of October 22, 2014 No. 313-FZ
About introduction of amendments to the Federal law "About Drug Circulation"
Accepted by the State Duma on October 7, 2014
Approved by the Federation Council on October 15, 2014
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; 2012, No. 26, Art. 3446; 2013, No. 48, Art. 6165) following changes:
The subitem "e" of Item 16 of part 3 of article 18 after the words "including" to add 1) with words of "medicine for medical application";
2) in Item 3 of part 1 of Article 19 of the word "subitems "a" - "д", - "m" shall be replaced with words "subitems "a" - "m";
3) regarding 1 Article 24 of the word "subitems "a" - "д", - "m" shall be replaced with words "subitems "a" - "m";
4) in Article 29:
a) "federal executive body" to add part 3 after words with words ", and also the documents specified in Items 2 and 5 of part 3 of article 18 of this Federal Law";
b) add with part 8 of the following content:
"8. The basis for refusal in confirmation of state registration of medicine is the solution of the corresponding authorized federal executive body that quality and (or) efficiency of medicine are not confirmed with the obtained data or that the risk of damnification to health of the person or animal owing to acceptance of medicine exceeds efficiency of its application.";
5) in Article 31:
a) state part 2 in the following edition:
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