FEDERAL LAW OF THE RUSSIAN FEDERATION

of June 4, 2018 No. 140-FZ

About introduction of amendments to the Federal law "About Drug Circulation"

Accepted by the State Duma on May 17, 2018

Approved by the Federation Council on May 30, 2018

Bring in 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. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 43, Art. 5797; No. 52, Art. 7540; 2015, No. 29, Art. 4367; 2016, No. 1, Art. 9; 2018, No. 1, Art. 9) following changes:

Item 2 of part 6 of Article 13 to state 1) in the following edition:

"2) one medicine provided on state registration concerning the same holder or the owner of the registration certificate of medicine in the form of two and more medicines under different trade names.";

Article 16 to add 2) with parts 4.2 and 4.3 of the following content:

"4.2. If as a part of the registration file on medicine for medical application 18, part 1.1 of Article 30 and article 34 of this Federal Law the copy of the solution of authorized federal executive body on conducting inspection of the producer of medicines contains stipulated in Article, before registration of results of examination of medicine it is provided to the expert according to the procedure and on conditions which are provided by parts 4 and 4.3 of this Article, the copy of the conclusion about compliance of the producer of medicines to requirements of rules of proper production practice issued by authorized federal executive body.

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