Documentation for import of finished medicines containing pharmaceutical substance without registration number in Vietnam

Documentation for import of finished medicines containing pharmaceutical substance without registration number in Vietnam (Internet image)

Article 11 of Circular 47/2010/TT-BYT stipulates as follows:

- Conditions and number of medicines considered for import permits: Comply with the provisions of Article 7 of Decision 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.

- Dossier:

+ Import order (Form 5a, 5b, 5c, 5d, 5đ);

+ 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;

+ Standard and testing methods of quality of medicines;

+ 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;

+ The inventory report for addictive medicines, psychotropic drugs and pre-substances used as medicine (Form 3);

+ Preclinical and clinical records for medicine containing new pharmaceutical substances, medicines with new combinations of circulating pharmaceutical substances.

- 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.

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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