of August 4, 2023 No. 466-FZ
About introduction of amendments to article 4 of the Federal law "About Drug Circulation" and the Federal Law "About Biomedical Cellular Products"
Accepted by the State Duma on July 20, 2023
Approved by the Federation Council on July 28, 2023
Item 6.2 of article 4 of the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; 2011, No. 50, Art. 7351; 2013, No. 48, Art. 6165; 2014, No. 52, Art. 7540; 2015, No. 29, Art. 4367; 2017, No. 31, Art. 4791; 2018, No. 1, Art. 9; 2019, No. 31, Art. 4456; No. 52, Art. 7793; 2020, No. 14, Art. 2035; No. 29, Art. 4516; 2022, No. 1, the Art. 32) to add with words ", medicines on the basis of somatic cages".
Bring in the Federal Law of June 23, 2016 No. 180-FZ "About biomedical cellular products" (The Russian Federation Code, 2016, No. 26, Art. 3849; 2018, No. 32, Art. 5116; 2021, No. 24, Art. 4188; 2022, No. 11, Art. 1596) following changes:
1) regarding 1 Article 1 of the word "import to the Russian Federation," to exclude;
2) in Article 2:
a) state Item 1 in the following edition:
"1) biomedical cellular product - the complex consisting of the cellular line (cellular lines) and excipients or of the cellular line (cellular lines) and excipients in combination with the medicines which underwent state registration for medical application (further - medicines), and (or) the pharmaceutical substances included in the state register of medicines and (or) medical products. Objects of transplantation, and also high-tech medicines, including the gene and therapeutic medicines which are subject to registration according to the right of the Eurasian Economic Union and (or) state registration according to the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" do not belong to biomedical cellular products;";
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