Legal documents in import dossier of medicines in Vietnam

Legal documents in import dossier of medicines in Vietnam (Internet image) 

Clause 11, Article 4 of Circular 47/2010/TT-BYT regulates legal documents in import dossier of medicines in Vietnam:

- 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.

- 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.

- 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.

- 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.

More details can be found in Circular 47/2010/TT-BYT, which comes into force from February 12, 2011.

Nguyen Phu

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