FEDERAL LAW OF THE RUSSIAN FEDERATION

of December 30, 2021 No. 482-FZ

About introduction of amendments to the Federal law "About Bases of Protection of Public Health in the Russian Federation"

Accepted by the State Duma on December 22, 2021

Approved by the Federation Council on December 24, 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; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2016, No. 27, Art. 4219; 2017, No. 31, Art. 4791; 2018, No. 53, Art. 8415; 2019, No. 10, Art. 888; 2021, No. 27, Art. 5143, 5159) following changes:

Article 20 to add 1) with part 12 of the following content:

"12. In case of rendering medical care to the minor the attending physician shall inform the minor who reached age, established by part 2 of article 54 of this Federal Law, one of parents or other legal representative of the minor who did not reach this age about the applied medicine including applied according to indicators (characteristics) of medicine which are not specified in the instruction for its application about its safety expected efficiency, risk degree for the patient and also about actions of the patient in case of unexpected effects of influence of medicine on the state of health of the patient.";

2) Article 37 to add with part 14.1 following of content:

"14.1. In standards of medical care to children and clinical recommendations inclusion of the medicine registered in the territory of the Russian Federation applied according to indicators (characteristics) of medicine which are not specified in the instruction for its application in case of compliance of such medicine to the requirements established by the Government of the Russian Federation is allowed. The list of diseases or conditions (groups of diseases or conditions) in case of which use of medicine according to indicators (characteristics) of medicine which are not specified in the instruction for its application is allowed is established by the Government of the Russian Federation.";

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