LAW OF THE REPUBLIC OF BELARUS

of October 25, 2023 No. 308-Z

About change of the laws concerning health care

Accepted by the House of Representatives on September 19, 2023

Approved by Council of the Republic on October 9, 2023

Article 1. Bring in the Law of the Republic of Belarus of June 18, 1993 No. 2435-XII "About health care" the following changes:

1. In Article 1 part one:

after the paragraph of the ninth to add part with the paragraph of the following content:

"counterfeit medical product (product of medical appointment, medical equipment) - the medical product (product of medical appointment, medical equipment) issued or which is in circulation with violation of the law in the field of intellectual property;";

after the paragraph of the twenty fifth to add part with paragraphs of the following content:

"unfavorable event (incident) - any defect and (or) deterioration in characteristics either violation of functioning of medical product, or its discrepancy to requirements for safety, efficiency, quality and accompanying information (documentation), either insufficiency or incorrectness of accompanying information (documentation) on medical product, or the collateral reaction or by-effect which is not specified in the instruction for application (operation manual) which directly or indirectly brought or could lead to death or serious deterioration in the state of health of users of this medical product or the third parties;

the low-quality medical product - medical product which does not conform to requirements for safety to efficiency, quality of medical products, requirements to marking, technical and operational documentation and cannot be safely used for designated purpose, established by the producer;";

to add the paragraph of the twenty seventh with the words "and (or) concerning which medical expertize is carried out";

after the paragraph of the thirty second to add part with the paragraph of the following content:

"counterfeited medical product - the medical product intentionally accompanied with false information about its structure, characteristics and (or) the producer;";

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