FEDERAL LAW OF THE RUSSIAN FEDERATION

of April 30, 2021 No. 128-FZ

About introduction of amendments to the Federal law "About Bases of Protection of Public Health in the Russian Federation" and articles 12 and 22 of the Federal law "About Licensing of Separate Types of Activity"

Accepted by the State Duma on April 22, 2021

Approved by the Federation Council on April 23, 2021

Article 1

Bring in the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation" (The Russian Federation Code, 2011, No. 48, Art. 6724; 2012, No. 26, Art. 3446; 2013, No. 48, Art. 6165; 2014, No. 30, Art. 4257; No. 49, Art. 6927; 2015, No. 1, Art. 85; No. 10, Art. 1425; No. 27, Art. 3951; No. 29, Art. 4397; 2016, No. 1, Art. 9; No. 15, Art. 2055; No. 18, Art. 2488; No. 27, Art. 4219; 2017, No. 31, Art. 4765, 4791; No. 50, Art. 7544, 7563; 2018, No. 32, Art. 5092; No. 53, Art. 8437; 2019, No. 22, Art. 2675; No. 52, Art. 7770, 7799, 7836; 2020, No. 13, Art. 1856; No. 14, Art. 2028; No. 29, Art. 4516; No. 52, Art. 8584) following changes:

Item 15 of part 1 of Article 14 to state 1) in the following edition:

"15) monitoring of safety of medical products, registration of the side effects which are not specified in the instruction for application or the operation manual on medical product, undesirable reactions in case of its application, features of interaction of medical products among themselves, the facts and circumstances creating threat of life and to health of citizens and health workers in case of application and operation of medical products (further - unfavorable events);";

2) in Article 38:

a) add with parts 3.1 and 3.2 of the following content:

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