of
the imported drug.
4. Only 01 set of documents specified in this
Article is required.
Article 66. Applications for
licensing import of controlled medicinal materials
1. An application for licensing import of controlled
medicinal materials includes:
a) 01 original copy of the purchase order according
to Form No. 35 or 03 original copies of the purchase order according to Form
No. 36 or 03 original copies of the purchase order according to Form No. 41 in
Appendix III enclosed herewith.
b) A copy of the document about the quality
standards and testing method for medicinal materials of the manufacturer which
bears the importer’s seal;
c) A certified true copy of the manufacturing
license of the manufacturer or the Certificate of GMP issued by the overseas
competent authority. 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.
d) A report on the use of medicinal materials
(other than toxic medicinal materials) made using Form No. 37 in Appendix III
attached hereto and a report on the sale of drugs, semi-finished drugs
manufactured from medicinal materials (other than toxic medicinal materials)
made using Form No. 38 in Appendix III attached hereto.
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dd) The plan for manufacture, use, or sale of
imported medicinal materials and the plan for sale of drugs, semi-finished
drugs manufactured from imported medicinal materials other than toxic medicinal
materials.
The plan for sale of finished products manufactured
from imported medicinal materials is not required in cases where medicinal
materials are imported for testing or research.
For controlled medicinal materials other than toxic
medicinal materials, if the total quantity of imported medicinal materials and
remaining medicinal materials specified in the order form and the quantity of
medicinal materials 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, the importer must provide approved bidding results, sales contracts
or principle contracts with orders specifying the name, marketing authorization
number, and quantity of the medicinal materials. This requirement does not
apply to import cases for testing, research, and first-time
imports.
e) Documents specified in points b and c hereof are
not required in the cases where imported medicinal materials are imported for
testing or research; toxic medicinal materials, radioactive substances used in
medicines; drug substances in the list of banned substances in certain fields
imported for manufacturing drugs and semi-finished drugs for the export
purpose; medicinal materials with marketing authorization in Vietnam; or for
the manufacture of drugs, semi-finished drugs with marketing authorization in
Vietnam.
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 is required;
h) In the cases where a controlled medicinal
material is that does not have the marketing authorization in Vietnam or not on
the list of drug substances, 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 is required.
2. If any of the documents mentioned in points b
and c, Clause 1 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
drug substances, psychotropic drug substances or drug precursors for exhibition
shall not be licensed.
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Article 67. 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
directly or by post or online to:
a) the Ministry of Health or the People's Committee
of the province where the head offices is located, according to the procedures specified
in Article 123 of this Decree, for the application for licensing import of
controlled drugs having a marketing authorization in Vietnam;
b) the Ministry of Health, for the
application for licensing import of controlled medicinal materials.
2. After receiving the application, the receiving
authority shall give the application receipt form made using form No. 01 in
Appendix I enclosed herewith to the applicant;
3. If the application is satisfactory, the
receiving authority shall issue the import license within 15 working days from
the date indicated on the application receipt form;
4. If the application is not satisfactory, the
receiving authority shall, within 15 working days from the date indicated on
the application receipt form, request the applicant in writing to complete it
according to form No. 16 in Appendix I enclosed herewith;
5. After receiving the supplemented application,
the receiving authority shall give the application receipt form made using form
No. 01 in Appendix I enclosed herewith to the applicant; If the supplemented
application is not satisfactory, the receiving authority shall, within 15
working days from the date indicated on the application receipt form, respond
in writing and specify the reasons regarding non-issuance of import license
according to form No. 16 in Appendix I enclosed herewith; If the supplemented
application is satisfactory, the receiving authority shall issue the import
license in accordance with Clause 3 hereof;
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
submit supplemented application, the application will be rejected.
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8. The import license shall be made using Form
No. 28, 29, 30, 40, 43, and 44 in Appendix III enclosed herewith.
Section 4. IMPORT OF MEDICINAL
MATERIALS WITHOUT THE MARKETING AUTHORIZATION IN VIETNAM OTHER THAN CONTROLLED
MEDICINAL MATERIALS
Article 68. Requirements and
application for licensing import of drug substances, herbal materials,
semi-finished drugs, semi-finished herbal materials, excipients and capsule
shells for testing or research or drug concoction at healthcare and medical
facilities
1. Import of an drug substance, 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 manufacturer or
a facility which is issued with investment registration certificate for drug
manufacture but has not been issued with a certificate of eligibility for
pharmacy business or a facility specialized in testing or researching drugs or
medicinal materials;
b) it is used for manufacturing and concocting to
serve the treatment needs at healthcare and medical facilities.
2. The application for import consists of:
a) 03 original copies of the purchase order
according to Form No. 36 or 41 in Appendix III enclosed herewith;
b) A copy of the document about the quality
standards and testing method for medicinal materials of the manufacturer which
bears the importer’s seal in the case of import of medicinal materials
prescribed in point b, Clause 1 hereof;
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d) An application form made using Form No. 42 in
Appendix III enclosed herewith in the case of import of medicinal materials
prescribed in point b, Clause 1 hereof
dd) If any of the documents mentioned in points b
and c 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.
Article 69. Import of drug
substances, semi-finished drug, herbal materials and semi-finished herbal
materials for exhibition
1. Medicinal materials shall only be imported for
displaying at 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. 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 70. Applications for
licensing import of drug substances, herbal materials, semi-finished drugs and
semi-finished herbal materials for manufacture of drugs for export
1. 03 original copies of the purchase order
according to Form No. 36 or 41 in Appendix III enclosed herewith;
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Article 71. Requirements and
application for licensing import of drug substances, semi-finished drug, herbal
materials and semi-finished herbal materials to produce drugs serving national
defense and security, prevention and treatment of group-A infectious diseases
that have been declared as epidemics in accordance with laws on prevention and
control of infectious diseases, and disaster relief
1. The import of a medicinal material shall only be
licensed if it is imported to manufacture:
a) drugs serving national defense;
b) drugs serving security;
c) drugs serving prevention and treatment of
group-A infectious diseases that have been declared as epidemics in accordance
with laws on prevention and control of infectious diseases or disaster relief.
2. The application for import consists of:
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 manufacture of
drugs serving national defense and security, a written request of the Ministry of
National Defense or the Ministry of Public Security is required. The document
must contain following information: drug name, the manufacturer’s name, active
ingredients and concentration/content, dosage form, package contents, route of
administration and indications;
c) If the material is imported for manufacture of
drugs serving prevention and treatment of group-A infectious diseases that have
been declared as epidemics in accordance with laws on prevention and disaster
relief, a written approval for the list of drugs issued by the Ministry of
Health is required. The document must contain following information: drug name,
the manufacturer’s name, active ingredients and concentration/content, dosage
form, package contents, route of administration and indications;
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dd) A certified true copy of the
manufacturing license of the manufacturer or the Certificate of GMP issued by
the overseas competent authority. 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.
e) If any of the documents mentioned in points d
and dd 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.
Article 72. Applications for
licensing import of herbal materials in the cases other than those specified in
Articles 68, 69, 70, and 71 hereof
1. The application for import 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 supplier or a foreign supplier
recognized by the Ministry of Health.
If the National Technical Regulation on the herbal
material is not available in Vietnam’s supplier or a foreign supplier
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;
c) Certified true copy of the marketing
authorization of the representative office in Vietnam of the foreign exporter
which is licensed to trade in herbal materials, prepared and processed herbal
materials;
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dd) Certified and consularly legalized copies of
the certificate of GMP of manufacturers issued by competent authorities of home
countries. If the home country’s competent authority does not issue the
certificate of GMP, the applicant shall submit a certified copy of the
manufacture license or documents of equivalent legitimacy as certificate
of GMP covering manufacture of herbal materials and/or semi-finished
herbal materials;
e) A copy bearing the importer’s seal, a letter of
authorization from the manufacturer of herbal materials to the overseas
supplier, unless the manufacturer is also the supplier. The content of the
letter of authorization is specified in point dd Clause 1 Article 78 hereof.
2. Only 01 set of documents specified in this
Article is required.
Article 73. Procedures and
deadlines for licensing import of medicinal materials without the marketing authorization
in Vietnam other than controlled medicinal materials
1. Procedures and deadlines for licensing import of
medicinal materials shall comply with Articles 68, 70, and 72 hereof;
a) The applicant shall submit an application
directly or by post or online to the Ministry of Health or the People's
Committee of the province where the head office is located in accordance with
procedures specified in Article 123 hereof.
b) After receiving the application, the receiving
authority shall give the application receipt form made using form No. 01 in
Appendix I enclosed herewith to the applicant;
c) If the application is satisfactory, the
receiving authority shall issue the import license within 15 working days from
the date indicated on the application receipt form;
d) If the application is not satisfactory, the
receiving authority shall, within 15 working days from the date indicated on
the application receipt form, request the applicant in writing to complete it
according to form No. 16 in Appendix I enclosed herewith;
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e) 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
submit supplemented application, the application will be rejected.
2. In the cases of import of medicinal materials
specified in Article 71 hereof:
a) The applicant shall submit an application
directly or by post or online to the Ministry of Health;
b) After receiving the application, the Ministry of
Health shall give the application receipt form made using form No. 01 in
Appendix I enclosed herewith to the applicant;
c) If the application is satisfactory, the Ministry
of Health shall issue the export license within 03 working days from the date
indicated on the application receipt form;
d) If the application is not satisfactory, the
receiving authority shall, within 03 working days from the date indicated on
the application receipt form, request the applicant in writing to complete it
according to form No. 01 in Appendix I enclosed herewith;
dd) After receiving the supplemented application,
the Ministry of Health shall give the application receipt form made using form
No. 01 in Appendix I enclosed herewith to the applicant; If the supplemented
application is still unsatisfactory, the Ministry of Health shall notify the
applicant in accordance with point d hereof. 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 import license shall be made using Form
No. 43 or 44 in Appendix III enclosed herewith.
Section 5. EXPORT AND IMPORT
OF DRUGS AND MEDICINAL MATERIALS
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1. The period of validity of the license to export
drugs:
a) is up to 01 year for licenses to export
drugs/medicinal materials in accordance with Article 43, Article 45, Article
46, Clause 1 Article 47, and Article 48 hereof;
b) is up to 02 years for licenses to export
drugs/medicinal materials in accordance with Article 44 and Clause 5 Article 82
hereof;
2. The period of validity of the license to import
drugs/medicinal materials:
a) is up to 01 year for licenses to import drugs;
b) is up to 01 year and expires after the import is
completed for licenses to import narcotic drugs, psychotropic drugs, precursor
drugs, medicinal materials that are narcotic drug substances, psychotropic drug
substances or drug precursors;
c) is up to 02 years for licenses to import
medicinal materials other than those specified in point b hereof.
3. The period of validity of the license must
be specified therein.
Article 75. Remaining shelf
life of imported drugs/medicinal materials when customs clearance is granted
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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 other than those specified in point c hereof;
c) 1/3 of the official shelf life if it does not
exceed 9 months other than those specified in point d hereof;
d) Drugs with a shelf life shorter than 30 days
have remaining shelf life at the time of customs clearance.
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 53, Clause 1 Article 54, Articles 58, 59, 60, 68, 69, 70, and 71
hereof; imported drugs specified in Clause 5a Article 60 of the Law on
Pharmacy; imported medicinal materials specified in Article 66 hereof that
serve the testing, research, and manufacture of export drugs must be unexpired
when customs clearance is granted.
4. The People's Committee of the province where the
importer’s head office is located shall consider licensing the drug import if
the drug/medicinal material whose remaining shelf life is shorter than those
specified in point a, b, and c Clause 1 or Clause 2 hereof is essential for
manufacture, prevention and treatment of diseases, and fall under one of the
following cases:
a) There are no drugs containing the same active
ingredient and route of administration with valid marketing authorizations in
Vietnam;
b) There is a written request and commitment from
the healthcare and medical facilities about the necessity of using such drug
for prevention and treatment purposes and failure to supply drugs with the same
active ingredient and route of administration with valid marketing
authorizations.
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5. An application for import of a
drug/medicinal material mentioned in Clause 4 of this Article consists of:
a) An application form prepared by the importer,
including: name of the drug/medicinal material; batch number, quantity,
remaining shelf life at the time of customs clearance, the explanation as to
why the drug/medicinal material has a remaining shelf life at the time of
customs clearance shorter than specified in points a, b, c of Clause 1 or Clause
2 of this Article and the necessity for production, prevention, and treatment
of diseases;
b) The written request and commitment from the
healthcare and medical facilities about the necessity of using such drug for
prevention and treatment purposes specified in Clause 4 hereof and 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 points a,
b, c Clause 1 or Clause 2 hereof.
c) Only 01 set of documents specified in this
Clause is required.
6. Procedures for licensing the import of a
drug/medicinal material mentioned in Clause 4 hereof:
a) The applicant shall submit an application
directly or by post or online to the People's Committee of the province where
the head office is located;
b) After receiving the application, the People's
Committee of the province shall give the application receipt form made using
form No. 01 in Appendix I enclosed herewith to the applicant;
c) If the application is satisfactory, the People's
Committee of the province shall, within 15 working days from the day on which
the application is received, issue the written permission to import made using
Form No. 51 in Appendix III enclosed herewith;
d) If the application is not satisfactory, the
People's Committee of the province shall, within 15 working days from the date
indicated on the application receipt form, request the applicant in writing to
complete it according to form No. 16 in Appendix I enclosed herewith;
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e) Within 03 months from the day on which
additional documents are requested in writing by the People's Committee of the
province, the applicant shall submit additional documents as requested. If the
applicant fails to submit supplemented application, the application will be
rejected.
Article 76. Quantity of
drugs/medicinal materials licensed for import
1. The quantity of drugs and medicinal materials
imported according to Articles 51, 55, 56, and 66 hereof shall be approved on
the basis of the business needs of the applicant.
2. The quantity of drugs imported according to
Articles 52 and 54 hereof shall be approved on the basis of the business needs
of the healthcare and medical facility.
3. The quantity of drugs imported according to
Article 53 hereof shall be approved on the basis of the needs for national
defense and security, disease prevention, and disaster relief.
4. The quantity of drugs imported according to
Article 56 hereof shall be approved on the basis of the possibility of
achieving the price maintenance target.
5. The quantity of drugs imported according to
Article 57 hereof shall be approved on the basis of the recipient’s need.
6. The quantity of drugs imported according to
Article 58 hereof shall be approved on the basis of the description of protocol
or approved protocol of the clinical trial, bioequivalence study or the need
for drug use in testing or scientific research of the applicant.
7. The quantity of drugs imported according to
Article 60 hereof shall be approved on the basis of the treatment needs of
organizations or individuals.
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Article 77. Certificate of
analysis of the batch of imported drugs/medicinal materials
1. The certificate of analysis shall be written in
Vietnamese or English language. If the certificate of analysis is written in a
language other than Vietnamese or English language, a notarized Vietnamese or
English translation shall be included.
2. If a batch is manufactured by more than one
manufacturer, it is required to have the certificate of analysis of the final
manufacturing or packaging or releasing facility;
3. The certificate of analysis shall contain:
a) name and address of the manufacturer,
certificate of analysis number, name and signature of the responsible for
person, date of issue of the certificate of analysis;
The use of electronic signatures on the Certificate
of analysis must comply with laws on electronic transactions.
In case a certificate of analysis does not bear the
signature of the responsible person, the certificate of analysis bearing the
manufacturer's seal shall be accepted. The applicant shall assume the full
legal responsibility for the accuracy and legitimacy of the submitted
certificate of analysis;
b) Information on the sample of the drug or
medicinal material: product name; batch number; expiration date of the drug,
expiration date or retest date of the medicinal material; quality standards;
quality criteria; quality requirements; test results; conclusion on the quality
of the batch of the product.
Article 78. Suppliers of
drugs/medicinal materials
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a) A manufacturer of imported drugs/medicinal
materials;
b) The owner of the product or holder of the
marketing authorization of the imported drug or drug substance, as indicated on
the Certificate of Pharmaceutical Product, whether the drug has been granted
marketing authorization in accordance with the Law on Pharmacy or has not been
granted marketing authorization in Vietnam;
c) The applicant for registration of the drug or
medicinal materials whose marketing authorization does not expire at the time
customs and other than those mentioned in Points a and b of this Clause;
d) The establishment published by the Ministry of
Health at the request of the competent authority of the establishment’s home
country.
dd) In cases where the supplier does not fall under
points a and b hereof, they must be authorized in writing by a facility
mentioned in points a and b to supply drugs to Vietnam.
The authorization document may be an authorization
letter, sales 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) Suppliers of imported drugs specified in
Articles 53, 58, and 59 of this Decree are not required to fall under cases
specified in points a, b, c, or d hereof;
g) Suppliers of imported drugs specified in
Articles 54 and 56 of this Decree are not required to fall under cases
specified in point dd hereof.
2. Regulations of Clause 1 of this Article do not
apply to suppliers of excipients, capsule shells, primary packages of drugs;
controlled medicinal materials used for producing controlled drugs which are
imported for testing, research or production of exported drugs according to
Article 66 hereof; medicinal materials used for producing imported drugs
according to Articles 68, 69, 70, and 71 hereof; drugs as emergency aid or
humanitarian aid.
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1. The overseas competent authority where the
supplier is located may send a written request to the Ministry of Health to
declare the suppliers of imported drugs and/or medicinal materials to Vietnam.
The application must meet the following requirements:
a) It must contain the name, address, and contact
information of the competent authority of the supplier’s home country;
information about the country or territory registered to supply drugs and/or
medicinal materials to Vietnam; name of the supplier, business location,
business scope, and contact information of the supplier of drugs, medicinal
materials to Vietnam; <0}
b) It is the original copy written in English or
Vietnamese. If it is written in a language other than Vietnamese or English
language, a notarized Vietnamese or English translation shall be included.
2. The overseas competent authority where the
supplier is located as specified in Clause 1 hereof shall notify in writing to
the Ministry of Health of Vietnam:
a) If the supplier of drugs and/or medicinal
materials, which has been declared by the Ministry of Health, changes
information regarding the name, business location, or business scope: The
notification must be made within 1 month from the date of approval of the
change by the competent authority of the supplier’s home country;
b) If the supplier of drugs and/or medicinal
materials receives a decision on suspension or termination of drug business
operation from the overseas competent authority where the supplier is located:
The notification must be made within 15 days from the date on which such
decision is issued.
3. If the Ministry of Health receives a written
request from the competent authority of the supplier’s home country to declare
the suppliers of imported drugs and/or medicinal materials to Vietnam, the
Ministry of Health shall:
a) publish information specified in point a Clause
1 hereof on its website within 30 days from the date of receiving the written
request from the competent authority of the supplier’s home country;
b) comply with point a hereof in case of receiving
a written request to amend or supplement the information of the supplier of
imported drugs and/or medicinal materials, which has been declared, from the
competent authority of the supplier’s home country.
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1. A drug import license shall be revoked if:
a) The imported drug is recalled due to a
first-degree violation specified in point a Clause 2 Article 63 of the Law on
Pharmacy;
b) The marketing authorization of the drug is
revoked by the competent authority of the manufacturing country, the 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 drug substance 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.
h) The imported drug does not comply with the regulations
on drug supply stipulated in Clause 1 Article 63 hereof is.
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a) The medicinal material is recalled according
to points a, b, d, dd, or e Clause 2 Article 62 of the Law on Pharmacy;
b) The imported drug substance or herbal material
is not recommended by WHO, a competent authority of Vietnam or the country of
origin of the drug substance or herbal material.
Article 81. Reports on the
export and import of drugs, medicinal materials other than controlled drugs
1. Within 10 days from the date of importing
vaccines with the marketing authorization in Vietnam, the importer shall send a
report for each imported batch to the Ministry of Health and the National
Institute for Control of Vaccines and Biologicals using Form No. 46 in Appendix
III attached hereto.
2. Within 10 days from the date of importing
vaccines without the marketing authorization in Vietnam, the importer shall
send a report for each imported batch to the Ministry of Health, the licensing
authority according to the prescribed procedures in Article 124 hereof, and the
National Institute for Control of Vaccines and Biologicals using Form No. 47 in
Appendix III attached hereto.
3. By the 15th of January, each
exporter and importer of drugs and/or medicinal materials shall prepare an
annual report according to Form No. 49 in Appendix III attached hereto and
send it to the Ministry of Health.
Article 82. Other
regulations on export and import of drugs and/or medicinal materials
1. A medicinal material which is a drug substance,
excipient, capsule shell, semi-finished drug, or semi-finished herbal material
that has not been issued with a marketing authorization and is used for
manufacturing the drug that has been issued with a marketing authorization in
Vietnam shall be declared on website of issuing authority using Form No. 45 in
Appendix III attached to this Decree within 15 days from the date on which the
marketing authorization is issued or renewed in Vietnam. Medicinal materials on
the List of medicinal materials permitted to import shall not require applying
for an import license, other than controlled medicinal materials.
2. Medicinal materials that have the marketing
authorization in Vietnam, including herbal materials, semi-finished herbal
materials, excipients, capsule shells, and semi-finished drug other than
semi-finished controlled drugs may be imported without license.
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4. Traders may import primary packages of drugs
without an import license issued by the Ministry of Health.
5. If an exporter wishes to apply for an export
license for drugs and medicinal materials that are allowed to be exported
without a License stipulated in Clause 5 Article 60 of the Law on Pharmacy:
a) The application must include the original copy
of the Export Order Form made using Form No. 14 in Appendix III attached hereto
and a certified true copy or a copy bearing the exporter’s seal of the
Certificate of eligibility for pharmaceutical business;
b) The export licensing procedures shall comply
with Clause 1 Article 49 hereof;
6. Drugs and medicinal materials must be imported
through border checkpoints, except for drugs imported for non-commercial
purposes specified in Article 60 hereof and cases of in-country exports and
imports.
7. Imported medicinal materials according to Law on
Pharmacy and this Decree are not subject to chemical declaration procedures.
8. The import of herbal materials on the List of
controlled precious, rare species for testing or pharmaceutical research shall
comply with regulations of law on biodiversity,.
9. Institutions providing medical or pharmaceutical
training, drug testing laboratories and drug research institutions may import
drugs, medicinal materials to serve their operation.
10. Representative offices in Vietnam of
manufacturers, holders of the marketing authorization of drugs for clinical
trials, bioavailability study or bioequivalence study; providers of clinical
trial, bioavailability study or bioequivalence study services may import drugs
, medicinal materials, and primary packages of drugs for provision of clinical
trial, bioavailability study, or bioequivalence study services or testing
or research.
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a) Import drugs specified in Article 53 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.
12. A healthcare and medical facility that has a
Drug and Treatment Council and meets the requirements specified in Article 35
of the Law on Pharmacy may import drugs to meet the special treatment needs of
patients at the facility . The criteria and application for drug import
licenses shall comply with Article 54 hereof.
13. The list of drugs and medicinal materials
banned from import and manufacture is specified in Appendix V hereof.
14. An importer of drugs/medicinal materials must
not submit the application for the license to import drugs in the following
cases, except for import license applications specified in Articles 53, 54, and
55 of this Decree, if:
a) Any of the violations mentioned in points a, c,
d, and h Clause 1 Article 80 hereof;
b) Within 12 months, 02 or more batches of the
imported drug are recalled because of second-degree violations specified in point
b Clause 2 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 drug import
license is not based on research findings or the manufacturer’s capacity;
15. The entire batch of drug or medicinal material
shall be suspended from import if its manufacturer:
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b) within 12 months, produces 02 or more batches
that are recalled because of first-degree violations related to the quality of
drugs and medicinal materials specified in point a Clause 2 Article 63 of the
Law on Pharmacy;
c) Within 12 months, produces 03 or more batches
that are recalled because of second-degree violations specified in point b
Clause 2 Article 63 of the Law on Pharmacy or produces 04 or more batches that
fail to meet quality standards;
16. Durations of suspension from accepting
applications for drug import licenses, or suspension from issuing import
licenses for drugs, medicinal materials to importers stipulated in Articles 14
and 15 of this Decree are as follows:
a) 01 – 02 years for the cases mentioned in
Clause 14 and points a and b Clause 15 hereof from the date on which the
competent authority issues the document on imposition of management
measures;
b) 06 – 12 months for the cases
mentioned in point c Clause 15 hereof from the date on which the competent
authority issues the document on imposition of management measures;
17. The sale of drugs without the marketing
authorization of the importer which is a foreign-invested pharmaceutical
business shall comply with Article 53a of the Law on Pharmacy and this Decree.
Article 83. 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:
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b) The original copy or a certified true copy or a
copy bearing the exporter’s seal 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) The original copy or a certified true copy or a
copy bearing the applicant’s signature (if the applicant is an individual) or a
copy bearing the exporter’s seal (if the applicant is an organization) of
the prescription, outpatient's medical record in the cases of Clause 2 Article
46 hereof.
2. Regarding import of drugs and medicinal
materials having marketing authorization in Vietnam, medicinal materials on the
list of drug substances, excipients, capsule shells, semi-finished products,
semi-finished medicinal materials used for drug production having marketing
authorization in Vietnam, except for herbal materials:
a) The original copy or a certified true copy or a
copy bearing the importer’s seal of the Certificate of eligibility for pharmacy
business if the importer is a pharmacy business establishment;
b) The original copy or a certified true copy or a
copy bearing the importer’s seal of the import license in case of import of
controlled drugs;
c) The original copy of a copy bearing the
importer’s seal of the Certificate of Analysis of each batch of imported drug
or medicinal material;
d) A copy bearing the importer’s seal of the
authorization letter or the sales license or the certificate of partnership
according to point dd Clause 1 Article 78 hereof, except for import of
excipients, capsule shells, drugs as emergency aid or humanitarian aid;
dd) In case of import of a drug or medicinal
material specified in point dd Clause 1 Article 59 of the Law on Pharmacy and
such case does not require the import license, the importer shall provide the
shipping documents proving 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) In case of import of a drug or medicinal
material specified in point dd Clause 1 Article 59 of the Law on Pharmacy and
such case requires the import license, the importer shall provide the shipping
documents proving 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.
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h) In case of import of medicinal materials
specified in the list of drug substances, excipients, semi-finished drugs used
for production of drugs that are granted the marketing authorization in Vietnam
and such case requires the import license, the importer shall provide the
shipping documents proving that the shipment is sent from the exporting
country's port before the expiration date of the marketing authorization and
the import license which is used to declare the expired materials (if the
marketing authorization or the import license used to declare the materials is
expired at the time of customs clearance);
i) Documents proving that the drug import
notification stipulated in Clause 1 of Article 87 hereof has been sent to the
People's Committee of the province where the international checkpoint for drug
importation is located. These documents are exempted when the Vietnam National
Single-Window Portal integrated with the customs procedures processing system
for exported and imported goods, vehicles for entry, exit, and transit.
3. 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) The original copy or a certified true copy or a
copy bearing the importer’s seal of the Certificate of eligibility for pharmacy
business for verification if the importer is a pharmacy business establishment;
b) Regarding herbal materials and semi-finished
herbal materials having the marketing authorization in Vietnam, a original copy
or a certified true copy or a copy bearing the importer’s seal of the marketing
authorization;
c) Regarding herbal materials and semi-finished
herbal materials without the marketing authorization in Vietnam, a original
copy or a certified true copy or a copy bearing the importer’s seal of the license
to import herbal materials;
d) A copy bearing the importer’s seal, a letter of
authorization from the manufacturer of herbal materials to the overseas
supplier, unless the manufacturer is also the supplier. The content of the
letter of authorization is specified in point dd Clause 1 Article 78 hereof.
dd) The original copy or a copy bearing the
manufacturer’s seal of the Certificate of Analysis of each batch of the
imported herbal material or semi-finished herbal materials;
e) In case of import of a medicinal material or a
semi-finished medicinal material specified in point dd Clause 1 Article 59
of the Law on Pharmacy and such case does not require the import license, the
importer shall provide the shipping documents proving that the shipment is sent
from the exporting country's port before the expiration date of the marketing
authorization.
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h) In case of import of a medicinal material or a
semi-finished medicinal material specified in point dd Clause 1 Article 59
of the Law on Pharmacy and such case requires the import license, the importer
shall provide the shipping documents proving that the shipment is sent from the
exporting country's port before the expiration date of the marketing
authorization to be granted customs clearance.
i) In case of import of a medicinal material or a
semi-finished medicinal material with 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 shipping documents proving
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. Regarding import of drugs or medicinal
materials without marketing authorization in Vietnam, other than cases
specified in Clause 2 and Clause 3 hereof:
a) The original copy or a certified true copy or a
copy bearing the importer’s seal of the Certificate of eligibility for pharmacy
business if the importer is a pharmacy business establishment;
b) The original copy or a certified true copy or a
copy bearing the importer’s seal of the import license; other than controlled
drugs and medicinal materials without marketing authorization in Vietnam used
for clinical trials or drugs without marketing authorization in Vietnam used
for state medical programs which are not drugs as emergency aid or humanitarian
aid;
c) The original copy or a copy bearing the
importer’s seal of the Certificate of Analysis of each batch of imported drug
or medicinal material in cases of drug and medicinal material imports as
specified in Article 51, Article 52, Clause 2 Article 54, Article 55, points c
and d Clause 1 Article 57, Article 65, Article 66, point b Clause 1 Article 68,
Article 70, and Article 71 hereof;
d) A certified true copy or a copy bearing the
applicant’s signature (if the applicant is an individual) or a copy bearing the
exporter’s seal (if the applicant is an organization) of the prescription,
outpatient's medical record in the cases of Clause 2 Article 60 hereof.
dd) A copy bearing the importer’s signature of the
authorization letter or sales license or certificate of partnership stipulated
in point dd Clause 1 Article 78 hereof, other than cases of drug import
stipulated in Articles 53, 54, 56, 57, 58, and 59 hereof, primary packages of
drugs, controlled medicinal materials that are imported to manufacture drugs
for export stipulated in Article 66 hereof, medicinal materials permitted to
import stipulated in Article 68, 69, 70, and 71 hereof, controlled medicinal
materials for testing, research;
e) In case of import of a drug or a medicinal
material with 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 shipping documents proving that the shipment is sent from the
exporting country's port before the expiration date of the import license to be
granted customs clearance.
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Section 6. REPURPOSING OF
MEDICINAL MATERIALS FOR DRUG MANUFACTURE; DRUG TRANSFERS TO MEET URGENT NEEDS
FOR NATIONAL DEFENSE AND SECURITY, EPIDEMIC CONTROL, DISASTER RELIEF AND
SPECIAL TREATMENT
Article 84. Applications,
procedures, and time limits for repurposing drug substances, herbal materials
for drug manufacture that have been granted marketing authorizations and
indications for prevention and treatment of Group A infectious diseases as
announced in accordance with laws on prevention and control of infectious
diseases for imported drug substances, herbal materials for other purposes
1. The application for repurposing medicinal
materials, herbal materials includes:
Notification from the manufacturer regarding the
repurposing of drug substances, herbal materials made using Form No. 52 in
Appendix III attached hereto.
2. Procedures and time limits for repurposing drug
substances, herbal materials:
a) The manufacturer shall submit the Notification
in person or by post or online to the Ministry of Health;
b) After receiving the application, the Ministry of
Health shall give the application receipt form made using form No. 01 in
Appendix I enclosed herewith to the applicant;
c) Within 5 working days from the date of receiving
the application, the Ministry of Health shall review and notify the facility in
writing. If the information about the proposed drug substances, herbal
materials is in line with the information about the drug substances, herbal
materials for production according to marketing authorization in Vietnam, the
application shall be approved. If the application is disapproved, the Ministry
of Health shall provide the explanation.
Article 85. Transfers of
imported drugs without a marketing authorization in Vietnam to meet urgent
needs for national defense and security, epidemic control, disaster relief and
special treatment
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a) A healthcare and medical facility that has
imported or purchased drugs, vaccines to serve its special treatment needs may
transfer these drugs to another healthcare and medical facility that has a Drug
and Treatment Council or another vaccination center nationwide to serve its
special treatment needs;
b) A trader that has imported or purchased drugs,
vaccines to serve special treatment needs of a healthcare and medical facility
may transfer these drugs to another healthcare and medical facility that has a
Drug and Treatment Council or another vaccination center nationwide to serve
its special treatment needs;
c) The healthcare and medical facility or
vaccination center that receive a drug transfer must prepare and provide
documents specified in points c, d, and dd Clause 3 Article 54 hereof to the
importer or the prior recipient before receiving the drug transfer.
2. Regarding import of drugs to meet urgent needs
of national defense and security, epidemic control or disaster relief:
a) A drug that does not have a marketing
authorization in Vietnam and has been imported to meet urgent needs for
national defense and security, epidemic control, disaster relief may be
transferred to serve the needs of disease prevention and treatment;
b) The drug transfer of drugs as stipulated in this
Clause shall comply with laws on management and use of public property and
other relevant laws.
c) The facility using the transferred drugs is
responsible for the safety, effectiveness, and quality of the drugs after
receiving the drug transfer, ensuring that the drugs are used in accordance
with the approved indications.
Section 7. DRUGS SUBJECT TO
IMPORT CONTROL
Article 86. Drugs subject to
import control
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1. It is imported to meet the needs for prevention
and treatment of group A infectious diseases that have been declared as
epidemics in accordance with laws on prevention and control of infectious
diseases.
2. Drugs with a shelf life shorter than 30 days.
Article 87. Import
notification
1. The importer shall send a written notification
to the People's Committee of the province where the import is conducted at
least 05 working days before the customs clearance procedures. The written
notification includes:
a) Drug name, active ingredients, content, dosage
form, package content;
b) Name, address of the manufacturer;
c) Marketing authorization number;
d) Date of manufacture, expiration date;
dd) Batch number;
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g) Import checkpoint, expected date of import;
After the notification, the importer shall receive
a receipt number. The importer shall is responsible for the accuracy and
veracity of the notification.
In cases of changes in the information provided,
the importer shall submit a new notification in accordance with this Clause.
The new notification must indicate: “This notification replaces the
notification with receipt number…” (the receipt number of the previous
notification).
2. The People's Committee of the province shall,
within 05 working days from the date of receiving the notification from the
importer, review the following information of the imported drug according to
the notification with receipt number and compare it with the information of the
drug that has been granted a marketing authorization published on the website
of the Ministry of Health:
a) Information about the imported drug specified in
points a, b, c, and d Clause 1 hereof in the notification must correspond to
the information of the drug that has been granted a marketing authorization in
Vietnam;
b) The drug must have a valid marketing
authorization in Vietnam or use the marketing authorization according to point
c Clause 8 Article 56 of the Law on Pharmacy at the time of sending the
notification;
c) A regulatory body recommends that the drug
should be suspended from importing to Vietnam;
3. In the case where the drug fails to meet one of
the criteria specified in Clause 2 hereof at the time of sending the
notification, within 05 working days from the date of receiving the
notification, the People's Committee of the province shall notify in writing to
the customs authority at the import checkpoint and the importer to review,
adjust, and re-submit a satisfactory notification in accordance with the
regulations.
4. Within 05 working days from the date on which
the importer submits the notification, if the People's Committee of the
province does not issue a notification in accordance with Clause 3 hereof, the
importer shall carry out the customs clearance procedures.
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5. Customs authorities will conduct the
verification of customs documents in accordance with Article 32 of the Law on
Customs and other relevant customs laws.
6. An imported drug batch shall not be granted
customs clearance in the following cases:
a) The People's Committee of province issues a
notification stipulated in Clause 3 hereof, except for the case where the drug
batch is allowed to trade in accordance with point dd Clause 1 Article 59
hereof;
b) The notification period of 5 working days has not
been completed at the time of carrying out the customs clearance procedures for
the drug batch.
c) Other cases as stipulated by law.
7. Procedures specified in Clauses 1, 2, 3, and 4
hereof shall be carried out online on the Vietnam National Single-Window Portal
following the roadmap specified in Clause 2 Article 125 hereof.
Article 88. Quality testing of
drugs before being marketed
1. Drugs subject to the import control stipulated
in Article 86 hereof and failing under cases specified in Clause 3 of Article
103 of the Law on Pharmacy must undergo quality testing and meet the
requirements before being marketed.
2. The quality testing of drugs before being
marketed shall be carried out in accordance with Clauses 3, 4, and 5 of Article
103 of the Law on Pharmacy.
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4. In cases where the testing result fails to meet
the requirements, the importer shall send the result to the People's Committee
of the province where the head office is located within 3 working days from the
date of receiving the testing results from the testing facility.
5. Imported drug batches that have substandard
quality testing results shall be handled in accordance with regulations of the
Minister of Health and relevant laws.
Chapter V
MARKETING AUTHORIZATION
OF HERBAL MATERIALS, EXCIPIENTS, CAPSULE SHELLS, REGULATIONS ON THE NUMBER OF
MARKETING AUTHORIZATIONS, AND ASSESSMENT OF OVERSEAS DRUG MANUFACTURERS
Section 1. MARKETING
AUTHORIZATION OF HERBAL MATERIALS, EXCIPIENTS, CAPSULE SHELLS, REGULATIONS ON
THE NUMBER OF MARKETING AUTHORIZATIONS
Article 89. Herbal materials,
excipients, and capsule shells to be granted marketing authorizations and
conditions for marketing authorization
1. Herbal materials falling under one of the
following cases must be granted marketing authorizations before it is marketed
in Vietnam:
a) it is used as a medicinal material in Vietnam
for the first time;
b) Semi-finished herbal materials, except for cases
where these semi-finished herbal materials are manufactured by the
same manufacturer in order to produce finished drugs, semi-finished herbal
materials for producing drugs that have been granted marketing authorization in
Vietnam, semi-finished herbal materials used for testing and research, or drugs
for export.
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3. 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, it
must be granted a marketing authorization in accordance with Section
1 Chapter V hereof before being marketed in Vietnam, except for cases where the
excipient is used for manufacturing drugs that have been granted valid
marketing authorizations in Vietnam, testing, research, or manufacturing of drugs
for export.
4. A capsule shell must be granted a
marketing authorization in accordance with Section 1 Chapter V hereof before
being marketed in Vietnam, except for cases where the capsule shell is
used for manufacturing drugs that have been granted valid marketing
authorizations in Vietnam, testing, research, or manufacturing of drugs for
export.
5. The following entities may apply for marketing
authorization of herbal materials, excipients or capsule shell shells:
a) The establishments specified in Clause 3 Article
54 of the Law on Pharmacy;
b) The establishments specified in point c Clause 1
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 are specified in Articles 55 and 57 of the Law on Pharmacy.
Article 90. Authority,
documents, procedures, and time limits for issuance, renewal, adjustment, and
revocation of the marketing authorization of herbal materials, excipients and
capsule shells
The power, documents, procedures, and time limits
for issuance, renewal, adjustment, and revocation of the marketing
authorization of herbal materials, excipients and capsule shells are specified
in Article 56 and Article 58 of the Law on Pharmacy, except for cases where the
facilities that cultivate or harvest herbal materials without a Certificate of
Eligibility for pharmaceutical business, they must submit a certified true copy
of the enterprise registration certificate when submitting the application for
issuance of marketing authorization for herbal materials.
Article 91. The number of
marketing authorizations for reference biologicals
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1. Drugs for export only and not for trading in
Vietnam.
2. Drugs manufactured adopting transferred
technology.
3. Processed drugs.
4. Over-the-counter drugs;
a) For children in the form of liquid solution;
syrup; powder/granules for suspension; taste-masked powder/granules for
suspension;
b) Taste-masked lozenges.
Section 2. INSPECTIONS OF THE
COMPLIANCE WITH GMP REQUIREMENTS OF OVERSEAS MANUFACTURERS OF DRUGS AND/OR
MEDICINAL MATERIALS WHEN THEY APPLY FOR MARKETING AUTHORIZATIONS IN VIETNAM
Article 92. Cases of
inspection of GMP compliance of overseas manufacturers of drugs and/or
medicinal materials
1. Overseas manufacturers of drugs/medicinal
materials, even in cases where they are only participate in one or several
stages of production, shall undergo the assessment of the compliance with GMP
requirements when they apply for marketing authorizations for drugs/medicinal
materials in Vietnam, except for the following cases:
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b) Cases specified in point c Clause 9 Article 56
of the Law on Pharmacy.
2. Overseas manufacturers of drugs/medicinal
materials that have undergone inspection by the Ministry of Health to comply
with GMP requirements specified in Clause 5 Article 54 of the Law on Pharmacy
shall undergo an inspection of GMP compliance if:
a) The validity period of the certification of GMP
compliance for manufacturing lines has expired;
b) There are changes in the scope of certification
of GMP compliance published by the Ministry of Health;
c) There are changes in other information in the
certification of GMP compliance published by the Ministry of Health, except for
cases specified in point b hereof.
Article 93. Inspection of GMP
compliance by the method of assessment of the documents relating to
manufacturing conditions
1. The inspection method of assessment of the
documents relating to manufacturing conditions shall not be applied in the following
cases:
a) Manufacturers subject to the inspection of GMP
compliance by the method of mutual recognition and acknowledgement of
results of inspection and audit by competent authorities specified in Clause 1
Article 94 hereof;
b) Manufacturers subject to a on-site inspection
specified in points a, b, and c Clause 1 Article 95 hereof.
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a) Form No. 01 in Appendix VIII enclosed herewith;
b) GMP Certificate or manufacturing license issued
by the competent authority of the home country;
c) Report on the latest inspection of GMP
compliance by the competent authority of the home country;
d) Site master file of the manufacturer according
to the guidelines of the European Union (EU) or the Pharmaceutical Inspection
Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) or WHO;
dd) List of inspections of GMP compliance conducted
by the competent authority of the home country and competent authorities of
other countries (if any) within a period of 3 years from the date of
application submission;
e) The GMP Certificate and inspection report of GMP
compliance issued by a Stringent Regulatory Authority (SRA) or a competent
authority recognized by the Ministry of Health based on the classification of
the World Health Organization (if any)
3. Inspection procedures:
a) The applicant shall submit an application
directly or by post or online to the Ministry of Health;
b) After receiving the application, the Ministry of
Health shall give the application receipt form made using form No. 02 in
Appendix VIII enclosed herewith to the applicant;
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In cases where additional documents specified in
point e hereof are included, the inspection must be conducted within 20 days
from the date of receipt.
If the application is unsatisfactory or the
applicant fails to meet the GMP compliance, the explanation must be provided;
d) Within 10 days from the date of receipt of the
supplemented application, the Ministry of Health shall evaluate such
application and provide a written response on the GMP compliance of the
manufacturer.
If the application is unsatisfactory or the
applicant fails to meet the GMP compliance, the explanation must be provided;
dd) Within 10 days from the date of receipt of the
second supplemented application, the Ministry of Health shall evaluate such
application and provide a written response on the GMP compliance of the
manufacturer. If the supplemented application still fails to meet the
requirements, the receiving authority shall provide a written response
regarding the GMP non-compliance with an explanation;
e) Within 6 months from the date of receiving the
written response from the Ministry of Health regarding GMP non-compliance, the
applicant must submit the supplemented application as requested. If the
applicant fails to submit supplemented application, the application will be
rejected.
g) Within 3 working days from the date of providing
the inspection results on GMP compliance, the Ministry of Health shall publish
the information of the manufacturer and GMP compliance on its website.
4. Inspection content:
a) The adequacy of the application according
to Clause 2 of this Article and Article 97 hereof;
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c) The arrangement of manufacturing lines,
auxiliary systems, the level of hygiene of manufacturing rooms, equipment and
testing in the manufacturer’s site master file, except in cases where the scope
of certification stated in the documents specified in point e Clause 2 hereof
is appropriate to the inspection scope.
d) Level of GMP compliance of the manufacturer, any
deficiencies in manufacturing, testing, and storage of drugs, medicinal
materials detected in the GMP compliance report.
Article 94. Inspection of GMP
compliance by the method of mutual recognition and acknowledgement of results
of inspection and audit by drug regulatory authorities regarding the
requirements for GMP compliance for drugs, medicinal materials
1. The inspection of GMP compliance by the method
of mutual recognition and acknowledgement of results of inspection and audit by
drug regulatory authorities regarding the requirements for GMP compliance for
drugs, medicinal materials shall be applied in the following cases:
a) The manufacturer of a country included by the
Ministry of Health in the list of countries which have sign a mutual
recognition agreement on GMP inspections with Vietnam, except for cases
specified in points a and b Clause 1 Article 95 hereof;
b) A manufacturer of country whose drug regulatory
authorities are stringent regulatory authorities (SRA) or recognized by the
Ministry of Health of Vietnam based on the classification of the WHO and the
inspection of GMP compliance for such manufacturer is conducted by these
agencies, except for cases specified in points a and b Clause 1 Article 95
hereof.
2. The application includes:
a) Form No. 01 in Appendix VIII enclosed herewith;
b) GMP Certificate or manufacturing license or
report on inspection of GMP compliance in the case where the drug regulatory
authority of the home country has not issued the GMP Certificate or
manufacturing license.
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a) The applicant shall submit an application
directly or by post or online to the Ministry of Health;
b) After receiving the application, the Ministry of
Health shall give the application receipt form made using form No. 02 in
Appendix VIII enclosed herewith to the applicant;
c) The Ministry of Health shall conduct the
inspection and provide a written response on the GMP compliance of the
manufacturer within 20 days from the date of receipt. If the application is
unsatisfactory or the applicant fails to meet the GMP compliance, the
explanation must be provided;
d) Within 15 days from the date of receipt of the
supplemented application, the Ministry of Health shall evaluate such
application and provide a written response on the GMP compliance of the
manufacturer. If the application is unsatisfactory or the applicant fails to
meet the GMP compliance, the explanation must be provided;
dd) Within 15 days from the date of receipt of the
second supplemented application, the Ministry of Health shall evaluate such
application and provide a written response on the GMP compliance of the
manufacturer. If the supplemented application still fails to meet the requirements,
the receiving authority shall provide a written response on failure to meet the
GMP compliance with an explanation;
e) Within 6 months from the date of receiving the
written response from the Ministry of Health regarding GMP non-compliance, the
applicant must submit the supplemented application as requested. If the
applicant fails to submit supplemented application, the application will be
rejected.
g) Within 3 working days from the date of providing
the inspection results on GMP compliance, the Ministry of Health shall publish
the information of the manufacturer and GMP compliance on its website.
4. Inspection content and scope:
a) The adequacy of the application according
to Clause 2 of this Article and Article 97 hereof;
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c) The recognition and acknowledgement of results
of inspection and audit regarding the requirements for GMP compliance,
including the scope of certification, GMP principles and standards, and other
relevant contents.
Article 95. Inspection of GMP
compliance by the method of on-site inspection
1. The inspection of GMP compliance by the method
of on-site inspection shall be applied in the following cases:
a) It is suspected that the application for
marketing authorization provided by the manufacturer are altered; or the
information and data provided are inaccurate;
b) Drugs manufactured by the manufacturer are
concluded to violate at the first-degree by the Ministry of Health ;
c) The Ministry of Health concludes that there is
insufficient evidence to prove that the manufacturer meets the GMP
requirements;
d) GMP principles and standards of the exporting
country do not align with GMP principles and standards issued and recognized by
the Minister of Health of Vietnam;
dd) Manufacturers applying for the first-time
marketing authorization in Vietnam, except for manufacturers specified in
Clause 1 Article 94 hereof or manufacturers that have been inspected and
certified to comply with GMP by a stringent regulatory authority (SRA) or a
drug regulatory authority recognized by the Ministry of Health based on the
classification of the WHO.
2. The application includes:
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b) Documents specified in points b, c, and d Clause
2 Article 93 hereof.
3. Inspection procedures:
a) The applicant shall submit an application
directly or by post or online to the Ministry of Health;
b) After receiving the application, the Ministry of
Health shall give the application receipt form made using form No. 02 in
Appendix VIII enclosed herewith to the applicant;
c) Within 90 days from the date of receiving a
satisfactory application for cases specified in points b, d, and dd hereof, or
from the date of notification of the results of the marketing authorization
application or GMP compliance application for cases specified in points a and c
Clause 1 hereof, the Ministry of Health shall conduct the inspection and issue
a written response regarding the GMP compliance of the applicant. If the
applicant fails to meet the GMP compliance, the explanation must be provided;
d) Within 40 days from the date of receipt of the
supplemented application, the Ministry of Health shall evaluate such
application and provide a written response on the GMP compliance of the
applicant. If the application is unsatisfactory or the applicant fails to meet
the GMP compliance, the explanation must be provided;
dd) Within 40 days from the date of receipt of the
second supplemented application, the Ministry of Health shall evaluate such
application and provide a written response on the GMP compliance of the
applicant. If the supplemented application still fails to meet the
requirements, the receiving authority shall provide a written response on
failure to meet the GMP compliance with an explanation;
e) Within 6 months from the date of receiving the
written response from the Ministry of Health regarding GMP non-compliance, the
applicant must submit the supplemented application as requested. If the
applicant fails to submit supplemented application, the application will be
rejected.
g) Within 3 working days from the date of providing
the inspection results on GMP compliance, the Ministry of Health shall publish
the information of the manufacturer and GMP compliance on its website.
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a) The adequacy of the application according
to Clause 2 of this Article and Article 97 hereof;
b) The current status of the applicant, including
layout diagram of the workshop, manufacturing lines, construction materials,
manufacturing environment conditions, layout of movement paths of employee and
material, semi-finished and finished product, auxiliary systems; the level of
hygiene of manufacturing rooms; manufacturing and testing equipment, storage of
drugs and medicinal materials;
c) The manufacturing process of the manufacturing
lines for registered drugs and medicinal materials;
d) The establishment and operation of the quality
management system of the manufacturer;
dd) The current status of the GMP application and
compliance in the manufacturing, testing, and storage operations of drugs and
medicinal materials of the manufacturer.
5. The on-site inspection may be conducted remotely
through electronic means in cases where movement and travel are restricted due
to epidemics, war, or disasters.
Article 96. Inspection of
maintenance of GMP compliance
1. The applicant falling under cases specified in
points a and b Clause 2 Article 92 hereof shall submit an application for
inspection of maintenance of GMP compliance as follows:
a) Form No. 01 in Appendix VIII enclosed herewith;
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c) The GMP certificate or manufacturing license or
report of the most recent inspection of GMP compliance if the applicant has
undergone the inspection specified in Article 94 hereof
d) The GMP certificate or manufacturing license or
report of the most recent inspection of GMP compliance if the applicant has
undergone the inspection specified in Article 95 hereof;
dd) The site master file updated in case of change
of layout diagram of the workshop and manufacturing lines that have been
inspected the GMP compliance in accordance with regulations of the Ministry of
Health;
e) Other documents concerning the changed
information (if any).
2. The applicant falling under cases specified in
point c Clause 2 Article 92 hereof shall submit an application for inspection
of maintenance of GMP compliance as follows:
a) Form No. 01 in Appendix VIII enclosed herewith;
b) Other documents concerning the changed
information, including legal documents verified by competent authorities.
3. Inspection procedures:
a) The applicant shall submit an application
directly or by post or online to the Ministry of Health;
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c) The Ministry of Health shall assess the
application and provide a written response on the GMP compliance of the manufacturer
within 20 days from the date of receipt. If the application is unsatisfactory
or the fails to meet the GMP compliance, the explanation must be provided;
d) Within 15 days from the date of receipt of the
supplemented application, the Ministry of Health shall evaluate such
application and provide a written response on the GMP compliance of the
applicant. If the application is unsatisfactory or the fails to meet the GMP
compliance, the explanation must be provided;
dd) Within 15 days from the date of receipt of the
second supplemented application, the Ministry of Health shall evaluate such
application and provide a written response on the GMP compliance of the
applicant. If the supplemented application still fails to meet the
requirements, the receiving authority shall provide a written response
regarding the GMP non-compliance with an explanation;
e) Within 6 months from the date of receiving the
written response from the Ministry of Health regarding GMP non-compliance, the
applicant must submit the supplemented application as requested. If the
applicant fails to submit supplemented application, the application will be
rejected.
g) Within 3 working days from the date of providing
the inspection results on GMP compliance, the Ministry of Health shall publish
the information of the manufacturer and GMP compliance on its website.
4. Inspection content:
a) The adequacy of the application according
to Clauses 1 and 2 of this Article and Article 97 hereof;
b) The scope of certification stated on the GMP
certificate or inspection report or manufacturing license;
c) Level of GMP compliance of the manufacturer, any
deficiencies in manufacturing, testing, and storage of drugs, medicinal
materials detected in the GMP compliance report.
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5. An overseas manufacturer shall be considered
maintaining the GMP compliance in one of the following cases:
a) It has submitted an application for inspection
of GMP compliance as prescribed in Clauses 1 and 2 hereof;
b) It has provided the result of searching for GMP
compliance on websites or English-language databases of competent authorities
that conduct inspections of GMP compliance or reference links of inspection
results on maintenance of GMP compliance on websites or English-language
databases of competent authorities of the home country or regional competent
authorities that operate and determine the maintenance of GMP compliance of
manufacturers. The search must be conducted after the expiration date of GMP
compliance which has been published on the Ministry of Health’s website. The
results must bear the seal of the applicant or manufacturer, enclosed with a
document providing reference links;
c) The applicant or manufacturer is responsible for
the legitimacy and accuracy of the documents provided and the results obtained
from reference links. The authority or organization shall conduct the search
and verification according to the links provided by the applicant or
manufacturer.
Article 97. Applications of
the inspection of maintenance of GMP compliance
1. Documents as the basis for the inspection:
a) Principles and conditions for GMP compliance issued
or approved to apply by the Minister of Health;
b) Regulation on registration and management of
quality of drugs and medicinal materials;
c) If GMP principles and standards do not fall under
those that have issued or recognized for application by the Minister of Health
as stipulated in point a Clause 1 hereof, the Advisory Council for the issuance
of marketing authorization for drugs and/or medicinal materials shall conduct
the conformity assessment of principles and standards of the exporting country
with those issued or recognized by the Minister of Health. After receiving the
conformity assessment result, the Minister of Health shall issue a decision on
conformity recognition of GMP principles and standards of the exporting country
as the basis for conducting the inspection for manufacturers.
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3. Requirement for GMP certificate or manufacturing
license:
a) It must be valid at the time of application
submission;
b) If the period of validity is not specified,
these documents must be issued within a period not exceeding 3 years from the
date of application submission;
c) If it fails to meet the requirements specified
in points a and b hereof; the applicant or manufacturer must provide a written
explanation and documents proving the GMP compliance.
4. Requirements for GMP inspection report:
a) It must be issued within a period not exceeding
3 years from the date of application submission;
b) If it fails to meet the requirements specified
in point a hereof; the manufacturer must provide a written explanation and
documents proving the GMP compliance.
5. If the overseas competent authority does not
issue the GMP certificate, manufacturing license, or GMP inspection report, the
applicant or manufacturer may submit other legal documents issued by overseas
competent authorities to prove the GMP compliance.
In case of inspection of GMP compliance by the
method of mutual recognition and acknowledgement stipulated in Article 94
hereof, it may be replaced by a Certificate of Pharmaceutical Product and
information about the status of drug manufacturing registration or
information about the most recent GMP inspection conducted by the competent
authority of the home country.
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7. Documents specified in clauses 3, 4, and 5
hereof must be consularly legalized, except for the following cases:
a) The document is provided directly in writing or
via email to the Ministry of Health from the issuing country's competent
authority
b) The document is published on the website or
English-language database of the competent authority of the issuing country or
the competent authority of the operating region.
The applicant or manufacturer shall submit the
result of searching for the legal document from the website which bears its
seal and be responsible for the legitimacy and accuracy of the documents
provided and the results obtained from reference links.
8. The technical procedures for inspection of GMP
compliance or maintenance of GMP compliance of the applicant shall comply with
the regulations of the Minister of Health.
Article 98. Responsibilities
of applicants for marketing authorization of drugs/medicinal materials of
foreign manufacturers in inspection of GMP compliance; cases in which
applications for marketing authorization of drugs/medicinal materials are
rejected
1. During the inspection of GMP compliance,
the applicant shall:
a) Submit or cooperate with the manufacturer to
submit the application for the inspection of GMP compliance or maintenance of
GMP compliance as prescribed;
b) Take responsibility for the adequacy and
accuracy of documents in the application for the inspection of GMP compliance;
provide supporting documents requested by the Ministry of Health;
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d) Submit a report to the Ministry of
Health on the maintenance of GMP compliance of the manufacturer. In the
cases where the manufacturing license is revoked or the manufacturer fails
to fulfill GMP requirements according to the notification from the
competent authority in its home country, or from the issuing authority as a
Stringent Regulatory Authority (SRA) or a drug regulatory authority recognized
by the Ministry of Health based on the classification of WHO and the inspection
is conducted according to Clause 3 Article 95 hereof, the applicant shall send
a report within 15 days from the date of notification by the competent
authority.
dd) Pay the cost of inspections as prescribed by
law.
2. The application for issuance or renewal of the
marketing authorization for drugs and/or medicinal materials shall be rejected
if the applicant or the manufacturer commits any of the following violations:
a) 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 and are recalled 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) The applicant fails to send a report to the
Ministry of Health within 15 days from the date 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,
or notification of GMP non-compliance issued by a Stringent Regulatory
Authority (SRA) or a drug regulatory authority recognized by the Ministry of
Health based on the WHO classification stipulated in point d, Clause 1 of this
Article, except in cases where the applicant requests revocation of the license
for commercial reasons;
e) Shelf life of drug is falsified, except for the
case specified in Clause 3 Article 61 of the Law on Pharmacy;
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h) The applicant forges or falsifies legal
documents of Vietnamese or foreign authorities, uses a fraudulent seal or
signature of an organization in the application.
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 point d
Clause 1 Article 58 of the Law on Pharmacy and point h Clause 2 hereof;
b) 01 – 02 years in the cases specified in points a
and dd Clause 1 Article 58 of the Law on Pharmacy and points b, c, d, dd, and e
Clause 2 hereof;
c) 06 months – 01 year in the cases specified
in point b Clause 1 Article 58 of the Law on Pharmacy and point g Clause 2
hereof;
4. Applications submitted by applicants that commit
any of the violations specified in point d and h Clause 2 hereof before
the handling of violations shall 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
AUTHORITY, METHODS,
PROCEDURES FOR RECALL OF MEDICINAL MATERIALS; HANDLING OF
RECALLED MEDICINAL MATERIALS
Article 99. Types and scale of
recall
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a) Mandatory recall: under a decision of a
competent authority;
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 or by the applicant for
registration, the manufacturer or the importer (in case of voluntary recall).
Article 100. Authority to
recall and procedures for recalling medicinal materials
1. Authority to issue the decision on recall:
a) The Ministry of Health shall decide the recall
of medicinal material and issue a decision on recall in case of mandatory
recall;
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2. Procedures for recalling medicinal materials:
a) Within 48 hours from the time a recall is
decided, the Ministry of Health or the establishment mentioned in point b
Clause 1 hereof shall issue the decision on recall and inform the Ministry of
Health of the recall. Decisions on mandatory recall shall be sent to the
domestic manufacturers, importers, People's Committees of provinces, and
published 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 shall inform buyers of the materials of the recall and
organize receipt of the materials returned;
c) The recall of medicinal materials shall 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 101. 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;
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c) Take charge and cooperate with relevant entities
in publishing information about the recalled material, organize the recall and
receipt of recalled material;
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 and recall results
to the Ministry of Health.
2. Each distributor of the recalled material shall:
a) Stop buying and selling the recalled material;
b) Inform and receive the recalled material from
manufacturers;
c) Return the material to its supplier.
dd) Pay for the recall and handling of recalled
material (even if the recall is enforced) and pay damages if the distributor is
at fault.
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a) Stop using the material;
b) Return the material to its supplier.
4. The Ministry of Health shall:
a) Conclude 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 recall results
of manufacturers;
c) Direct the People's Committee of province to
inspect and supervise the organization and implementation of the recall of
medicinal materials and take actions against violators under the management;
d) Decide enforcement of recall if the
domestic manufacturer or importer fails to carry out the recall as requested;
dd) Publish information about the recalled
medicinal materials on its website if they have to be destroyed.
5. The People's Committee of 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 102. Handling of
recalled materials
1. Recalled medicinal materials that are
herbal materials or drug substances 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 drug substance 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 manufacture
drugs that are not recommended by WHO.
2. Recalled 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 drug substances, 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.
Recalled medicinal materials that are not recycled
or re-exported shall be destroyed.
Manufacturers and importers shall be responsible
for reporting to the Ministry of Health on the implementation of recycling,
re-exporting, or destroying the revoked medicinal materials.
4. Recycled medicinal materials shall be
marketed or used only when they meet the following conditions:
a) The recycling activities are carried out at a
facility that meets GMP compliance;
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c) The recycling medicinal materials has undergone
a quality inspection by an authority specialized in testing drugs and medicinal
materials according to quality standards approved by the Ministry of Health .
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 members, one of which has to be the
establishment’s chief pharmacist.
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 36 of this Decree.
Chapter VII
CONTENTS OF DRUG
ADVERTISEMENTS, APPLICATIONS, PROCEDURES, APPRAISAL, AND CERTIFICATION OF DRUG
ADVERTISEMENTS; RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS IN
IMPLEMENTING, PARTICIPATING IN DRUG ADVERTISING
Article 103. Contents of drug
advertisements
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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.
d) In cases where the information about the drug in
documents specified in points a, b, c hereof is not consistent, the drug
advertisement content must be based on the label and package insert approved by
the Ministry of Health.
2. The drug advertisement contents have the
following compulsory information:
a) Name of drug;
b) Drug substances or herbal materials in the
approved package insert. Names of herbal materials must be written in
Vietnamese language. Names of untranslatable foreign herbal materials may be
written in Latin language;
c) Indications;
d) Uses;
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e) Contraindications and warnings for special users
(pregnant women, breast-feeding women, children, old people, people having
chronic diseases) (if any);
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...(cơ quan xác nhận): .../XNQC..., ngày ... tháng ... năm...;”
(“Number and date of the certification of drug advertisement contents issued by
the… (the name of the certification authority): …”) at the end of the first
page;
m) Pages of a multi-page document must be numbered.
The first page must specify the number of pages and contain the list of
content;
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.
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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.
7. The font size in drug advertisement content must
be clear, easy to read. Minimum font size: 12; Font: VnTime or Times New Roman;
Page: A4.
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.
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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, using this drug is the best solution, the drug can be
used without physician’s counsel, the drug is completely harmless, 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 or exaggerates 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” and those with similar
meanings.
7. The following indications:
a) Treatment of tuberculosis or leprosy;
b) Treatment of sexually transmitted diseases;
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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
9. Pre-clinical study results.
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.
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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 105. Issuance,
adjustment, and correction of the certificates of drug advertisement contents
1. A certificate 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 drug advertisement content has been issued a
certificate but has changes that do not fall under Clause 2 hereof.
2. A certificate of drug advertisement contents
shall be adjusted in case the drug advertisement content changes in:
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b) Information about the name or address of the
applicant without replacing the applicant;
c) The applicant;
d) Information about the package content; the
symbol of the applicant or manufacturer without slogan;
dd) Logo of the applicant or the manufacturer with
slogan which are a protected trademark according to the Trademark Registration
Certificate issued by the competent authority.
3. Modify the certificate of drug advertisement
contents in case the information recorded on such certificate is incorrect due
to an error by the issuing authority.
Article 106. First-time
application for the certificate of drug advertisement contents
1. The application for the certificate of drug
advertisement contents, except for drug advertisements in the form of a
conference, convention or event, includes: <0}
a) Form No. 01 in Appendix VI enclosed herewith;
b) Design of the proposed drug advertisement content
to be certified; recording of the advertising content on audio-visual media,
print media, electronic devices, advertising screens, and other advertising
media according to regulations on advertisements with sound and moving images;
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d) Reference documents relevant to the drug
advertisement contents to be certified (if any);
dd) License for establishing a representative
office of a foreign enterprise in Vietnam (if the applicant is a foreign
establishment) or Certificate of eligibility for pharmaceutical business (if
the applicant is a Vietnamese pharmacy business establishment). The Certificate
of eligibility for pharmaceutical business issued by the Ministry of Health is
not required if the applicant is a Vietnamese pharmacy business establishment;
e) Authorization letter from the applicant for drug
registration to the applicant for certificate of drug advertisement contents
(If any).
2. The application for the certificate of drug
advertisement in the form of a conference, convention or event consists of:
a) Form No. 02 in Appendix VI enclosed herewith;
b) The drug advertisement contents;
c) Specimens of the label and package insert
approved by the Ministry of Health;
d) Reference documents relevant to the drug
advertisement contents to be certified (if any);
dd) License for establishing a representative
office of a foreign enterprise in Vietnam (if the applicant is a foreign
establishment) or Certificate of eligibility for pharmaceutical business (if
the applicant is a Vietnamese pharmacy business establishment). The Certificate
of eligibility for pharmaceutical business issued by the Ministry of Health is
not required if the applicant is a Vietnamese pharmacy business establishment
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g) Program of the drug advertisement conference,
convention or event.
3. Only 01 set of documents specified in Clauses 1
and 2 of this Article is required.
Article 107. Requirements for
the application for the certificate of drug advertisement contents
1. Documents mentioned in point c Clause 1, point c
Clause 2 Article 106 hereof shall be copies.
2. Documents mentioned in points d and dd
Clause 1, points d and dd Clause 2 of Article 106 hereof must be copies which
bear the applicant’s seal (if they are issued by the Ministry of Health) or
certified true copies or copies accompanied by the original for verification
(if they are not issued by the Ministry of Health).
3. Documents mentioned in point e Clause 1 and
point e Clause 2 of Article 106 hereof must be original copies or certified
true copies or copies accompanied by the original for verification.
4. Documents specified in point b Clause 1, point b
Clause 2 of Article 106 hereof must be original copies and made into 2 copies.
5. Each application for issuance of the certificate
of drug advertisement contents shall contain:
a) 01 specimen of the design or audio-visual
recording of drug advertisement content for the application specified in Clause
1 Article 106 hereof or 01 drug advertisement content for the application
specified in Clause 2 Article 106 hereof for 01 drug;
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6. Documents shall be printed on A4 paper sheets.
For large outdoor advertisements, drug advertisement content may be presented
on A3 paper sheets, on which the scale of the dimensions compared to the actual
size is indicated. Documents must bear fan stamping of the applicant for the
certificate of drug information. In case the design has a spatial structure,
the application must include a description on A3 paper sheets with the
following mandatory contents:
a) Spatial structure;
b) Numbering of surfaces, dimensions of each
surface;
c) Size ratio of the design template compared to
the actual model.
7. The following entities may apply for the
certificate of drug advertisement contents:
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 point a Clause 1 hereof;
8. Applicants for drug registration, including
those authorizing the entities mentioned in points b and c of Clause 7 hereof
to apply for the certificate of drug advertisement contents shall take
responsibility for the information provided.
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1. The applicant shall submit the application for
the certificate of drug advertisement contents in person or by post or online
to the Ministry of Health.
2. Within 15 days from the date on which the
satisfactory application is received, the Ministry of Health shall conduct the
appraisal according to advertising laws and issue the Certificate to the
applicant using Form No. 03 or Form No. 04 in Appendix VI attached hereto. If
the application is rejected, the Ministry of Health shall respond and provide
explanation in writing.
3. If the application is not satisfactory, within
15 days from the date on which the application is received, the Ministry of
Health shall request the applicant in writing to complete the application. To
be specific:
a) The written request shall specify necessary
adjustments and/or additions;
b) Within 15 days from the date on which the
amended application is received, the Ministry of Health shall conduct the
appraisal according to this Decree and advertising laws then issue the
Certificate to the applicant using Form No. 03 or Form No. 04 in Appendix VI
attached hereto, or reject the application and provide explanation;
c) Within 90 days from the day on which additional
documents are requested in writing by the Ministry of Health, the applicant
shall submit additional documents as requested. Otherwise, the application will
be rejected.
4. While the application is being processed,, the
Ministry of Health shall suspend granting the certification 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 authorities 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 methods mentioned in Clause 3 Article 105 hereof, the
holder of the certificate of drug advertisement contents shall send a
notification of the time and location and a copy of the certificate of drug
advertisement contents to the People's Committee of the province where the drug
advertisement is provided.
If the time or location is changed, the People's
Committee of the province must be informed at least 01 (one) working day before
conducting the drug advertising.
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a) Legal documents issued by regulatory authorities
in the application for certification of drug information are falsified or
forged;
b) 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;
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 certificate of drug advertisement for:
a) 01 – 02 years in the cases specified in point a
Clause 6 hereof;
b) 06 – 12 months in the cases specified in points
b, c, and dd Clause 6 hereof;
8. Within 03 working days from the date on which
the certificate of drug advertisement contents is issued, the Ministry of
Health shall publish the Certificate on its website.
Article 109. Procedures for
correction and adjustment of the certificate of drug advertisement contents
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2. In the case where the information on the
certificate of drug advertisement contents that has been issued is incorrect as
stipulated in Clause 2 Article 105 hereof, the applicant shall send a written
notification to the issuing authority and specify incorrect information to be
corrected. The facility shall make the adjustment and be responsible for and be
responsible for the adjusted drug advertising content.
Article 110. Effect the
certificate of drug advertisement contents
1. The certificate of drug advertisement contents
does not have a specific expiration date and shall be invalidated in the
following cases:
a) The marketing authorization is invalidated;
b) The marketing authorization is revoked;
c) A change to drug information is made that
requires issuance of another certificate of drug advertisement contents
according to point b Clause 1 Article 105 hereof;
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.
2. When the marketing authorization
expires but is continued to be used in accordance with point c Clause 8
Article 56 of the Law on Pharmacy or has been renewed, the certificate of drug
advertisement contents shall be automatically renewed with the same duration as
that of the marketing authorization if it does not fall under the cases
stipulated in Clause 1 hereof.
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1. A drug advertiser shall:
a) Fulfill the obligations stipulated in the Law on
Advertising;
b) Ensure that the content of drug advertisement
complies with advertising laws;
c) Assume the full legal responsibility for the
content of drug advertisement, even in cases of delegated drug advertisement;
d) Only provide the drug advertisement content that
has been confirmed by the competent authority to advertisement distributors and
advertising service providers;
dd) Perform other responsibilities as stipulated by
law.
2. A drug advertising service provider shall:
a) Fulfill the obligations stipulated in the Law on
Advertising;
b) Provide documents related to the content of drug
advertisement at request of competent authorities;
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d) Jointly take responsibility in cases where
the drug advertisement content fails to comply with drug advertising laws;
dd) Perform other responsibilities as stipulated by
law.
3. A drug advertisement distributor shall:
a) Perform the responsibilities stipulated in
points b, c, d, and e Clause 2 hereof and obligations stipulated in the Law on
Advertising;
b) Not distribute drug advertisement content and
information on medical conditions, treatment methods, health communication that
may lead to the understanding of the cause, consequence, or result of using or
not using that drug;
c) Perform other responsibilities as stipulated by
law.
Chapter VIII
MEASURES FOR DRUG PRICE
MANAGEMENT
Section 1. ANNOUNCEMENT,
RE-ANNOUNCEMENT OF INTENDED WHOLESALE DRUG PRICES FOR PRESCRIPTION DRUGS
AND PROPOSALS FOR INTENDED WHOLESALE DRUG PRICES THAT HAVE BEEN ANNOUNCED,
RE-ANNOUNCED<0}
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1. The list of announcement of intended wholesale
drug prices for imported drugs into Vietnam and domestically manufactured drugs
is made using Form No. 01 in Appendix VII attached hereto.
2. The list of re-announcement of intended
wholesale drug prices for imported drugs into Vietnam and domestically
manufactured drugs is made using Form No. 02 in Appendix VII attached hereto.
Article 113. Entities
responsible for announcing, re-announcing intended wholesale drug prices
1. Domestic drug manufacturers shall announce or
re-announce the intended wholesale drug prices for domestically manufactured
prescription drugs.
In the case where the drug manufactured
domestically is processed in Vietnam, its manufacturer or
processing facility shall announce or re-announce its intended wholesale price.
2. Drug importers shall announce or re-announce the
intended wholesale drug prices for imported prescription drugs into Vietnam.
Article114. Procedures for
announcement, re-announcement of intended wholesale drug prices
1. Entities specified in Article 113 hereof shall
announce the intended wholesale drug prices before selling the first batch of
drugs to the Vietnamese market. Such entity shall not announce the intended
wholesale price for subsequent production batches or subsequent import shipments
if there are no price adjustments.
2. If there is a need to change the intended
wholesale price which has been announced or re-announced on the Ministry of
Health's website, entities specified in Article 113 hereof shall follow the re-
announcement procedures. <0}
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4. The Ministry of Health shall receive the List of
announcement or re-announcement of intended wholesale drug prices. In the case
where the list of announcement or re-announcement of intended wholesale drug
prices is satisfactory and the applicant has paid the fee as required, within 1
working day, the Ministry of Health shall issue a Receipt according to Form No.
03 in Appendix VII attached hereto. In the case where such List is
unsatisfactory, within 1 working day, the Ministry of Health shall return it to
the applicant and provide the explanation.
5. Within 07 days from receiving a satisfactory
application, the Ministry of Health shall review the drug information in the
announced or re-announced intended wholesale drug price list based on the
marketing authorization or drug import license and publish it on the Ministry
of Health’s website. In case the announced or re-announced intended wholesale
drug price is not published, the Ministry of Health will respond in writing and
provide the explanation.
6. The announcing/re-announcing entity shall comply
with regulations on announcing or re-announcing the intended wholesale drug
prices in Law on Pharmacy and this Decree; assume the full legal responsibility
for the accuracy and legitimacy of the information on the announced or
re-announced intended wholesale drug price list; follow the reporting
requirements for the intended wholesale drug prices at request of regulatory
bodies to serve the price maintenance, state price management, inspection, and
audit; comply with the inspection and audit of competent authorities (if any).
Article 115. Drugs to be
exempt from announcing the intended wholesale drug prices
Prescription drugs which are manufactured
domestically or imported for non-commercial purposes shall be exempt from
announcing the intended wholesale drug prices if:
1. The drugs, vaccines are used free of charge for
the people to meet the urgent needs for national defense, security, disaster
relief, and prevention of epidemics.
2. The drugs are used to serve state medical
programs.
3. The drugs are humanitarian aid drugs.
4. The drugs are used for clinical trials;
bioequivalence studies, bioavailability assessment; as samples for
registration, testing, scientific research, or display at fairs or exhibitions.
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Article 116. Protesting
announced or re-announced intended wholesale drug price in cases where the
intended wholesale drug price is higher than the highest price of a similar
drug that has been announced or re-announced without a protest from the
Ministry of Health
1. In cases where the intended wholesale drug price
that has been announced or re-announced has the same concentration with a
similar drug that has been announced or re-announced, the Ministry of Health
shall lodge a protest if:
a) It is higher than the highest announced or
re-announced intended wholesale price of a drug manufactured on a manufacturing
line that complies with the equivalent GMP requirements;
b) It is manufactured overseas under the
supervision of a stringent regulatory authority and is higher than the
announced or re-announced intended wholesale price of the brand-name drug or a
reference biological;
c) It is manufactured overseas under the
supervision of a drug regulatory authority which is not a stringent regulatory
authority and is higher than the announced or re-announced intended wholesale
price of such drug manufactured under the supervision of a stringent regulatory
authority, the brand-name drug or a reference biological;
d) It is manufactured on a manufacturing line that
complies with the GMP principles and standards of WHO and is higher than the
announced or re-announced intended wholesale price of such drug manufactured on
a manufacturing line that complies with the GMP principles and standards of EU
or equivalent.
2. In cases where the intended wholesale drug price
that has been announced or re-announced has the different concentration with a
similar drug that has been announced or re-announced, the Ministry of Health
shall lodge a protest if:
a) It is higher than the announced or re-announced
intended wholesale price of a similar drug from the same manufacturer with a
higher concentration;
b) It is higher than the announced or re-announced
intended wholesale price of a similar drug from the same manufacturer with a
larger package content.
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1. The percentage difference between the announced
or re-announced intended wholesale drug price and the successful bid price
(hereinafter referred to as “percentage difference”) is the ratio (%)
calculated by dividing the monetary value difference of the announced or
re-announced intended wholesale drug price and the highest successful bid price
within 12 months from the date on which the protest is provided by the
announced or re-announced intended wholesale drug price. The formula for
calculating the price difference is as follows:
Percentage
difference (%)
=
Announced or
re-announced intended wholesale drug price
-
Highest successful
bid price within 12 months from the date on which the protest is lodged
x
100
Announced or
re-announced intended wholesale drug price
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a) 35% for drugs with announced or re-announced
intended wholesale drug price calculated based on the smallest packaging unit
< VND 1.000.000.
b) 15% for drugs with announced or re-announced
intended wholesale drug price calculated based on the smallest packaging unit ≥
VND 1.000.000.
Article 118. Protesting
announced or re-announced intended wholesale drug price in cases where such
price is higher than the selling price in the country of origin or another
country and there is no similar drug sold in Vietnam
The Ministry of Health shall lodge a protest for
announced or re-announced intended wholesale drug price when there is no
similar drug sold in Vietnam and the announced or re-announced intended
wholesale drug price is higher than the selling price in the country of origin
or another country in the following cases:
1. The announced or re-announced intended wholesale
drug price is higher than the selling price in the country of origin or another
country according to the information provided in the List of intended wholesale
drug prices.
2. The announced or re-announced intended wholesale
drug prices is higher than the selling price in the country of origin or
another country according to the information provided by regulatory agencies of
Vietnam or foreign countries.
3. The announced or re-announced intended wholesale
drug prices is higher than the price information available on websites of drug
price management authorities, health insurance agencies, drug procurement
agencies of countries provided by the regulatory agencies of Vietnam or foreign
countries.
Article 119. Procedures for
protesting for announced or re-announced intended wholesale drug prices
1. In cases where the announced or re-announced intended
wholesale drug price is detected to fail under one of the
cases specified in Articles 116, 117, and 118 of this Decree, the Ministry of
Health shall lodge a protest for the announced or re-announced intended
wholesale drug price. Such protest shall be sent to the
announcing/re-announcing entity and published on the Ministry of Health's
website.
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3. After the announcing/re-announcing entity sends
a report and provides an explanation, the Ministry of Health shall assess the
suitability in terms of fluctuations in price formation factors, the difference
between the announced or re-announced intended wholesale drug price and the
updated winning bid price, or price information in the country of origin or
another country and decide whether removing the protest or providing a
feedback.
During the procedures, the Ministry of Health may
cooperate with relevant agencies and organizations to assess the explanation
content.
Section 2. LIMITS ON RETAIL
MARKUP UPON DRUG RETAILERS WITHIN MEDICAL EXAMINATION AND TREATMENT FACILITIES;
POLICIES ON PRICE MAINTENANCE, PRICE REDUCTION FOR NEW DRUGS, BRAND-NAME DRUGS,
HIGH-TECH DRUGS, VACCINES, AND RARE DRUGS TRANSFERRED TO VIETNAM UNDER
PRODUCTION TECHNOLOGY TRANSFER CONTRACTS
Article 120. Limits on retail
markup upon drug retailers within medical examination and treatment facilities
1. The retail markup is the value of the difference
between the selling price and the purchase price of drugs for drug retailers within
medical examination and treatment facilities, calculated according to the
following formula:
Retail markup =
Selling price of drug - Purchase price of drug
2. The retail markup rate is the
percentage (%) between the retail markup and the purchase price of drugs
for drug retailers within medical examination and treatment facilities,
calculated according to the following formula:
Retail markup rate
(%)
=
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x
100
Purchase price of
drug
3. The retail price of drugs at drug retailers within
medical examination and treatment facilities is calculated according to the
following formula:
Retail drug price =
Purchase price of drug x (1 + Retail markup rate)
4. The retail markup rate for drug retailers within
medical examination and treatment facilities shall not exceed the maximum
retail markup rate as follows:
a) 15% for drugs with a purchase price per smallest
packaging unit not exceeding VND 1.000;
b) 10% for drugs with a purchase price per smallest
packaging unit exceeding VND 1.000 – but not exceeding VND 5.000;
c) 7% for drugs with a purchase price per smallest
packaging unit exceeding VND 5.000 – but not exceeding VND 100.000;
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dd) 2,5% for drugs with a purchase price per
smallest packaging unit exceeding VND 1.000.000;
Article 121. Policies on
price maintenance, price reduction for new drugs, brand-name drugs, high-tech
drugs, vaccines, and rare drugs manufactured adopting transferred technology in
Vietnam
1. A new drug, brand-name drug, high-tech drug,
vaccine, or rare drug manufactured adopting transferred technology shall be
subject to price maintenance and price reduction policies in the price
negotiation plan for packages executed adopting price negotiation method if:
a) It is manufactured in Vietnam and has been
granted a marketing authorization through technology transfer or it is
processed adopting transferred technology;
b) It is manufactured overseas and has been granted
a Certificate of registration of technology transfer in accordance with
technology transfer laws, and has implemented manufacturing trials on
manufacturing lines adopting transferred technology to prepare the application
for marketing authorization for drugs manufactured adopting transferred
technology or drugs processed adopting technology transferred.
2. Principles of applying price maintenance and
price reduction policies:
a) A brand-name drug which has not been granted a
valid marketing authorization or has been granted ≤ 3 marketing authorizations
at the time of price negotiation plan formulation for drugs manufactured in
countries having stringent regulatory authorities and having the same active ingredient,
concentration, dosage content shall have its price stabilized based on the
successful bid result or price negotiation result of the drug provided to
examination and treatment facilities during the price negotiation plan
formulation; <0}
b) A new drug, high-tech drug, vaccine, or rare
drug which has not been granted a valid marketing authorization or has been
granted ≤ 3 marketing authorizations at the time of price negotiation plan
formulation for drugs manufactured in countries having stringent regulatory
authorities and having the same active ingredient, concentration, dosage
content shall have its price stabilized based on the successful bid result or
price negotiation result of the drug provided to examination and treatment
facilities during the price negotiation plan formulation;
c) In cases where there is no technology transfer,
drugs that are not subject to price maintenance policies in accordance with
points and b hereof be subject to a maximum discount rate of 50% compared to
the discount rate in the price negotiation plan.
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a) Drugs that meet the requirements specified in
point a Clause 1 hereof shall apply price maintenance or price reduction policy
once from the date of the issuance of the marketing authorization;
b) Drugs that meet the requirements specified in
point a Clause 1 hereof and have transferred the entire manufacturing process
to Vietnam may be entitled to an additional application of the policy in the
next price negotiation;
c) Drugs that meet the requirements specified in
point b Clause 1 hereof shall apply price maintenance or price reduction policy
once from the date of implementation of manufacturing trials on manufacturing
lines adopting transferred technology in Vietnam. The implementation of
manufacturing trials on manufacturing lines shall be proved by trial
manufacturing batch records of receiving facilities or processing facilities
adopting technology transferred.
Chapter IX
IMPLEMENTATION CLAUSES
Article 122. Deadlines for
fulfillment of Good Practice requirements for state-owned drug testing
facilities
1. From the effective date of this Decree,
state-owned drug testing facilities which have not fulfilled Good Laboratory
Practice requirements shall only conduct tests within the scope of
certification of eligibility according to TCVN ISO/IEC 17025 - General
requirements for the competence of
testing and calibration laboratories which has been inspected and certified by
certification organizations. By January 01, 2027, state-owned drug testing
facilities must comply with Good Laboratory Practice.
2. From the effective date of this Decree,
state-owned testing facilities for drugs and medicinal materials must comply
with Good Laboratory Practice when implementing drug testing activities or
expanding the scope of testing activities for the first time.
Article 123. Deadlines for
exercising the authority to grant licenses for export and import of drugs and
medicinal materials
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a) Issue import licenses for drugs, drug
substances, herbal materials, semi-finished drugs, semi-finished herbal
materials, excipients, and capsule shells stipulated in Articles 57, 58, 59,
65, 68, 70, and 72 of this Decree;
b) Issue export licenses for drugs, medicinal
materials, herbal materials on the List of controlled precious, rare and
endemic medicinal material species and varieties stipulated in Article 43;
Article 44; Article 45; points b and c Clause 1 of Article 46; Clause 1 of Article
47; Article 48; and Clause 5 of Article 82 of this Decree;
2. From July 1, 2027, the People's Committee of the
province where the head office is located shall issue export and import
licenses for drugs, drug substances, herbal materials, semi-finished drugs,
semi-finished herbal materials, excipients, and capsule shells as prescribed in
Clause 1 of this Article.
Import and export licenses issued by People's
Committees of provinces are valid nationwide.
Article 124. Time limits for
receiving reports and reporting forms for the export, import, inventory, and
use of drugs and medicinal materials
1. Before July 1, 2027, the Ministry of Health
shall receive reports from manufacturers, exporters, and importers of drugs and
medicinal materials stipulated in Clause 1 Article 35 and Clause 2 Article 81
hereof.
2. From July 1, 2027, the reporting procedures
specified in Clause 1 Article 35 and Clause 2 Article 81 hereof shall be
carried out as follows:
a) People's Committees of provinces shall receive
reports for cases of import and export of drugs and medicinal materials
stipulated in Article 43, Article 44; points and c Clause 1 Article 46; Clause
1 Article 47; and Articles 48, 57, 58, 59, 65 of this Decree;
b) The Ministry of Health shall receive reports for
cases of importing drugs and medicinal materials, except for cases specified in
point a hereof.
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1. From July 1, 2028, the activities specified in
Article 87 hereof shall be implemented.
2. The Ministry of Finance shall cooperate with the
Ministry of Health to implement the development of online tools on the Vietnam
National Single-Window Portal to ensure the implementation of Clause 1 hereof.
Article 126. Time limits for
announcement of intended wholesale drug prices for prescription drugs
Within 30 days from the effective date of this
Decree, if the prescription drug had its first wholesale batch sold but the
intended wholesale drug price has not been announced or there is a change in
the intended wholesale drug price announced, re-announced on the Ministry of
Health’s website before July 01, 2024, the entity responsible for announcing,
re-announcing the intended wholesale drug price shall comply with procedures
specified in Section 1 Chapter VIII hereof.
Article 127. Transition
clauses
1. Applications submitted according to regulations
of the Law on Pharmacy No. 105/2016/QH13 and relevant guiding documents
submitted before the effective date of this Decree shall be processed in
accordance with the Law on Pharmacy No. 105/2016/QH13 and relevant guiding
documents; except the cases where the applicant requests the implementation of
the Law No. 44/2024/QH15 amending and supplementing some provisions of the Law
on Pharmacy No. 105/2016/QH13 or this Decree.
2. Licenses for export and import of drugs and/or
medicinal materials, orders for export and import of drugs and/or medicinal
materials, and relevant administrative procedures shall be implemented in
accordance with Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP, Decree No.
88/2023/ND-CP, and relevant documents during the period of validity of the
licenses.
Drugs and medicinal materials exported or imported
under the licenses and orders stipulated in this Clause shall be granted
customs clearance if they meet the provisions of Decree No. 54/2017/ND-CP,
Decree No. 155/2018/ND-CP, Decree No. 88/2023/ND-CP, and relevant documents or
provisions of this Decree that facilitate enterprises, organizations, and
individuals.
For drugs used in clinical drug trials that are not
classified as controlled drugs, in cases where the import license for the drug
has expired or the import license is valid but the drug information has been
updated in the Ministry of Health's list of imported drugs for clinical trials,
the importer shall import the drugs based on the information published by the
Ministry of Health.
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4. Certificates of drug information, certificates
of drug advertisement contents issued before the effective date of this Decree
shall remain valid until their expiration dates.
5. From July 1, 2026, the Ministry of Public
Security shall share data on the criminal record of the applicants for
Pharmaceutical Practice Certificates with issuing authorities upon request.
Shared data includes information on the criminal records in accordance with the
Law on Criminal Record.
6. For prescription drugs that have their prices
declared or re-declared in accordance with Clause 3 Article 107 of the Law on
Pharmacy No. 105/2016/QH13, in cases where there is no change in the previously
declared or re-declared price, the importer or manufacturer is not required to
make a announcement. The price shall be used as the announced or re-announced
intended wholesale drug price.
Article 128. Amendments to
Decree No. 31/2021/ND-CP dated March 26, 2021 on elaboration some articles of
the Law on Investment
Clause 11 shall be added after Clause 10 Section IV
Part A. List of business lines eligible for investment incentives enclosed with
Decree No. 31/2021/ND-CP as follows:
“11. Research and development of technology,
production, or technology transfer for the production of herbal medicines,
traditional medicines from domestic medicinal sources, drug substances, new
drugs, brand-name drugs, rare drugs, the first domestically produced generic
drugs, high-tech drugs, vaccines, biological products; cultivation of medicinal
plants in disadvantaged areas or extremely disadvantaged areas; research for
conservation and development of valuable, rare, and endemic medicinal genetic
resources in the country; creation of new strains from economically valuable
medicinal genetic resources with a new investment project (including expanding
that new establishment project that meets the provisions in Clause 2 Article 8
of the Law on Pharmacy”.
Article 129. Effect
1. This Decree comes into force from July 01, 2025.
2. The following regulations and documents are
annulled:
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b) Decree No. 54/2017/ND-CP;
c) Chapter II and Clause 4 Article 21 of Decree No.
155/2018/ND-CP;
d) Decree No. 88/2023/ND-CP;
dd) Article 3 of Decree No.181/2013/ND-CP;
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 130. Responsibility
for organization of implementation
1. The Minister of Health shall provide guidance
and organize the implementation of this Decree.
2. Chairpersons of the People’s Committees of
provinces shall organize the reception of drug price declarations according to
the Law on Prices and its guiding documents; implement incentives for
development of drug supply system, retail drug outlets in ethnic minority
areas, mountainous regions, islands, disadvantaged areas and extremely
disadvantaged areas.
3. By July 01, 2027, the Ministry of Health shall
implement a management software system and data for exports and imports of
drugs and medicinal materials nationwide.
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5. Organizations and individuals conducting
administrative procedures online shall comply with the following regulations:
a) Documents required to be submitted as original
copies or certified copies specified in this Decree must be electronic copies
with adequate and accurate content;
b) They must comply with online administrative
procedures stipulated in Decree No. 45/2020/ND-CP.
c) They must retain the original copies or
certified copies and the application to serve post-inspection tasks and assume
the full legal responsibility for the accuracy and legitimacy of the assume the
full legal responsibility for the accuracy and legitimacy of the submitted
application.
6. Ministers, Heads of ministerial agencies, Heads
of Governmental agencies, Chairpersons of People’s Committees of provinces,
other relevant organizations and individuals shall be responsible for the
implementation of this Decree./.
ON BEHALF OF
GOVERNMENT
PP. PRIME MINISTER
DEPUTY PRIME MINISTER
Le Thanh Long
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