Dossiers for import of medicines having valid registration number in Vietnam

Dossiers for import of medicines having valid registration number in Vietnam (Internet image) 

Articles 9 and 10 of Circular 47/2010/TT-BYT regulate dossiers for import of medicines having valid registration number in Vietnam as follows:

- For narcotics, psychotropic drugs and pre-substances used as medicines:

Dossier:

= Import order (Form 2a, 2b);

= Inventory report of addictive medicines (or psychotropic medicines, pre-substances used as medicines) (Form 3).

Procedures:

The enterprises send dossiers to the Drugs Administration Department-Ministry of Health off Vietnam. 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.

- For 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:

= The permit for circulating products or the decision to grant circulation registration numbers; other documents to allows the change, supplementation or corrections (if any);

= 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.

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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