New rules on licensing of the pharmaceutical activity in Russia

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Regulation of the Russian Government dated 22 December 2011 No. 1081 “On licensing of the pharmaceutical activity” (“Regulation on licensing of the pharmaceutical activity”) entered into force on 7 January 2012. The Regulation on licensing of the pharmaceutical activity was adopted as a follow-up to Federal law dated 4 May 2011 No. 99-FZ “On licensing of certain types of activities” (“Law on licensing”), thus revoking the previously-effective Regulation of the Russian Government dated 6 July 2006 No. 416 “On approving of the rules on licensing of the pharmaceutical activity”. It should be pointed out that under section 4 article 9 of the Law on licensing, a pharmaceutical license has no fixed expiration date.

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