Industry ministry documents

Answer:

  Currently, the import of medicines and empty capsules used in pharmaceuticals is carried out in accordance with Circular 47/2010 / TT-BYT dated December 29, 2010 guiding the import and export of drugs and packaging in direct contact with drugs of Ministry of Health and Circular 38/2013 / TT-BYT dated November 15, 2013 of the Ministry of Health instructing to supplement the Circular 47/2010 / TT-BYT. Whereby:

 1 / Drugs with circulation registration numbers are still valid, imported according to demand without having to apply for import licenses or certification of import orders.

 Drugs, packages directly exposed to imported drugs must have an import permit of the Drug Administration of the Ministry of Health, including:

 Finished drugs, raw materials for making medicines, vaccines and medical biologicals have no registration number;

Packaging in direct contact with drugs.

  When carrying out customs procedures, enterprises importing drugs and packages in direct contact with medicines must produce the original border-gate customs offices the testing cards of production establishments certifying the quality standards for each lot of imported medicines. manufacturer's password

Traders who import drugs and packages in direct contact with medicines must take responsibility for the quality and safety of imported drugs according to the provisions of the Pharmacy Law, the Commercial Law and other regulations on quality management of current medicines. onions.

2. Shelf-life of imported drugs:

 Finished drugs imported into Vietnam have a shelf life of more than 24 months, the remaining shelf life must be at least 18 months from the date of arrival in Vietnam. For drugs with a use duration of 24 months or less, the use duration must be at least 12 months from the date of arrival in Vietnam;