FEDERAL LAW OF THE RUSSIAN FEDERATION

of December 29, 2015 No. 389-FZ

About modification of separate legal acts of the Russian Federation

Accepted by the State Duma on December 18, 2015

Approved by the Federation Council on December 25, 2015

Article 1

Part 3 of article 29 of the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; No. 42, Art. 5293; No. 49, Art. 6409; 2013, No. 48, Art. 6165; 2014, No. 43, Art. 5797; No. 52, Art. 7540; 29, the Art. 4367) to state 2015, to No. in the following edition:

"3. For medical application are enclosed to the application for confirmation of state registration of medicine the document confirming payment of the state fee for confirmation of state registration of medicine for medical application, the document containing results of monitoring of safety of medicine for the medical application which is carried out by the applicant in the form established by the corresponding authorized federal executive body, the document translated to the Russian confirming compliance of the producer of medicine for medical application to requirements of rules of proper production practice, issued by competent authority of the country of the producer of medicine for medical application and certified in accordance with the established procedure the document translated to Russian confirming compliance of the producer of pharmaceutical substance to requirements of rules of proper production practice, issued by competent authority of the country of the producer of pharmaceutical substance, certified in accordance with the established procedure and containing the name of pharmaceutical substance (international unlicensed or chemical and trade names), the name and the address of the producer of pharmaceutical substance, expiration date of pharmaceutical substance.".

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