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New rules on licensing of the pharmaceutical activity in Russia

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.

In this alert we will discuss the following key issues of the Regulation on licensing of the pharmaceutical activity:

  • list of activities which constitute pharmaceutical activity;
  • licensing authorities;
  • licensing requirements;
  • documents for obtaining a pharmacy license.

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