The Russian Association of International Pharmaceutical Manufacturers (AIPM) is asking for changes to the rules for the introduction of unlabeled drugs into civil circulation.
It proposes removal of the clause that, in order to obtain the consent of the interagency commission it is necessary to attach copies of contracts for the supply and installation of equipment for applying codes, as well as for software development. This information cannot be provided without permission from counterparties, the trade group points out.
The AIPM proposes amendments to subparagraph c) of paragraph 7 of the Decree of the Government of the Russian Federation on the provisional procedure for the introduction of unlabeled drugs into civilian traffic. Instead of copies of contracts for the supply and installation of equipment for applying codes, as well as for the development of software, it is advisable to limit ourselves to simple confirmation of the existence of such contracts. This is stated in a letter from the AIPM dated July 15, sent to the Deputy Prime Minister of Russia, Tatyana Golikova.
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