Draft law on accelerated registration of foreign medicines approved in Russia

Print 01 December 2017
GMP News

At a meeting held on November 23, 2017, the Government of the Russian Federation approved the draft federal law “On Amendments to the Federal Law on the Circulation of Medicines” and decided to submit it to the State Duma in accordance with the established procedure.

The purpose of the draft law is to regulate the issues of state registration of medicines that have the same international nonproprietary name (INN), but different trade names, and were manufactured at the same production site. This will reduce the period required for making the medicines available in the Russian market, facilitate the development of contract manufacturing of medicinal products in Russia by allowing the Russian pharmaceutical manufacturers to produce medicines of other manufacturers in addition to their own products.

The draft law proposes to amend the articles 16, 17, 18, 29, 30 and 31 of the Federal Law in order to allow the foreign manufacturers of medicines to submit a copy of the decision adopted by the authorized federal executive body on the inspection of the foreign manufacturer, if it has no conclusion regarding conformity of the manufacturer of the medicine to the requirements of good manufacturing practices issued by the authorized federal executive body, as part of the registration dossier submitted for the state registration, and as part of the document set required in order to confirm the registration of medicine and introduce changes to the registration dossier.

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