+7 (499) 340 10 14

To Accelerate Marketing Authorization

A draft of amendments into the law “On Drug Circulation” suggested by the Ministry of Industry and Trade of the Russian Federation has been published.

The project concerns simplification of GMP registration for international manufacturers, who, according to the amendments proposed, may submit drugs for marketing authorization with GMP certificate, and a copy of resolution of the Ministry of Industry and Trade for inspection of the manufacturing site. It will significantly accelerate the process of marketing authorization, its time limits were extended in connection with the need to provide a conclusion on compliance fo international manufacturer with good manufacturing practice in the marketing authorization dossier, issued by the Ministry of Industry and Trade of the Russian Federation. If amendments are to be adopted, marketing authorization of the drug and certification of manufacturing capacities according to GMP may be simultaneous.

Besides, amendments show that copies of conclusion on drug manufacturer’s compliance with GMP, issued to the manufacturing sites of the drug being authorized, the manufacturer may provide a copy of solution on inspection of drug manufacturer, if it is manufactured outside Russia. If at the time of decision on marketing authorization there is no information on issue or refusal to issue a conclusion on compliance of international manufacturer with GMP, the Ministry of Health should send to the applicant a request to specify information which the applicant is expected to respond to within 180 days.

Amendments also specify that manufacturer that received refusal of approval because of failure to provide the GMP certificate, will be able to resubmit documents for marketing authorization. But in that case a copy of decision on inspection will not be accepted, and the manufacturer will have to submit a GMP certificate. Making decision on registration, the Ministry of Health will take into account the earlier performed expertise of the drug.

The Ministry of Industry and Trade  proposes to introduce the corresponding amendments into the law “On Drug Circulation”. If the amendments are approved, the federal law will come into effect on January 1, 2017.

Public discussion will continue to December 2, 2016.

^
LABMGMU LABMGMU +7 (499) 340 10 14 info@labmgmu.ru 119435, Moscow, Malaya Pirogovskay str. 13-1, floor 4