On January 19, 2018 State Duma has passed in the first reading the introduced by Russian Government draft law1 (hereinafter – the “Draft law”) providing changes to the Federal law dated 12.04.2010 No. 61-FZ “On drugs (medicines) circulation” (hereinafter – “61-FZ”).
The main changes proposed by the Draft law include the following:
1. Securing the right of foreign drugs (medicines) manufacturers to submit the decision on carrying out an audit instead of a GMP certificate