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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of April 1, 2015 No. 254

About state registration (confirmation of state registration) of medicines

(as amended on 27-10-2020)

Based on parts eight, the tenth, twelfth and twenty fifth article 10 of the Law of the Republic of Belarus of July 20, 2006 "About drug circulation" the Council of Ministers of the Republic of Belarus DECIDES: No. 161-Z

1. Approve:

The regulations on procedure and conditions of implementation of state registration (confirmation of state registration) of medicines (are applied);

The regulations on structure, procedure for forming and maintaining the State register of medicines of the Republic of Belarus (are applied).

2. Bring in the 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 medicines and pharmaceutical substances and Regulations on state registration (re-registration) of products of medical prescription and medical equipment" (The national register of legal acts of the Republic of Belarus, 2008, No. 213, 5/28269; 2009, No. 66, 5/29385; 2010, No. 6, 5/30980; No. 251, 5/32615; National legal Internet portal of the Republic of Belarus, 24.10. 2012, 5/36375; 13:08. 2014, 5/39243) following changes and amendments:

2.1. to state the name of the resolution in the following edition:

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

2.2. "and part ten of article 8 of the Law of the Republic of Belarus of July 20, 2006 "About medicines" to exclude from word preamble;

2.3. state Item 1 in the following edition:

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

2.4. To declare the regulations on state registration (re-registration) of medicines and pharmaceutical substances approved by this resolution invalid;

2.5. in the Regulations on state registration (re-registration) of products of medical prescription and medical equipment approved by this resolution:

to add the paragraph of the eighth of Item 2 with words ", including results of inspection of their production on compliance to the requirements established by the Ministry of Health";

state Item 3 in the following edition:

"3. Implementation of state registration (re-registration) of products of medical prescription and medical equipment, modification of the registration file on the products of medical prescription and medical equipment which are earlier registered in the Republic of Belarus are preceded by complex of the preliminary technical works connected with carrying out:

primary examination of the documents necessary for implementation of state registration (re-registration) of products of medical prescription and medical equipment, modification of the registration file on the products of medical prescription and medical equipment which are earlier registered in the Republic of Belarus;

inspections of production of products of medical prescription and medical equipment;

sanitary and hygienic testing of these products and technology of national and foreign production;

technical testing of products of medical prescription and medical equipment of national production;

specialized examination of the documents necessary for implementation of state registration (re-registration) of products of medical prescription and medical equipment, modification of the registration file on the products of medical prescription and medical equipment which are earlier registered in the Republic of Belarus;

the clinical testing of products of medical prescription and medical equipment appointed by the Ministry of Health;

other researches.

The complex of preliminary technical works provided in part one of this Item is performed by the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further - RUP "The Center of Examinations and Testing in Health Care") in the cases and procedure determined by the Ministry of Health.

RUP "The Center of Examinations and Testing in Health Care" are provided according to the procedure, established by the legislation, record keeping and the document storage connected with state registration (re-registration) of products of medical prescription and medical equipment, modification of the registration file on the products of medical prescription and medical equipment which are earlier registered in the Republic of Belarus including acquisition, storage, registration and use of forms of registration certificates. The form of the registration certificate is the form with certain degree of protection.";

add the Provision with Item 3-1 of the following content:

"3-1. For the solution of questions of state registration (re-registration) of products of medical prescription and medical equipment, modification of the registration file on the products of medical prescription and medical equipment which are earlier registered in the Republic of Belarus, the Ministry of Health creates the commission on products of medical prescription and medical equipment.

The regulations on the commission on products of medical prescription and medical equipment affirm the Ministry of Health.";

in Item 7 of the word", provided in Item 3" shall be replaced with words "in the presence of the positive conclusion of RUP "The Center of Examinations and Testing in Health Care" about compliance of products of medical prescription and medical equipment to safety requirements, efficiency and the quality containing results of examinations, inspections, testing and other researches provided in Item 3 part one";

in part one of Item 16 of the word "Ministry of Health" shall be replaced with words "RUP "The Center of Examinations and Testing in Health Care";

in Item 26:

after paragraph two to add Item with the paragraph of the following content:

"the established fact of discrepancy of product quality of medical prescription and medical equipment to the declared quality in case of their state registration (re-registration) and (or) are received negative results of sanitary and hygienic, technical and clinical testing;";

the third and fourth to consider paragraphs respectively paragraphs the fourth and fifth;

the fifth to add the paragraph with the words "or the document resolving production, realization and use of product of medical prescription and medical equipment";

in part four of Item 29 of the word "Ministry of Health" shall be replaced with words "RUP "The Center of Examinations and Testing in Health Care";

Item 31 after words of "the decision on modification of the registration file" to add with words "after passing of complex of preliminary technical works in the presence of the positive conclusion of RUP "The Center of Examinations and Testing in Health Care" about compliance of products of medical prescription and medical equipment to safety requirements, efficiency and the quality containing results of examinations, inspections, testing and other researches provided in Item part one 3 this provision".

3. In this Provision terms and their determinations in the values established by the Law of the Republic of Belarus "About medicines" are used.

4. This resolution becomes effective since May 21, 2015, except for Item 3, of its official publication which is becoming effective later.

Prime Minister of the Republic of Belarus

A. Kobyakov

Approved by the Resolution of Council of Ministers of the Republic of Belarus of April 1, 2015 No. 254

Regulations on procedure and conditions of implementation of state registration (confirmation of state registration) of medicines

Chapter 1. General provisions

1. This Provision determines procedure and conditions of implementation of state registration (confirmation of state registration) of medicines, conditional state registration (confirmation of conditional state registration) of medicines, modification of the registration file, and also suspensions, cancellation of registration certificates.

Action of this provision does not extend on:

implementation of state registration of the medicines called in appendix 1 to the Presidential decree of the Republic of Belarus of December 31, 2019 No. 499 "About drug circulation" in the simplified procedure;

registration (registration confirmation) of medicines within the Eurasian Economic Union and other procedures connected with registration of medicines which are performed according to the international legal acts constituting the right of the Eurasian Economic Union.

2. In this Provision terms and their determinations in the values established by the Law of the Republic of Belarus "About drug circulation" are used.

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