FEDERAL LAW OF THE RUSSIAN FEDERATION

of November 28, 2018 No. 449-FZ

About modification of separate legal acts of the Russian Federation concerning input in civil circulation of medicines for medical application

Accepted by the State Duma on November 20, 2018

Approved by the Federation Council on November 23, 2018

Article 1

Item 2 of article 12 of the Federal Law of September 17, 1998 No. 157-FZ "About immunoprevention of infectious diseases" (The Russian Federation Code, 1998, No. 38, Art. 4736; 2009, No. 1, Art. 21; 48, the Art. 6165) to state 2013, to No. in the following edition:

"2. Immunobiological medicines for immunoprevention are subject to input in civil circulation according to the procedure, the established legislation of the Russian Federation on drug circulation.".

Article 2

Item 4 of article 1 of the Federal Law of December 27, 2002 No. 184-FZ "About technical regulation" (The Russian Federation Code, 2002, No. 52, Art. 5140; 2007, No. 19, Art. 2293; No. 49, Art. 6070; 2011, No. 30, Art. 4603; No. 49, Art. 7025; 2012, No. 50, Art. 6959; 2015, No. 48, Art. 6724; 2016, No. 15, of the Art. 2066) after words "sanitary and epidemiologic requirements," to add with words "requirements in the field of drug circulation,".

Article 3

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. 31, Art. 4161; 2011, No. 50, Art. 7351; 2012, No. 26, Art. 3446; No. 53, Art. 7587; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 43, Art. 5797; No. 52, Art. 7540; 2015, No. 29, Art. 4367, 4388; 2016, No. 27, Art. 4238; 2017, No. 31, Art. 4827; 2018, No. 1, Art. 9) following changes:

Article 5 to add 1) with Item 25 of the following content:

"25) issue of permissions to input in civil circulation of immunobiological medicines.";

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