Guidance on making of goods orders, languages ​​and forms of import dossier of medicines​ in Vietnam

Guidance on making of goods orders, languages ​​and forms of import dossier of medicines​ in Vietnam (Internet image) 

Article 5 of Circular 47/2010/TT-BYT guiding the making of goods orders, languages ​​and forms of  import dossier of medicines in Vietnam as follows:

- Order of import and export of medicines, packaging in direct contact with the medicines is made in 03 copies in the form appropriate to each medicine prescribed in this Circular. After being approved, 02 copies shall be kept at the Drugs Administration Department - the Ministry of Health, 01 copy is sent to the importing, exporting enterprises of medicines. The copy sent to the importing, exporting enterprises of medicines is stamped "dispatch for enterprise" for making customs procedures at border gates. Order of import and export of narcotics, psychotropic drugs, pre-substances used as medicines, including the types of single substances or in combination with the valid circulation registration numbers are made into 02 copies.

- Where enterprises receiving entrusting of import and export of medicines, it must specify the name of the entrusting company of importing, exporting medicines on the order.

- Files, documents attached to orders to be prepared on A4 size paper, bound into 01 sets firmly. Dossiers must be sorted by the right order of cataloging, which are separated between the parts. The separated parts must be numbered for easy reference and stamped certification by importing enterprise in the first page of each part of the entire dossier and stating clearly on the cover page: name the importer, order number, date of order, and kind of order.

- The language used in the medicine import dossiers:

Dossier of foreign medicines import must be written in Vietnamese or English. If the dossier is written in English, the information in the instruction manual of medicine must be written in Vietnamese, except for the following contents are allowed to write in other languages with Latin root words:

+ Name of proprietary medicines, international nonproprietary or generic name of the medicine;

+ International nonproprietary names or scientific names of ingredients, ingredient quantities of medicines in the cases of unable to translate into Vietnamese or translated into Vietnamese but it is nonsense;

+ Name and address of the foreign enterprises of production, manufacture franchise of medicines.

- For finished medicines without import registration number under the provisions of Article 11 of this Circular, each medicine must be made in a separate order, except for medicines that share all the following elements can be imported in same dossier:

+ Name of medicine;

+ Dosage form;

+ The formula for a dose unit (for the medicine form of single dose) or the same concentration content (for multi-dose medicine);

+ 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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