ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 5, 2012 No. 767

About approval of regulations of the state service "Issue of Permission to Performing Clinical Trials of Medical Technologies"

According to Article 34 of the Budget code of the Republic of Kazakhstan and article 9-1 of the Law of the Republic of Kazakhstan of November 27, 2000 "About ministerial procedures", PRIKAZYVAYU:

1. Approve the enclosed regulations of the state service "Issue of Permission to Performing Clinical Trials of Medical Technologies".

2. To department of science and human resources of the Ministry of Health of the Republic of Kazakhstan (Teleuov M. K.):

1) to provide state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) after state registration of this order to provide its placement on Internet resource of the Ministry of Health of the Republic of Kazakhstan.

3. To department of legal service of the Ministry of Health of the Republic of Kazakhstan (Danayeva Zh. Zh.) provide official publication of this order in mass media after its state registration in the Ministry of Justice of the Republic of Kazakhstan.

4. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Bayzhunusov E. A.

5. This order becomes effective from the date of its first official publication.

 

Approved by the order of the Minister of Health of the Republic of Kazakhstan of November 5, 2012, No. 767

Regulations of the state service "Issue of Permission to Performing Clinical Trials of Medical Technologies"

1. General provisions

1. These Regulations of the state service "Issue of Permission to Performing Clinical Trials of Medical Technologies" (further - regulations) are developed according to item 4 of article 9-1 of the Law of the Republic of Kazakhstan of November 27, 2000 "About ministerial procedures".

2. The state service "Issue of Permission to Performing Clinical Trials of Medical Technologies" (further - the state service) is provided by the Ministry of Health of the Republic of Kazakhstan (further - authorized body) on the address: city of Astana, Ulitsa Orynbor, 8, House of the Ministries, No. entrance 5, office 1142, phone of office: 8 (7172) 74-32-43.

3. In these Regulations the following determinations are used:

1) structural division - Department of science of human resources of authorized body;

2) permission - the order of the head of authorized body, on performing clinical trials of medical technologies (further - permission);

3) the employee of office - the employee of office of authorized body responsible for acceptance and document registration to the receiver of the state service;

4) the specialist - the employee of structural division of authorized body responsible for rendering the state service;

5) the receiver of the state service - the physical person or legal entity applying for receipt of permission;

6) structurally functional units - officials who participate in process of rendering the state service (further - SFE);

7) the academic council - advisory advisory body concerning development of medical and pharmaceutical science.

4. Form of the rendered state service: not automated.

5. The state service is rendered on the basis:

1) article 72 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system";

2) the standard of the state service "Issue of Permission to Performing Clinical Trials of Medical Technologies", No. 1173 approved by the Order of the Government of the Republic of Kazakhstan of September 10, 2012 (further - the standard);

3) the order of the Minister of Health of the Republic of Kazakhstan of November 12, 2009 No. 697 "About approval of Rules of carrying out medicobiological experiments, preclinical (not clinical) and clinical trials" (it is registered in the Register of state registration of regulatory legal acts at No. 5932).

2. Requirements to rendering the state service

6. Information on the location and the working schedule of authorized body, procedure and the course of rendering the state service can be received on Internet resource of www.mz.gov.kz authorized body.

7. Terms of rendering the state service are specified in Item 7 of the standard.

8. The basis for refusal in provision of the state service is representation by the receiver of the state service of false information.

9. Stages of rendering the state service:

1) documents acceptance of the receiver of the state service is performed in office of authorized body by the principle of "one window" during the working day based on the working schedule to the address: city of Astana, Ulitsa Orynbor, 8, House of the Ministries, No. entrance 5, office No. 013;

2) the employee of office from the moment of the address of the receiver of the state service:

checks availability of all submitted documents specified in the statement;

registers in the magazine of registration of addresses;

transfers documents to the head of authorized body;

3) head of authorized body:

examines contents of documents;

imposes the resolution;

sends to the structural division supervising questions of activities of the Academic council of authorized body;

4) the structural division, the Academic council performs the following functions:

considers documents and transfers the arrived documents to the executive in charge;

considers requests for performing clinical trials;

carries out expertize of the provided materials;

makes the decision on issue of permission to performing clinical trials of medical technologies;

creates materials by results of examination;

makes the draft of the order and transfers to the head of authorized body for acceptance of the final decision;

5) head of authorized body:

resolves issue of issue of permission to performing clinical trials of medical technologies or refusal in issue based on the conclusion of the Academic council;

6) executive in charge of structural division:

informs the receiver of the state service of the warrant of surrender of permission or the motivated answer about refusal.

10. Is result of rendering the state service:

issue of permission on paper;

motivated refusal on paper.

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