of December 28, 2025 No. 504-FZ
About introduction of amendments to articles 4 and 43 of the Federal law "About Drug Circulation" and articles 1 and 4 of the Federal Law "About introduction of amendments to the Federal law "About Drug Circulation" and articles 1 and 4 of the Federal Law "About introduction of amendments to the Federal law "About Drug Circulation" and the Federal Law "About introduction of amendments to the Federal law "About Drug Circulation"
Accepted by the State Duma on December 17, 2025
Approved by the Federation Council on December 19, 2025
Bring in 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. 43, Art. 5797; 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, Art. 32; 2023, No. 32, Art. 6198; 2024, No. 6, Art. 764; 2025, No. 30, Art. 4417) following changes:
Item 49 of Article 4 to state 1) in the following edition:
"49) the information leaflet of the patient - the document which is processed in document type on paper signed by the patient or his legal representative, or is created in electronic form, signed by the patient or his legal representative with use of the strengthened qualified digital signature, or the strengthened unqualified digital signature, or the simple digital signature by means of application of single system of identification and authentication and in which contain in available form of the data, concerning the conducted clinical trial of medicine, and the voluntary consent of the patient to participation in clinical trial of medicine expressed in writing for medical application after acquaintance of the patient or his legal representative with the features of clinical trial important for expression of such consent;";
2) in Article 43:
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