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;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info