+7 (499) 340 10 14

Compliance Being Confirmed

The decree of the Ministry of Industry and Trade of the Russian Federation of 31.12.2015 No 4369 “On approval of Administrative Regulation on Rendering of Public Service of Issuing a Document Confirming that Production of a Medicinal Drug is Performed According to Good Manufacturing Practice and is Subject to Provision according to Requirements of Authorized Bodies of the  Country of Import of the Drug” is approved.

According to the decree each drug suggested for import abroad should be supported by a document, issued in the Ministry of Industry and Trade of the Russian Federation, confirming compliance of manufacture of the drug to good manufacturing practice (GMP). An application should be submitted for such a document, and information on the quality of three declared consecutive batched of the drug, covered by certificate, including analytical declarations / certificates of compliance for each batch, other documents, and information on approved documentation about the drug and a copy of certificate for trade mark (if applicable).

The minimum term of rendering the public service (it is free of charge) is 30 calendar days.

The document should be provided upon demand of an authorized body of a country where the drug is being imported.

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