FEDERAL LAW OF THE RUSSIAN FEDERATION

of July 24, 2023 No. 341-FZ

About introduction of amendments to article 45 of the Federal law "About Drug Circulation"

Accepted by the State Duma on July 12, 2023

Approved by the Federation Council on July 19, 2023

Bring in article 45 of the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; 2012, No. 26, Art. 3446; 2014, No. 43, Art. 5797; No. 52, Art. 7540; 2015, No. 51, Art. 7245; 2016, No. 27, Art. 4194; 2017, No. 31, Art. 4827; 2019, No. 31, Art. 4456; No. 52, Art. 7780, 7799; 2020, No. 52, Art. 8590; 2022, No. 29, Art. 5278) following changes:

1) in part 4 the first offer to state in the following edition: "In case of production of medicines for medical application pharmaceutical substances, data on which contain in the state register of medicines for medical application and (or) the unified register of the registered medicines of the Eurasian Economic Union, except for the pharmaceutical substances made for performing clinical trials and (or) for export, are used.", to add with the new second offer of the following content: "In case of production of medicines for veterinary application pharmaceutical substances, data on which contain in the state register of medicines for veterinary application, and (or) the state register of medicines for medical application, and (or) the unified register of the registered veterinary medicines of the Eurasian Economic Union, and (or) the unified register of the registered medicines of the Eurasian Economic Union, except for the pharmaceutical substances made for performing clinical trials and (or) for export, are used.";

Item 1 of part 5 to state 2) in the following edition:

"1) medicines, data on which do not contain in the state register of medicines for medical application, and (or) the state register of medicines for veterinary application, and (or) the unified register of the registered medicines of the Eurasian Economic Union, and (or) the unified register of the registered veterinary medicines of the Eurasian Economic Union, except for the medicines made for performing clinical trials or for export;".

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