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FEDERAL LAW OF THE RUSSIAN FEDERATION

of March 8, 2015 No. 55-FZ

About introduction of amendments to the Federal law "About Bases of Protection of Public Health in the Russian Federation" concerning the organization of the medical care provided within clinical approbation of methods of prevention, diagnostics, treatment and rehabilitation

Accepted by the State Duma on February 27, 2015

Approved by the Federation Council on March 4, 2015

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. 39, Art. 4883; No. 48, Art. 6165; 2014, No. 30, Art. 4257; No. 43, Art. 5798; No. 49, Art. 6927; 2015, No. 1, Art. 85) following changes:

Part 1 of Article 14 to add 1) with Item 11.2 of the following content:

"11. 2) the organization of delivery of health care within clinical approbation of methods of prevention, diagnostics, treatment and rehabilitation (further - clinical approbation) the medical organizations subordinated to federal executive bodies;";

Shall be replaced with words 2) in part 5 of Article 26 of the word "Testing of New Methods of Prevention, Diagnostics, Treatment, Medical Rehabilitation, and also" "Clinical approbation, testing", shall be replaced with words the words "it is not allowed" "are not allowed";

To add 3) with Article 36.1 of the following content:

"Article 36.1. Features of the medical care provided within clinical approbation

1. Clinical approbation represents practical application developed and earlier not applied methods of prevention, diagnostics, treatment and rehabilitation in case of delivery of health care for confirmation of proofs of their efficiency.

2. Medical care within clinical approbation is provided in the presence of the conclusions of ethical committee and advisory council of authorized federal executive body. Regulations on ethical committee and advisory council, their structures and procedure for pronouncement of the corresponding conclusions by them affirm authorized federal executive body.

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