RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of April 23, 2015 No. 56

About approval of the Regulations on the commission on medicines and pharmaceutical substances and recognition No. 182 which voided resolutions of the Ministry of Health of the Republic of Belarus of October 31, 2008

Based on subitem 8.14-2 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 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360", parts two of Item 5 of the Regulations on procedure and conditions of state registration (confirmation of state registration) of medicines and pharmaceutical substances, the modification of the registration file approved by the 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 and pharmaceutical substances and modification and amendments in the resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269" The Ministry of Health of the Republic of Belarus DECIDES:

1. Approve the enclosed Regulations on the commission on medicines and pharmaceutical substances.

2. Declare invalid the resolution of the Ministry of Health of the Republic of Belarus of October 31, 2008 No. 182 "About approval of the Regulations on the commission on medicines" (The national register of legal acts of the Republic of Belarus, 2009, No. 2, 8/19908).

3. This resolution becomes effective after its official publication.

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of April 23, 2015 No. 56

Regulations on the commission on medicines and pharmaceutical substances

1. This Provision determines operating procedure of the commission on medicines and pharmaceutical substances (further - the commission).

2. In this Provision the main terms and their determinations in the values established by the Law of the Republic of Belarus of July 20, 2006 "About medicines" are used (The national register of legal acts of the Republic of Belarus, 2006, No. 122, 2/1258) and the Regulations on procedure and conditions of state registration (confirmation of state registration) of medicines and pharmaceutical substances, modification of the registration file approved by the 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 and pharmaceutical substances and modification and amendments in the resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269" (The national legal Internet portal of the Republic of Belarus, 07.04. 2015, 5/40348).

3. The commission is created by the Ministry of Health of the Republic of Belarus for the solution of questions of state registration (confirmation of state registration) of medicines, pharmaceutical substances, modification of the registration file on medicine, pharmaceutical substance which are earlier registered in the Republic of Belarus.

4. In the work the commission is guided by the basic international principles of carrying out state registration (confirmation of state registration) of medicines, pharmaceutical substances, modification of the registration file on medicine, pharmaceutical substance, the legislation of the Republic of Belarus, including this Provision.

5. Technical supply of work of the commission performs the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further - the Company).

6. The structure of the commission affirms the order of the Ministry of Health of the Republic of Belarus.

7. The commission chairman directs work of the commission, and during its absence - the vice-chairman of the commission.

Commission chairman is the deputy minister of health care of the Republic of Belarus.

8. According to the decision of the commission chairman persons having special knowledge in the field of medicines, pharmaceutical substances, persons conducting researches of medicines, pharmaceutical substances and other persons can be invited to commission session.

9. Commission:

considers the application and documents submitted by the applicant for state registration (confirmation of state registration) of medicines and pharmaceutical substances, modification of the registration file on medicine, pharmaceutical substance which are earlier registered in the Republic of Belarus (further - documents);

draws the conclusion about feasibility (inexpediency) of state registration (confirmation of state registration) of medicines and pharmaceutical substances, modification of the registration file on medicine, pharmaceutical substance which are earlier registered in the Republic of Belarus (further - the conclusion);

considers questions of suspension, renewal or cancellation of the registration certificate on medicine, pharmaceutical substance;

performs other functions, the stipulated by the legislation Republic of Belarus.

10. By consideration of documents by the commission actions, the stipulated in Article 20 Laws of the Republic of Belarus of October 28, 2008 "About bases of ministerial procedures" are performed (The national register of legal acts of the Republic of Belarus, 2008, No. 264, 2/1530).

11. The commission has the right:

make offers to the Ministry of Health of the Republic of Belarus, including concerning suspension, renewal or cancellation of the registration certificate on medicine, pharmaceutical substance;

make recommendations to the applicant on remedial action and improvement of quality of medicine, pharmaceutical substance;

make recommendations to the Company for questions of carrying out complex of the preliminary technical works connected with conducting examinations, the inspections of industrial production of medicines and pharmaceutical substances, testing and other researches, preceding state registration (confirmation of state registration) of medicines and pharmaceutical substances, modification of the registration file on medicine, pharmaceutical substance which are earlier registered in the Republic of Belarus.

12. Members of the commission shall:

to be present personally at commission sessions;

objectively and honesty to perform the functions assigned to the commission by this Provision;

observe confidentiality of information obtained in work progress of the commission;

perform other functions, the stipulated by the legislation Republic of Belarus.

13. Members of the commission have no right to represent the interests of the organizations with which consist in employment relationships or civil agreements are signed.

14. Preparation of materials for commission sessions is performed by the secretary of the commission.

15. The commission is competent to make the decision on condition of presence at its meeting at least two thirds of its numerical structure.

16. The decision of the commission is made by a simple majority vote by open voting (if other form of vote was not taken on commission session) and drawn up by the minutes of the commission. In case of equality of votes the decision for which the commission chairman voted, and in its absence - the vice-chairman of the commission is deemed accepted.

17. By results of consideration of documents by the commission the conclusion which is signed by all members of the commission is taken out.

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