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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
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No.: 47/2010/TT-BYT
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Hanoi, December 29, 2010
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CIRCULAR
GUIDING THE EXPORT, IMPORT OF MEDICINES AND
PACKAGING IN DIRECT CONTACT WITH MEDICINES
Pursuant to the
Law on Pharmacy No. 34/2005/QH11 dated June 14, 2005;
Pursuant to the
Law on Prevention and Combat of Medicines No.23/2000/QH10 dated December 09,
2000 and the Law amending, supplementing a number of Articles of the Law on
Prevention and Combat of Medicines No.16/2008/QH12 dated June 03, 2008;
Pursuant to the
Decree No.188/2007/ND-CP dated December 27, 2007 of the Government stipulating
the function, tasks, powers and organizational structure of the Ministry of
Health;
Pursuant to the
Decree No.79/2006/ND- CP dated August 09, 2006 of the Government detailing the
implementation of a number of Articles of the Law on Pharmacy;
Pursuant to the
Decree No.58/2003/ND-CP dated May 29, 2003 of the Government prescribing the
control of the import, export and transit through Vietnam’s territory of
narcotics, pre-substances, addictive medicines and psychotropic medicines;
Pursuant to the
Decree No.12/2006/ND-CP dated January 23, 2006 of the Government detailing the
implementation of the Commercial Law concerning international trading
activities and activities of agents, purchase, sale, processing and transit of
goods with foreign countries;
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Ministry of
Health guides the export, import of medicines and packaging directly contacted
with medicines as follows:
Chapter I
GENERAL
PROVISIONS
Article 1. Scope of governing
1. This Circular
guides the export and import of medicines and packaging in direct contact with
medicines.
2. Exported and
imported medicines through non-trade route to heal for the importers’,
exporters’ own and their family are not subject to this Circular.
Article 2. Interpretation of terms
In this Circular,
the terms below are construed as follows:
1. Country of
origin means the country that produces final dosage forms and/or goods lots
shipped or country where the products are shipped to the importing country.
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3. Commercial
packaging of medicines means packaging containing medicines and circulated
together with medicines. Commercial packaging of medicines includes two types:
- Direct packaging
means packaging containing in direct contact with medicines;
- Outside
packaging means packaging used to package one or more medicine units having
direct packaging.
4. The radioactive
substance means substance emitting radiation due to nuclear fission, nuclear
energy transitions, having its own level of radioactivity or total level of
radioactivity of more than the exemption rate.
5. Radioactive
pharmaceutical substances mean pharmaceutical substances that contain
radioactive substances used for the diagnosis and treatment.
6. Radioactive
medicines mean medicines that contain one or more radioactive pharmaceutical
substances used for diagnosis or treatment.
7. Exemption level
from declaration, grant means the level of radioactivity that from such level or
less the radioactive substances are considered harmless to humans, environment.
Article 3. Conditions and scope of organizations and individuals
participating in export and import of medicines, packaging in direct contact
with medicines
1. For traders who
are enterprises of Vietnam:
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b) Enterprises
trading medical equipment and enterprises having certificates of eligibility
for medicine trading are imported directly and received entrusting to import
medical biological products for In Vitro diagnosis;
c) Enterprises
having certificates of eligibility for medicine trading and certificate
obtaining standards "Good Manufacturing Practice" (GMP) are imported
raw materials for medicine manufacture of such enterprises and sold to other
medicine production enterprise;
d) Production
enterprises having certificates of eligibility for medicine trading from
medicinal materials are imported to serve the needs of enterprises’
manufacturing and sold to other medicine production establishments, the
traditional examination and treatment establishments;
đ) Enterprises
having certificates of eligibility for medicine trading and valid permits to
carry out radiation work granted by the competent authority are imported
directly radioactive medicines not exempted from the declaration, grant.
2. For traders who
are enterprises with direct foreign-owned capital in Vietnam having
certificates of eligibility for medicine trading (the scope of medicine
production) are imported raw materials for medicine production of such
enterprises. The export and import of medicines not serving for medicine
production of such enterprises will be guided by the Ministry of Health in
other documents.
3. Vietnam traders
having certificates of eligibility for medicine trading are exported, entrusted
for export, received entrusting for export of medicines, except for narcotics,
psychotropic medicines, pre-substances used as medicines and radioactive
medicines.
4. Traders are
allowed to entrust for export of medicines in accordance with the scope of
activities specified in the certificates of eligibility for medicine trading,
except for narcotics, psychotropic medicines, pre-substances used as medicines
and radioactive medicines.
5. Organizations
and individuals who are not traders on the basis of contracts signed under the
provisions of law, are entrusted for export, import of medicines to serve the
needs of use of such organizations and individuals, except for narcotics,
psychotropic medicines, pre-substances used as medicines and radioactive
medicines.
6. Representative
offices of foreign traders having operating licenses on medicines and materials
for making medicines in Vietnam, Vietnam traders having certificates of
eligibility for medicine trading are allowed to import medicines to serve the
circulation registration (including medicines for testing, appraising as
required by the registration of medicines).
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8. The medical
examination and treatment establishments of the provinces, cities, branch
health and organizations of Vietnam (referred to as the Vietnam parties) are
allowed to receive medicine assisted, given from charitable organizations,
NGOs, foreign individuals, overseas-based Vietnamese (referred to as foreign
parties) and are responsible for the use of medicines effectively, safely,
reasonably, proper aid purposes.
9. Organizations
and individuals with clinical testing medicine are imported medicines for the
clinical testing according to research plan of testing medicines on such
clinique approved by the Ministry of Health.
10. Organizations
and individuals having such research plan of bioavailability, bioequivalence
approved by the specialized technical agency authorized by the Ministry of
Health are imported medicines for the study of the bioavailability,
bioequivalence.
11. Traders are
allowed to import, export packaging in direct contact with the medicine.
12. For foreign
traders supplying medicines into Vietnam:
a) Foreign traders
supplying medicines, pharmaceutical materials, medicines from pharmaceutical
materials, traditional medicines into Vietnam must be enterprises having
operating license on medicines and medicine-making materials in Vietnam;
b) Foreign traders
providing excipients and packaging in direct contact with medicines and
organizations and individuals stipulated in clauses 5, 6, 7, 8 and 9 of this Article
are not required to be enterprises having operating license on medicines and
medicine-making materials in Vietnam;
c) Where the
medicines needed for prevention and treatment demand of disease and raw
materials needed for domestic medicine production needs but the enterprises
having operating license on medicines and medicine-making materials in Vietnam
do not provide or provide not enough demand, Drug Administration Department-
Ministry of Health considers and decides to allow imports from the prestige
companies providing medicine all over the world.
Article 4. General provisions on import and export of medicines
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Traders that
manufacture, import, export, supply, entrust, receive entrusting of import and
export of medicines, packaging in direct contact with the medicines are
responsible for the quality and safety of imported medicines according to
provisions of Pharmacy Law, Commercial Law and other regulations on the
management of current medicine quality.
2. Expiry date of
imported medicines:
a) Finished
medicines imported into Vietnam with expiry date of more than 24 months, the
remaining expiry date must be at least 18 months from the date of arrival in
Vietnam. For medicine with expiry date of equal to or less than 24 months the
remaining expiry date must be at least 12 months from the date of arrival in
Vietnam;
b) Vaccines,
medical biological products without registration numbers, when imported into
Vietnam they must have a remaining expiry date of at least by 2/3 of expiry
date from the date of arrival in Vietnam;
c) Vaccines,
medical biological products with valid circulation registration numbers in
Vietnam, when imported into Vietnam, they must have a remaining expiry date of
at least by 1/2 of expiry date from the date of arrival in Vietnam;
d) Biological
products used in In Vitro diagnosis with expiry date of equal to or less than
12 months when imported into Vietnam, they must have a remaining expiry date of
at least by 03 months from the date of arrival in Vietnam;
đ) Raw materials
for making medicines imported into Vietnam, except for pharmaceutical
materials, must have remaining expiry date of more than 36 months from the date
of arrival in Vietnam, for raw materials with expiry date of equal to or less
than 36 months, the arrival date of the Vietnam's ports is not exceeded 06
months from date of manufacture;
e) Medicine of
aid, humanitarian aid with expiry date of more than or equal to 24 months, the
remaining expiry date of medicine must have a minimum period of 12 months from
the date of arrival in Vietnam. Where medicine with expiry date of less than 24
months, the remaining expiry date from the date of arrival in Vietnam is at
least equal to 1/3 of medicine’ expiry date;
g) The medicines
and medicine-making materials not meeting the regulations on expiry date of
medicines in points a, b, c, d and đ of this clause but ensuring the quality
and need to be imported to serve the needs of treatment, demand in the domestic
production of medicines, Drugs Administration Department - Ministry of Health
shall consider and decide and be responsible for grant of import permits.
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When making
customs clearance procedures, the enterprises importing medicines, packaging in
direct contact with medicines must present to the customs of border gate the
original of testing sheet of the production establishments certified obtaining
quality standards for each batch of imported medicines of manufacturers except
for pharmaceutical materials and medicines specified in Article 12, 13, 14, 15,
17 and 18 of this Circular.
Customs of border
gate shall save a copy of testing sheet stamped confirmation of the importing
enterprise.
4. Intellectual
property rights on medicines, packaging in direct contact with the medicines:
Traders that
manufacture, import, export, supply, trust, receive entrusting of import and
export of medicines, packaging in direct contact with medicines must take
responsibility for intellectual property rights of medicines, packaging in
direct contact with medicines due to the establishments produce, import,
export, supply, entrust import and export.
5. Testing,
clinical testing for vaccines and medical biological products as serum
containing antibodies imported:
a) For vaccines
and medical biological products as serum containing antibodies used to disease
prevention and treatment with or without circulation registration numbers in
Vietnam imported, after the customs clearance, they are taken to the warehouse
of enterprise for storage as prescribed and only allowed to put into use when
having written certification of the National Institute for Expertise of
Vaccines and Medical Biological Products that lots of vaccines, serum
containing antibodies used to prevent and treat disease imported obtain
standards of quality and safety on experimented animals.
b) For vaccines
and medical biological products as serum containing antibodies for disease
prevention and treatment without the import registration number used for the
programs and national projects, they are required to implement clinical trial
of medicines prepared as prescribed in Decision No.01/2007/QD-BYT on 11/01/2007
of the Minister of Health stipulating on clinical trial of medicines.
Particularly for
vaccines and medical biological products as serum containing antibodies for
disease prevention and treatment without circulation registration numbers but
they are pre-tested by the World Health Organization (WHO) and circulated
worldwidely by the international organizations which regularly cooperate with
Vietnam in the medical field such as WHO, UNICEF ... aid to Vietnam, as the
case by case basis, the Drugs Administration Department - Ministry of Health requires
proof of cold chain implementation and results of safety testing satisfactory
on human in the field, then they are allowed put to use.
c) With respect to
vaccines and medical biological products as serum containing antibodies for
disease prevention and treatment imported under the provisions of Article 13,
14, 15 and 16 of this Circular, if necessary, the Drugs Administration
Department - Ministry of Health will require safety testing on humans in the
field and after obtaining satisfactory results on safety testing on humans in
the field, they are allowed to put into use.
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For labels of
imported medicines, they must be complied with the provisions of Decree
No.89/2006/ND-CP dated 30/9/2006 of Government on the goods labels, the
provisions in Circular No.04/2008/TT-BYT dated 12/05/2008 of the Minister of
Health on guiding labeling of the medicines except for labels prescribed in
Article 12, 13, 14, 15, 16, 17 and 18 of this Circular.
7. Declaration,
redeclare the price of medicines:
The declaration
and re-declaration of the price of imported medicines is made in accordance
with provisions in Circular No.11/2007/TTLT-BYT-BTC-BCT on 31/08/2007 by the
Health Ministry.
- The Ministry of
Industry and Trade guides the implementation of state management on prices of
medicines for human use.
8. Report:
a) Within 10 days
from the date that vaccines, medical biological products as serum containing
antibodies are imported into warehouses, importing enterprises sends import
report for each lot of imported goods to the Drugs Administration Department -
Ministry of Health and the National Institute for Expertise of Vaccines and
Medical Biological Products (Form 1a).
b) Importing
enterprises must report to the Drugs Administration Department - Ministry of
Health on situation of import and export of medicines monthly in electronic
file to the mailbox qlkdd@dav.gov.vn before 10th of next month; written 06
month report before July 10 and the whole year report before January 10, of next
year. (Form 1b1 to b13).
c) Enterprises
importing medicines for shows, exhibition, fairs and other cases of temporary
import for re-export: Within 10 days after the end of shows, exhibition, fairs
activities or expiry of temporary import, enterprises must re-export and send
written report to the the Drugs Administration Department -Ministry of Health
on the number and situation of re-export (Form 1C).
9. Fees:
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10. The effective
duration of the import, export permits of medicines: Import, export permits of
medicines are valid for a period of 01 year from the date of signing.
11. Legal
documents in import dossier of medicines:
a) Certificate of
pharmaceutical product (CPP), certificate of free sale (FSC) certificate of
obtaining standards of Good Manufacturing Practice (GMP) or certificates obtaining
equivalent standards for In Vitro diagnostic biological product may be
submitted the original or copy or a Vietnamese translation from foreign
languages, but required to meet specific regulations for each type of
certificate defined in point b, point c or point d of this clause and the
general provisions as follows:
- In case of
handing in the original: the original must be had all signatures directly, full
name, title, the date of issuance and certified seal by the competent
authorities of the home country where granted the certificate; and it must be
legalized consulate in diplomatic missions of Vietnam under the law regulations
on consular legalization, unless the legal documents issued by the competent
authorities of the countries signed the Agreement on mutual legal assistance
with Vietnam;
- In case of
handing in the copy: A copy duly authenticated in accordance with the law
regulations of Vietnam on the authentication of copies from the originals by
the competent agencies of Vietnam;
- Where handing in
the Vietnamese translations from foreign languages: Vietnamese translation must
be notarized public in accordance with provisions (“notarized public” is
interpreted to be the local notary public agencies or diplomatic missions,
consular agencies or other agencies authorized from foreign countries in the
signature certification of the translator in accordance with the law
regulations) and must submit together with the original or copy of certificate
under the above provisions;
- Validity of the
certificate: the validity must be indicated specifically on the certificate and
must be valid at the time of evaluation; the written extension of the
certificate shall not be accepted. Where the certificate is not specified the
validity, then only the certificates issued within 24 months from the date of
grant are accepted.
b) For certificate
of pharmaceutical products, apart from meeting the provisions in point a of
this clause, it also must meet the following provisions:
- Must have
written certification of medicines permitted for circulation in the country of
origin, if medicines are not circulated in the country of origin, the supply
company must send the reason explanations to the Drugs Administration
Department - the Ministry of Health for consideration;
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- Where there is
no CPP of the countries of origin mentioned above, only CPPs of the medicine
which are approved by the competent authorities of one of the countries such as
UK, France, Germany, USA, Japan, Australia, Canada or the agencies of
assessment and evaluation of medical products in Europe – EMEA are accepted;
- Issued by
competent Medicines Administration agency (the list of available
http://www.who.int WHO) of the country of origin; issued under form of WHO
applied to the quality certification system of products circulated in
international trade.
c) For certificate
of free sale, in addition to meeting the provisions in point a of this clause,
it also must meet the following provisions:
- Must have
written certification of medicines permitted for circulation in the country of
origin, if medicines are not circulated in the country of origin, the supply
company must send the reason explanations to the Drugs Administration
Department - the Ministry of Health for consideration;
- Issued by the
competent authorities of the country of origin, having sufficient information
on the composition, concentration, dosage form and validity of the certificate.
d) Certificate of
obtaining standards of Good Manufacturing Practice, or the certificates of
obtaining other quality management systems (eg ISO 9001 ...) and must be issued
by the competent authority of the country of origin, confirmed the name and
address of the manufacturer.
Article 5. Regulations on the making of goods orders, languages and
forms of dossiers
1. Order of import
and export of medicines, packaging in direct contact with the medicines is made
in 03 copies in the form appropriate to each medicine prescribed in this
Circular. After being approved, 02 copies shall be kept at the Drugs Administration
Department - the Ministry of Health, 01 copy is sent to the importing,
exporting enterprises of medicines. The copy sent to the importing, exporting
enterprises of medicines is stamped "dispatch for enterprise" for
making customs procedures at border gates. Order of import and export of
narcotics, psychotropic drugs, pre-substances used as medicines, including the
types of single substances or in combination with the valid circulation
registration numbers are made into 02 copies.
2. Where
enterprises receiving entrusting of import and export of medicines, it must
specify the name of the entrusting company of importing, exporting medicines on
the order.
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4. The language
used in the medicine import dossiers:
Dossier of foreign
medicines import must be written in Vietnamese or English. If the dossier is written
in English, the information in the instruction manual of medicine must be
written in Vietnamese, except for the following contents are allowed to write
in other languages with Latin root words:
a) Name of
proprietary medicines, international nonproprietary or generic name of the
medicine;
b) International
nonproprietary names or scientific names of ingredients, ingredient quantities
of medicines in the cases of unable to translate into Vietnamese or translated
into Vietnamese but it is nonsense;
c) Name and
address of the foreign enterprises of production, manufacture franchise of
medicines.
5. For finished
medicines without import registration number under the provisions of Article 11
of this Circular, each medicine must be made in a separate order, except for
medicines that share all the following elements can be imported in same
dossier:
a) Name of
medicine;
b) Dosage form;
c) The formula for
a dose unit (for the medicine form of single dose) or the same concentration content
(for multi-dose medicine);
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Article 6. Some other provisions
1. Imported
medicines circulated on the market must meet the provisions in clause 1 of
Article 36 of the Pharmacy Law.
2. Imported
medicines for projects and programs of national health goals, medicines of aid,
humanitarian aid; medicines imported for the purpose of clinical trials, as the
registration sample, for research, testing, appraisal; medicines imported for
participation in shows, trade fairs and exhibitions must be used for right
purposes, right objects and not allowed to circulate on the market.
3. Medicine of aid
imported by organizations and individuals stipulated in clause 8, Article 3 of
this Circular, after the receipt, the receiving unit must set up a council to
inventory, evaluate and classify medicines and warehousing to manage. Only the
medicine ensures quality, and its expiry date still remains, is allowed to put
into use for treatment. For medicines not allowed to be used, it is required to
set up a council to conduct the medicine destruction in accordance with
provisions of the Circular No.09/2010/TT- BYT dated April 28, 2010 on quality
management, ensuring not to cause environmental pollution.
Heads of units
that receive aid medicines must bear full responsibility for the quality of
medicines, using medicines effectively, reasonably and safely.
4. Medicines of
aid, humanitarian aid must meet the following requirements:
a) Must be allowed
to circulate in the home country. For vaccines and medical biological products
as serum containing antibodies, they must be of the list of vaccines and
medical biological products that are recommended to use by Health Organization;
b) Must meet the
requirements of actual use of the aid recipient unit and the national medicine
policy of Vietnam;
c) Not being on
the list of addictive medicines, the list of raw materials and finished
medicines banned from import for making medicines for human use (except for
medicine import for program, national projects that were approved by the
government);
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đ) Must be packed
in suitable packaging items, stating the name of medicine, active substance,
concentration, dosage form, packing, together with instructions manual for use
of medicines and a detailed list included each packing unit.
e) In special
cases, medicine of aid for research programs do not meet the provisions of
points a, b, c, d and đ of this clause, may be considered for the receipt based
on legal documents, concerned technical of the research programs.
5. Pharmaceutical
materials used for production, preparation, and traditional medicines in the
medicine manufacturing establishments, medical examination, and treatment
establishments by traditional medicines for the disease prevention and
treatment for human must meet quality standards and provided by the sufficient
condition establishments for medicine trading.
6. For radioactive
medicines, in addition to the implementation of the provisions of this
Circular, they shall comply with the provisions of law relating to radiation
safety.
Chapter II
MANAGEMENT FORMS
OF IMPORT AND EXPORT OF MEDICINES AND PACKAGING IN CONTACT WITH MEDICINES
Article 7. Import of medicines, the packaging in direct contact with
medicines
1. Forbidden to
import to make medicines for human use the finished medicines and
medicine-making materials specified in the list of raw materials and finished
medicines banned from import for making medicines (Annex).
2. Medicines with
valid circulation registration numbers, except for narcotics, psychotropic drugs,
pre-substances used as medicine imported by demand are not required to request
for import permits or certification of imported goods order.
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a) Addictive
medicines, psychotropic drugs, pre-substances used as medicines, including
those in single or mixed substances with the valid circulation registration
numbers;
b) Finished
medicines, raw materials used for making medicines, vaccines and medical
biological products without the registration number;
c) Packaging in
direct contact with medicines.
Article 8. Export of medicines, packaging in direct contact with
medicines
1. Addictive
medicines, psychotropic drugs, pre-substances used as medicines, including
those in single or mixed substances when exporting, it is required to have
export permit of the Drugs Administration Department- Ministry of Health.
2. Medicines,
packaging in direct contact with medicines, except for those specified in
clause 1 of this Article as exporting, exporters make procedures directly with
the customs of border gate, without required to have export permit of the
Ministry of Health.
Chapter III
RECORDS AND PROCEDURES
FOR IMPORT OF MEDICINES, PACKAGING IN CONTACT WITH MEDICINES, TESTING OF
IMPORTED MEDICINES
Item I. IMPORT OF MEDICINES HAVING VALID REGISTRATION NUMBER
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1. Dossier:
a) Import order
(Form 2a, 2b);
b) Inventory
report of addictive medicines (or psychotropic medicines, pre-substances used
as medicines) (Form 3).
2. Procedures:
The enterprises
send dossiers to the Drugs Administration Department-Ministry of Health. Within
15 working days from the date of receiving valid dossiers, the Drugs
Administration Department-Ministry of Health shall issue the import permits. In
case of refusal, the Drugs Administration Department-Ministry of Health shall
send written replies, clearly stating the reasons.
Article 10. Other medicines, except for those specified in Article 9 of
this Circular
Exporting
enterprises make procedures directly at the border gate customs and present a
list of imported medicines to border-gate customs (Form 4) together with the
original or copy notarized public validly the following documents:
a) The permit for
circulating products or the decision to grant circulation registration numbers;
other documents to allows the change, supplementation or corrections (if any);
b) Operating
license on medicines and medicine-making materials in Vietnam for foreign
companies to supply medicines, unless the traders specified in point b, c,
clause 12, Article 3 of this Circular.
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Article 11. Finished medicines containing pharmaceutical substance
without registration number or such pharmaceutical substance having the
registration number but not meeting sufficient treatment needs, medical
biological products used for disease prevention, treatment, diagnosis
1. Conditions and
number of medicines considered for import permits:
Comply with the
provisions of Article 7 of Decision No.151/2007/QD-TTg dated 12/09/2007 of the Prime
Minister promulgating the Regulation on the import of medicines without
registration numbers in Vietnam.
2. Dossier:
a) Import order
(Form 5a, 5b, 5c, 5d, 5đ);
b) Certificate of
pharmaceutical products. Where having no certificate of pharmaceutical
products, it can be replaced by the FSC and GMP. Where there are many
production establishments participating in the production of medicines, the
importing establishments must hand in GMP certificate of all production
establishments participating in the production of finished products;
c) Standard and
testing methods of quality of medicines;
d) Medicine labels
and instruction manual with seal of importers, including 01 set of the original
label with the original instruction manual of the medicine being circulated in
reality in the country of origin (excluding vaccines, medical biological
products); 02 sets of labels expected for circulating in Vietnam together with
instruction manual in Vietnamese;
đ) The inventory
report for addictive medicines, psychotropic drugs and pre-substances used as
medicine (Form 3);
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3. Procedures:
The enterprises send
dossiers to the Drugs Administration Department-Ministry of Health. Within 20
working days from the date of receiving valid dossiers, the Drugs
Administration Department-Ministry of Health shall consider for issuance of the
import permits. In case of refusal, the Drugs Administration
Department-Ministry of Health shall send written replies, clearly stating the
reasons.
Article 12. Rare medicines, medicines for the treatment needs of the
hospital in special cases
1. Dossier:
a) Import order
(Form 6a);
b) Reserves for
rare medicines, medicines for the treatment needs of the hospital in special
cases (Form 6b);
c) The documents
specified at points b, c, d, đ and e, clause 2, Article 11, except for the
following cases:
- Enterprise
organizing chain of pharmacies obtaining standard "good pharmacy
practice" GPP needs to import the list of rare medicines and medicines
imported for the needs of hospital treatment in special cases to sell at the
pharmacies obtaining GPP in the system: it must have document stating clearly
the reason for not yet supplying dossiers, original testing sheet, and
commitment to take responsibility for ensuring the quality of imported
medicines;
- Enterprises
importing medicines on the list of rare medicines, medicines imported for the
needs of hospital treatment in special cases or the medicines with active
substance, concentration, contents, dosage form without registration number for
circulation in Vietnam but recorded in specialized documents but unable to
offer the records specified in clause 2 of Article 11 of this Circular and
original testing sheet of the imported medicine lots, the records must be
included: Written reason statement that are unable to provide records of
imported medicines, original testing sheet of medicines lots and commitment on
ensuring the quality of imported medicines; report of medicine use (demand for
use, safety and effectiveness of medicine treatment).
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The enterprises
send dossiers to the Drugs Administration Department-Ministry of Health. Within
15 working days from the date of receiving valid dossiers, the Drugs
Administration Department-Ministry of Health shall consider for issuance of the
import permits. In case of refusal, the Drugs Administration
Department-Ministry of Health shall send written replies, clearly stating the
reasons.
Article 13. Vaccines and medical biological products as special
treatment needs of the treatment facilities, establishments of vaccination and
testing establishments
1. Dossier:
a) Import order
(Form 7a);
b) Reserves of
vaccines, medical biological products of the establishments of vaccination,
testing establishments (Form 7b);
d) The supplier’
commitment on quality assurance of vaccines and medical biological products
provided to Vietnam (Form 7c);
đ) The attached
documents (if any) include: Certificate of production facilities obtaining GMP
standards or certificate of production facilities obtaining standard of quality
management system (ISO) issued by the competent agencies (for In vitro
diagnostic medical biological products), permits for the circulation of
vaccines and medical biological products, permits for the circulation in some
other countries where such vaccines and medical biological products are
registered circulation. In special cases, the companies have not provided
enough materials or vaccines, medical bio-products not meeting the provisions
in points b, c, and d, clause 2 of Article 4 of this Circular but they are
necessary for needs of use, the Drugs Administration Department - Ministry of Health
shall consider and decide.
2. Procedures:
The enterprises
send dossiers to the Drugs Administration Department-Ministry of Health. Within
15 working days from the date of receiving valid dossiers, the Drugs
Administration Department-Ministry of Health shall consider for issuance of the
import permits and require to send dossier, samples to the National Institute
for Expertise of Vaccines and Medical Biological Product for vaccines, medical
biological products imported in case of necessity.
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Article 14. Medicines meeting urgent needs for prevention of disease,
remedies of natural disaster
1. Dossier: import
order (Form 8);
2. Procedures:
The enterprises
send dossiers to the Drugs Administration Department-Ministry of Health. Within
05 working days from the date of receiving valid dossiers, the Drugs
Administration Department-Ministry of Health shall consider for issuance of the
import permits. In case of refusal, the Drugs Administration
Department-Ministry of Health shall send written replies, clearly stating the
reasons.
Article 15. Medicines for the programs of national health goals
1. Dossier:
a) Import order
(Form 9);
b) Documents
issued by the competent authorities on the import of medicines for the program
of national health goals (if necessary the Drugs Administration
Department-Ministry of Health may request records under the provisions of
points b, c, d and e, clause 2 of Article 11 of this Circular);
c) With respect to
vaccines and medical biological products as serum containing antibodies used
for disease prevention and treatment, apart from the papers prescribed at
points a and b, clause 1 of this Article, it shall also be required to add the
following documents:
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- Certificate of
production establishment obtaining GMP standard;
- Testing paper of
obtaining the quality standard of vaccines, medical bio-products of the
national accreditation agency or other competent authorities of the home
country for lots of imported goods (certified true copy of the importer);
- Medicine test
results on clinique or safe trial results on human in the field in accordance
with provisions in point b, clause 5 of Article 4 of this Circular.
d) For vaccines,
medical biological products imported as a result of successful bidding of
national or international bidding in Vietnam, the documents as prescribed in
sections 1, 2 and 3 point c, clause 1 of this Article considered by the program
as reviewing bidding dossier, dossier requesting for import is not required to
have the above papers.
2. Procedures:
a) Medicines of
the program of national health goals must be entrusted through the enterprises
with direct importing function of medicines. On medicine’s labels must be had
the phase "program medicine not for sale".
b) Within 15
working days from the date of receiving valid dossiers, the Drugs
Administration Department-Ministry of Health shall consider for issuance of the
import permits. In case of refusal, the Drugs Administration
Department-Ministry of Health shall send written replies, clearly stating the
reasons.
Article 16. Aid medicines, aid medicines for humanitarian
1. Dossier:
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b) List of
medicines of aid, humanitarian aid (Form 10);
c) Documents
issued by the competent authority on the permission of the establishment to
receive medicines of aid, humanitarian aid;
d) For vaccines
and medical bio-products as serum containing antibodies used for disease
prevention and treatment, in addition to the papers prescribed at points a, b
and c, clause 1 of this Article, it is required to add the papers specified in
section 1, 2 and 3 point c, clause 1, Article 15 of this Circular.
2. Procedures:
The importing
establishments send dossiers to the Health Department in the area, where
medicine contains the new pharmaceutical substance, the medicine with a new
combination of such pharmaceutical substance circulated, vaccines, and medical
biological products: The importing establishments send dossiers to the Drugs
Administration Department-Ministry of Health. Within 15 working days from the
date of receipt of order, and valid dossiers, the Health Department or the
Drugs Administration Department -Ministry of Health shall consider for issuance
of the import permits. In case of refusal, the Health Department or the Drugs
Administration Department-Ministry of Health shall send written replies,
clearly stating the reasons.
Article 17. Medicines used for clinical trials, as sample for
registration and for the research, testing, appraisal, research of
bioavailability/bioequivalence
Comply with the
provisions in clauses 1, 2, 4, Article 9 of Decision No.151/2007/QD-TTg dated
12/9/2007 of the Prime Minister stipulating on the import of medicines without
registration numbers in Vietnam.
1. Dossier:
a) Import order
(Form 11a, 11b, 11c);
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c) Research plan
of such bioavailability, bioequivalence approved by the specialized technical
agencies authorized by the Ministry of Health for imported medicines to study
the bioavailability, bioequivalence;
d) The written
approval of the competent authorities for the implementation of the research
with approval or with written requirement of the competent authorities on the
import of medicines for testing, appraisal;
đ) Where
establishments of production, research, and testing require importing medicines
to serve the research and testing made by them, they must attach to a written
request and commitment of imported medicines for using only to serve the
research and testing of them.
2. Procedures:
The importing
establishments send dossiers to the Drugs Administration Department-Ministry of
Health. Within 15 working days from the date of receipt of order, and valid
dossiers, the Drugs Administration Department-Ministry of Health shall consider
for issuance of the import permits. In case of refusal, the Drugs
Administration Department-Ministry of Health shall send written replies,
clearly stating the reasons.
Article 18. Medicines for participation in the shows, exhibitions and
fairs and other cases of temporary import for re-export of medicines
Comply with
provisions in clause 3, Article 9 of Decision No.151/2007/QD-TTg dated
12/9/2007 of the Prime Minister stipulating on the import of medicines without
registration numbers in Vietnam and the provisions of Article 12 of Decree
No.12/2006/ND-CP dated 23/01/2006 of the Government detailing the
implementation of the Commercial Law regarding international trading activities
and activities of agents, purchase, sale, processing and transit of goods with
foreign countries.
Article 19. Medicinal-making materials, pharmaceutical materials
without circulation registration numbers, packaging in direct contact with
medicines
1. Dossier:
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b) The copy of
quality standards and testing methods of materials, pharmaceutical materials,
packaging in direct contact with the medicines for the raw materials, packaging
with quality standards and testing methods of the manufacturers or copy of
quality standards treatise of pharmacopoeia if raw materials are not applied
the quality standards of the Pharmacopeia of European, the United Kingdom,
United States, International Pharmacopeia, and of Japan;
c) For
medicine-making materials as addictive medicines, psychotropic drugs,
pre-substances used as medicines, they must be enclosed the inventory report
(Form 3).
2. Procedures:
The Enterprises
send dossiers to the Drugs Administration Department-Ministry of Health. Within
07 working days from the date of receiving valid dossiers, the Drugs
Administration Department-Ministry of Health shall consider for issuance of the
import permits.
For
medicine-making materials, as addictive medicines, psychotropic drugs,
pre-substances used as medicines, within 15 working days from the date of
receiving valid dossiers, the Drugs Administration Department-Ministry of
Health shall consider for issuance of the import permits.
In case of
refusal, the Drugs Administration Department-Ministry of Health shall send
written replies, clearly stating the reasons.
Article 20. Radioactive medicines
1. For radioactive
medicines in case of exemption of declaration, license grant: To comply with
the provisions of Article 11 of this Circular.
2. For radioactive
medicines in case of not being exempted from declaration, license grant: To
comply with the provisions of Article 11 of this Circular together with the
permits of conducting radiation works granted by the competent authorities for
direct business enterprise of radioactive medicines.
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Article 21. Vaccines and medical biological products, serum containing
antibodies
1. Dossier:
a) Form submitting
samples for inspection;
b) The brief
profile of production and inspection of lots of imported vaccines, imported
medical biological products (a copy stamped and certified by the manufacturer);
c) Output permit
granted by the competent agency of home country or of an another equivalent
body together with each batch of imported goods lot (a copy stamped and
certified by the Director of importer);
d) Proof of
security on the cold chain in the transport of imported goods lot.
e) Sample of
vaccines and medical biological products as serum containing antibodies
imported for testing (the number of samples in accordance with provision for each
type of vaccine, medical bio-products).
2. Procedures:
Importing
enterprises shall send dossiers to the National Institute for Expertise of
Vaccines and Medical Biological Product. Within 07 working days from the date
of receiving the full samples and records as prescribed, the National Institute
for Expertise of Vaccines and Medical Biological Product shall send written
reply on the quality of vaccines, medical biological products and security on
animal experimented of the vaccines, medical bio-products sent to the
enterprises.
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RECORDS AND
PROCEDURES FOR EXPORT OF MEDICINES AND PACKAGING IN CONTACT WITH MEDICINES
Article 22. Narcotics, psychotropics drugs and pre-substance
1. Dossier:
a) Export orders
(Form 13a, 13b);
b) Written
permission for import of the competent authority of the importing country;
c) Addictive
finished medicines as a form of combination specified in clause 2 of Article 1
of Circular No.10/2010/TT-BYT dated 29/4/2010 guiding activities related to
addictive medicines; psychotropic finished medicines, pre-substance as a form
of combination prescribed in clause 2, Article 1 of Circular No.11/2010/TT-BYT
dated 29/4/2010 guiding activities related to psychotropic medicines,
pre-substances used as medicines of export as the sample for registration,
fairs, exhibitions, research are not required to have record as prescribed at
point b, clause 1 of this Article but must give written explanation of the
reason and purpose of exporting medicines of exporters;
d) For addictive
medicines, psychotropic drugs, pre-substances without registration numbers:
required to have enterprises’ commitments made under the export contract and
not permitted to circulate the products not granted yet circulation
registration numbers by the Ministry of Health.
2. Procedures:
Within 15 working
days from receipt of order, and valid dossiers, Drugs Administration Department
- Ministry of Health considers to grant the export license. In case of refusal,
Drugs Administration Department - Ministry of Health shall send written
replies, clearly stating the reasons.
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Medicines produced
domestically are granted certificates of free sale (FSC) or a certificate of
pharmaceutical product (CPP) for export. The number of FSC, CPP is issued at
the request of the establishments.
1. Dossier:
An written request
for a FSC or CPP (Form 14);
Where the
importing countries require the establishments to hand in a FSC or CPP in the
form prescribed by that State, the Drugs Administration Department-Ministry of
Health may review to grant FSC based on the form requested.
2. Procedures:
a) Procedures for
regranting FSC under the provisions of Article 13 of Decision No.10/2010/QD-TTg
dated 10/02/2010 of the Prime Minister defining the certificate of free sale
for the exports and imports.
b) Exporting
establishments of medicines are not required to make dossiers registration
procedures of traders for supply of FSC.
c) Within 05
working days from the date of receiving valid dossiers, Drugs Administration
Department - Ministry of Health grants FSC or CPP (Form 15a, 15b).
Chapter V
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Article 24. Handling of violations
1. In case the
exporters and importers commit acts of counterfeiting or arbitrarily repair
records, documents and legal documents of the authorities of Vietnam or of
foreign countries; use false seal or forge the signature or mark of the
importing establishments, manufacturing establishments and related
establishments in the records of export, import of medicines, Drugs
Administration Department-Ministry of Health sends a written warning to the
establishments and stop receiving, considering the records of export, import of
medicines of the establishments, specifically as follows:
a) Stop receiving,
reviewing records of export and import of medicines of the establishments,
within 03 months for the cases of first offense;
b) Stop receiving,
reviewing records of export and import of medicines of the establishments for
from 06 months to 12 months for the cases of violating 02 times within 12
months;
c) Depending on
the seriousness of violations and Drugs Administration Department-Ministry of
Health will send official dispatches to the manufacturers, companies providing
medicines and stop receiving and reviewing dossiers of registration of
medicines or stop receiving, reviewing operating registration dossiers on
medicines and medicine-making materials in Vietnam of the foreign companies.
Apart from the
above forms, Drugs Administration Department-Ministry of Health will disclose
violating contents of the establishments on the website of the Ministry of
Health; notify the Inspectorate, the customs authorities and other competent
authorities for consideration and handling according to the law regulations.
2. Violating
agencies, organizations and individuals, depending on the level of violations,
will be stoped receiving, reviewing records for export, import of medicines or
administratively sanctioned or examined for penal liability according to the
law regulations.
Chapter VI
IMPLEMENTATION
PROVISIONS
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This Circular
takes effect 45 days after its signing date. To annul Circular
No.06/2006/TT-BYT dated 16/05/2006 of the Ministry of Health guiding the export
and import of medicines and cosmetics; Circular No.13/1998/TT-BYT dated
15/10/1998 Ministry of Health guiding the receipt, management and use of
foreign aid medicines into Vietnam; the regulations on the import of vaccines
and medical biological products at Circular No.08/2006/TT-BYT dated 13/06/2006
of the Ministry of Health guiding the import of vaccines, medical biological
products; chemicals, insecticide, antibacterial substance used in appliances
and health and medical equipment.
During the
implementation, if any problems arises, the units need to report to Drugs
Administration Department - Ministry of Health for consideration and
settlement./.
FOR THE PRIME MINISTER
DEPUTY MINISTER
Cao Minh Quang
Form No. 12a
NAME OF THE IMPORTING
ENTERPRISE
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
________________________
IMPORT
ORDER FOR INGREDIENTS, EXCIPIENTS AND SEMI-FINISHED PRODUCTS OF MEDICINES
WITHOUT REGISTRATION NUMBERS
(Enterprise’s name) hereby
requests the Drug Administration of Vietnam, affiliated to the Ministry of
Health, to grant approval of import of ingredients or excipients used for
pharmaceutical production purposes as follows:
No.
Description
of ingredients, contents, dosage form and packing size
Unit
of measurement
Quantity
Quality
standard
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Name
of the supplier and its country
Registration
numbers of medicines formulated using semi-finished products requested for
import (if any)
1
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2
3
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It is to certify that the
import order, including ...page(s) and...clause(s) annexed to the Official
Document No. ...../QLD-KD dated…..(dd/mm/yyyy) of the Drug Administration of
Vietnam – the Ministry of Health, is approved.
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.
.....,
Date (dd/mm/yyyy)………….
Form No. 12b
NAME OF THE IMPORTING
ENTERPRISE
No…………………..
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
________________________
IMPORT
ORDER FOR EXCIPIENTS WITHOUT REGISTRATION NUMBERS
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No.
Description
of excipients
(Vietnamese
name) and receiving divisions
Scientific
name (in Latin)
Unit
of measurement
Quantity
Quality
standard
Origin
– Country of origin
Name
of the supplier and its country
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1
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3
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It is to certify that the
import order, including ...page(s) and...clause(s) annexed to the Official
Document No. ...../QLD-KD dated…..(dd/mm/yyyy) of the Drug Administration of
Vietnam – the Ministry of Health, is approved.
...
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......,
Date (dd/mm/yyyy)………….
Form No. 12c
NAME OF THE IMPORTING
ENTERPRISE
No…………………..
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
________________________
IMPORT
ORDER FOR PACKAGING IN DIRECT CONTACT WITH MEDICINAL PRODUCTS
(Enterprise’s name) hereby
requests the Drug Administration of Vietnam, affiliated to the Ministry of
Health, to grant approval of import of packaging in direct contact with
medicinal products used for pharmaceutical production purposes as follows:
...
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Description
of packaging in direct contact with medicinal products
Unit
of measurement
Quantity
Quality
standard
Name
of the manufacturer and its country
Name
of the supplier and its country
Remark
1
...
...
...
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2
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...
...
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TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
It is to certify that the
import order, including ...page(s) and...clause(s) annexed to the Official
Document No. ...../QLD-KD dated…..(dd/mm/yyyy) of the Drug Administration of
Vietnam – the Ministry of Health, is approved.
......,
Date (dd/mm/yyyy)………….