Management forms of import and export of medicines in Vietnam

Recently, the Ministry of Health issued Circular 47/2010/TT-BYT guiding the export, import of medicines and packaging in direct contact with medicines, including regulations on management forms of import and export of medicines and packaging in contact with medicines in Vietnam.

Management forms of import and export of medicines in Vietnam

Management forms of import and export of medicines in Vietnam (Internet image)

According to Articles 7 and 8 of Circular 47/2010/TT-BYT:

- Import of medicines, the packaging in direct contact with medicines in Vietnam

+ 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).

+ 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.

+ Medicines, packaging in direct contact with imported medicines required to have import permit by the Drugs Administration Department-Ministry of Health include:

  •  Addictive medicines, psychotropic drugs, pre-substances used as medicines, including those in single or mixed substances with the valid circulation registration numbers;
  •  Finished medicines, raw materials used for making medicines, vaccines and medical biological products without the registration number;
  •  Packaging in direct contact with medicines.

- Export of medicines, packaging in direct contact with medicines in Vietnam

+ 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.

+ 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.

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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