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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of September 2, 2008 No. 1269

About approval of the Regulations on state registration (re-registration) of products of medical prescription and medical equipment

(The last edition from 06-06-2017)

According to part four of article 39-1 of the Law of the Republic of Belarus of June 18, 1993 "About health care" in edition of the Law of the Republic of Belarus of June 20, 2008 the Council of Ministers of the Republic of Belarus DECIDES:

1. Approve the enclosed Regulations on state registration (re-registration) of products of medical prescription and medical equipment.

2. Voided.

3. Recognize invalid:

the resolution of Council of Ministers of the Republic of Belarus of June 20, 2000 No. 921 "About approval of the Regulations on state registration of medicines and pharmaceutical substances and Regulations on state registration of products of medical prescription and medical equipment" (The national register of legal acts of the Republic of Belarus, 2000, No. 64, 5/3514);

the resolution of Council of Ministers of the Republic of Belarus of October 11, 2001 No. 1476 "About modification and amendments in resolutions of Council of Ministers of the Republic of Belarus of December 7, 1998 No. 1870 and of June 20, 2000 No. 921" (The national register of legal acts of the Republic of Belarus, 2001, No. 100, 5/9224);

subitem 1.34 of Item 1 of the resolution of Council of Ministers of the Republic of Belarus of August 2, 2006 No. 990 "About modification and amendments in some orders of the Government of the Republic of Belarus and recognition voided the separate orders of the Government of the Republic of Belarus in connection with reorganization of system of republican state bodies" (The national register of legal acts of the Republic of Belarus, 2006, No. 146, 5/22839).

4. To the Ministry of Health in three-months time to bring the regulatory legal acts into accord with this resolution and to take other measures for its realization.

5. This resolution becomes effective since September 1, 2008.

First Deputy Prime Minister of the Republic of Belarus

V. Semashko

Approved by the Resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269

Regulations on state registration (re-registration) of medicines and pharmaceutical substances

Voided according to the Resolution of Council of Ministers of the Republic of Belarus of 01.04.2015 No. 254

Approved by the Resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269

Regulations on state registration (re-registration) of products of medical prescription and medical equipment

Chapter 1. General provisions

1. This Provision developed based on part four of article 39-1 of the Law of the Republic of Belarus of June 18, 1993 "About health care" in edition of the Law of the Republic of Belarus of June 20, 2008 (Vyarkho¸naga Savet's Vedamastsi of Respubliki Belarus, 1993, No. 24, Art. 290; The National register of legal acts of the Republic of Belarus, 2008, No. 159, 2/1460), is determined procedure for state registration (re-registration) for products of medical prescription and medical equipment in the Republic of Belarus. The provision is obligatory for the legal entities and individual entrepreneurs performing production, import, realization and use of products of medical prescription and medical equipment.

2. In this Provision the main 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:

safety of products of medical prescription and medical equipment – the positive product characteristic of medical prescription and medical equipment based on risk assessment of possible damnification of life, to health of the person and the environment;

state registration of products of medical prescription and medical equipment - system of the admission to production, realization and medical application of products of medical prescription and the medical equipment made in the Republic of Belarus or arriving because of its limits which are acknowledged conforming to the requirements for safety, efficiency and quality for the person established in the Republic of Belarus;

The state register of products of medical prescription and medical equipment of the Republic of Belarus (further - the State register) - the document containing data on the products of medical prescription and medical equipment registered in the Republic of Belarus and permitted to production, realization and medical application;

products of medical prescription - products and auxiliary materials used for prevention, diagnosis, treatment, rehabilitation, prosthetics of the population, research works in the field of health care;

product quality of medical prescription and medical equipment - set of the properties and product characteristics of medical prescription and medical equipment influencing their capability to be effective to destination on condition of compliance to requirements of technical regulatory legal acts in the field of technical regulation and standardization;

medical equipment - the medical devices, devices and the equipment used separately in complexes or systems in the medical purposes for prevention, diagnosis, treatment, rehabilitation, prosthetics of the population, research works in the field of health care;

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