Title: Circular 38/2013/TT-BYT Amendment and supplementation of a number of articles of Circular 47/2010/TT-BYT Guiding import and export of medicines and packaging directly contacted with medicines

Type: Circular

Issuing Agency: Ministry of Health

Responsible Agency: Ministry of Health

Issuing Date: 15-11-2013

 

Article 1. Amendment and supplementation of a number of articles of Circular No.47/2010/TT-BYT of December 29, 2010 of the Minister of Health guiding import and export of medicines and packaging directly contacted with medicines (below collectively preferred to Circular No.47/2010/TT-BYT) as follows:

1. Clause 3 of Article 4 is amended as follows:

“3. Requirements for testing slips:

When conducting clearance procedures, enterprises importing medicines or packaging directly contacted with medicines will have to submit the Customs of border gates the original testing slip of manufacturers verifying quality satisfaction for each lot of imported medicines of such manufacturers, except pharmaceutical materials and medicines prescribed in Articles 12, 13, 14, 15, 17 and 18 of this Circular.

In case that 02 or more manufacturers participating in production of medicines, original testing slip of the manufacturer or original testing slip of the final packaging unit or the unit that is responsible for sending out of the factory.

The Customs of border gates will keep copy of testing slips stamped with verification of importing enterprises”.

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