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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of March 14, 2024 No. 177

About questions of the address of medical products

Based on parts nine and the thirteenth article 39-1 of the Law of the Republic of Belarus of June 18, 1993 "About health care" the Council of Ministers of the Republic of Belarus DECIDES: No. 2435-XII

1. Approve:

The regulations on procedure for collection, registration and information analysis on unfavorable events (incidents) connected with medical application (operation) of medical products (are applied);

The regulations on procedure and conditions of retirement, return to the producer (his authorized representative) or destructions of medical products (are applied).

2. In this resolution terms and their determinations in the values established by the Law of the Republic of Belarus "About health care" and also the following terms and their determinations are used:

the owner of medical products – the legal entity or the individual entrepreneur at whom medical products are in property or are transferred to them on the right of economic maintaining or operational management;

corrective action on safety of medical product (further – corrective action) – action taken for the purpose of decrease in risk of death or serious deterioration in the state of health of the users or the third parties connected with medical application (operation) of medical product;

collateral reaction – any adverse clinical manifestation for the user's organism caused by medical application (operation) of medical product;

by-effect – any adverse clinical manifestation for the user's organism revealed during medical application (operation) of medical product irrespective of cause and effect relationship availability with medical application (operation) of medical product;

the user – the patient, the health worker or other physical person applying (operating) medical product to destination, determined by the producer of medical product;

serious health hazard of the user – any unfavorable event (incident) which requires rendering emergency medical service to the user, including surgical intervention, for the purpose of prevention of irreversible defeat of function of organism of the user or irreversible damage of structure of body of the user;

accompanying information (documentation) – marking, the instruction for application (operation manual) and the other information relating to identification, the description, appointment, rules of medical application (operation) of medical product except shipment documents;

the subject of the address of medical products – the legal entity, the individual entrepreneur registered in the Republic of Belarus, representative office of the foreign organization, who are carrying out technical testing, researches (testing) for the purpose of assessment of biological effect, the clinical testing, examination of safety, quality and efficiency of medical products performing their registration, production (production), storage, transportation, realization, installation, adjustment, medical application (operation), maintenance, repair, destruction of medical products;

destruction of medical products – actions for mechanical damage of medical products, their separation into the components, including the department from packaging resulting in impossibility of their proper use, determined by the producer of medical products;

the authorized representative of the producer of medical products – the legal entity, the individual entrepreneur registered in the Republic of Belarus, representative office of the foreign organization, authorized based on the power of attorney of the producer of medical products to represent its interests concerning the address of medical products.

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