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:

a) Enterprises having certificates of eligibility for medicine trading and medicine warehouses obtaining standard "Good Storage Practice" (GSP) are imported directly and received entrusting to import finished medicines and raw materials for making medicines, vaccines and medical biological products, medicines from medicinal material, traditional medicines, radioactive medicines are exempted from declaration licensing in accordance with the business scope stated in the certificate of eligibility for medicine trading and GSP certificate;

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).

7. The establishments having function of research and testing, the medicine production establishments are permitted to import medicines for research and testing.

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.

General provisions on import and export of medicines

1. Medicine quality, packaging in direct contact with imported medicines

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.

3. Requirements for testing sheet:

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.

6. Labels of imported medicines:

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:

Enterprises importing medicines must pay fees as prescribed in Decision No.44/2005/QD-BTC 12/07/2005 of the Minister of Finance stipulating the regime of collection, remittance, management and use of fees for appraising trade, commerce with conditions in the field of health, fees of criteria evaluation and conditions for practicing medicine, fees for licensing import, export and certificate of practicing medicine, pharmacy; Decision No.59/2008/QD-BTC dated 21/07/2008 on amending and supplementing Decision No.44/2005/QD-BTC dated 12/07/2005 of the Minister of Finance stipulating the regime of collection, remittance, management and use of fees for appraising trade, commerce with conditions in the field of health, fees of criteria evaluation and conditions for practicing medicine, fees for licensing import, export and certificate of practicing medicine, pharmacy and other concerned legal documents.

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;

- If the medicine is produced through many stages in different countries, it can not be identified the sole country of origin, the importing establishment of medicine must hand in CPP of the country producing the final dosage form or CPP of the country sending factory’s output. Where there is no CPP of both countries of origin above, the Drugs Administration Department - the Ministry of Health will consider the CPP acceptance of the country where the product is shipped to the importing country;

- 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.

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