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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of November 2, 2020 No. 93

About complex of the preliminary technical works preceding state registration of medicines

Based on paragraph two of subitem 8.14-1 of Item 8 and subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446, of part two of Item 3 and item 4 of the Regulations on procedure and conditions of implementation of state registration (confirmation of state registration) of medicines approved by the resolution of Council of Ministers of the Republic of Belarus of April 1, 2015 No. 254, the Ministry of Health of the Republic of Belarus DECIDES:

1. Approve the Instruction about procedure for carrying out complex of the preliminary technical works preceding state registration of medicines it (is applied).

2. No. 55 "About complex of the preliminary technical works preceding state registration of medical products" to exclude paragraph two of Item 1 of the resolution of the Ministry of Health of the Republic of Belarus of April 23, 2015.

3. This resolution becomes effective since November 20, 2020.

Deputy minister

B. N. Androsyuk

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of November 2, 2020 No. 93

The instruction about procedure for carrying out complex of the preliminary technical works preceding state registration of medicines

1. This Instruction determines procedure for carrying out by the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further, unless otherwise specified, - the Center) complex of the preliminary technical works (further, unless otherwise specified, - complex of preliminary works) connected with conducting examinations, approbations of techniques of quality control of medicine and quality control of this medicine with use of such techniques (further - approbation and quality control), other researches conducted for medicine confirmation of conformity to safety requirements, efficiency and qualities. The complex of preliminary works precedes state registration (confirmation of state registration) of medicines, conditional state registration (confirmation of conditional state registration) of medicines, modification of the registration file.

Action of this Instruction does not extend on:

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

registration (registration confirmation) of medicines within the Eurasian Economic Union and other procedures connected with registration of medicines, performed by the Ministry of Health according to the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and the international legal acts constituting the right of the Eurasian Economic Union.

2. In this Instruction terms and their determinations in the values established by the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation" are used.

3. The complex of preliminary works is carried out based on the agreements signed on accomplishment of separate work types between the Center and the applicant. Aggregate term of carrying out complex of preliminary works shall not exceed 180 calendar days. The specified term can be prolonged up to 360 calendar days by agreement of the parties.

For carrying out complex of preliminary works as the applicant the documents constituting the registration file according to the list according to appendix 1 to the Regulations on procedure and conditions of implementation of state registration (confirmation of state registration) of medicines are submitted to the Center (further - documents).

4. The complex of preliminary works includes:

4.1. primary examination of documents (further - primary examination) providing:

check of completeness and correctness of document creation;

assessment of conformity of the trade name of medicine to the criteria established by the resolution of the Ministry of Health of the Republic of Belarus of September 24, 2020 No. 78 "About the criteria shown to trade names of medicines".

Primary expertize is carried out by the expert who is the employee of the Center, based on the agreement signed between the Center and the applicant, in time, not exceeding 15 calendar days from the date of documents acceptance.

By results of primary examination the expert opinion which contains conclusions is drawn up:

about compliance (discrepancy) of the submitted documents to requirements of the legislation. In the absence of the copy of the document (certificate) confirming compliance of the industrial production of medicines to requirements of the Proper production practice issued by the Ministry of Health or the document (certificate) confirming compliance of industrial production of medicines to requirements of Rules of proper production practice of the Eurasian Economic Union issued by authorized body of state member of the Eurasian Economic Union (further - the certificate of GMP), in the expert opinion it is indicated the need of conducting inspection (pharmaceutical inspection) of industrial production of medicines for receipt of the certificate of GMP during the term established for carrying out complex of preliminary works;

about compliance (discrepancy) of the trade name of medicine to the established criteria.

The expert opinion specified in part three of this subitem within 5 working days from the date of its signing goes to the applicant in written and (or) electronic type. In the absence of the certificate of GMP the specified expert opinion also goes the Center to the Ministry of Health to the same time.

If the expert opinion specified in part three of this subitem contains conclusions about discrepancy of the submitted documents to requirements of the legislation and (or) discrepancy of the trade name of medicine to the established criteria, documents return to the applicant and the complex of preliminary works stops.

In case of positive result of primary examination documents go for specialized examination;

4.2. the specialized examination representing assessment of documents for the purpose of medicine confirmation of conformity to safety requirements, efficiency and qualities taking into account their chemical and pharmaceutical and kliniko-pharmacological features (further - specialized examination).

Specialized expertize is carried out based on the separate agreement signed between the Center and the applicant, in time, not exceeding 60 calendar days from the date of cash receipt on the settlement account of the Center.

Specialized expertize is carried out:

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