I.O'S ORDER. MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 20, 2014 No. 270

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

According to the subitem 2) article 10 of the Law of the Republic of Kazakhstan of April 15, 2013 "About the state services", PRIKAZYVAYU:

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

2. Declare invalid the 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" (it is registered in the Register of state registration of regulatory legal acts at No. 8117, it is published on January 12, 2013 in the Kazakhstanskaya Pravda newspaper).

3. To department of science and human resources of the Ministry of Health of the Republic of Kazakhstan (Syzdykova A. A.) provide in the procedure established by the legislation:

1) state registration of this order;

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan;

3) official publication of this order in mass media after its state registration.

4. I reserve control of execution of this order.

5. This order becomes effective after ten calendar days after day of its first official publication.

Approved by the Order of the deputy. The Minister of Health of the Republic of Kazakhstan of May 20, 2014 No. 270

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

1. General provisions

1. The state service "Issue of Permission to Performing Clinical Trials of Medical Technologies" (further - the state service) appears the Ministry of Health of the Republic of Kazakhstan (further - the Service provider) according to the standard of the state service "Issue of Permission to Performing Clinical Trials of Medical Technologies" approved by the order of the Government of the Republic of Kazakhstan of February 24, 2014 No. 141 (further - the standard).

3. Result of rendering the state service - permission to performing clinical trials of medical technologies, or the motivated answer about refusal in the state service.

2. The description of operations procedure of structural divisions (workers) of the service provider in the course of rendering the state service

4. The basis for the procedure (action) for rendering the state service is representation by uslugopoluchatel to the service provider of document package according to Item 9 of the standard submitted to the service provider on paper.

5. Contents of each procedure (action), being part of process of rendering the state service, accomplishment duration:

1) documents acceptance for rendering the state service - 15 min.;

2) registration of a statement in the magazine of registration of incoming correspondence and transfer to the head of Department of science and human resources - 15-20 minutes;

3) distribution of the arrived documents and imposing of the resolution by the head of Department of science and human resources-1-3 hours;

4) check by the executive in charge of completeness of document package - 30 minutes;

5) preparation of the motivated answer about refusal in permission of performing clinical trial, signing of the official answer by the head of Department of science and human resources - 1 working day;

6) registration of office of the letter of response by the employee in the magazine of registration of outgoing correspondence and sending to the applicant's address - up to 15-20 minutes;

7) conducting examination of materials of the request for performing clinical trials by members of the Academic council - up to 21 calendar days;

8) discussion of results of examination of materials of the request for performing clinical trials at meeting of the Academic council and decision making - till 2 o'clock;

9) issue by the service provider to uslugopoluchatel of permission to performing clinical trials purposely - 10-15 minutes.

3. The description of order of interaction of structural divisions (workers) of the service provider in the course of rendering the state service

6. In the course of rendering the state service the following structural divisions of the service provider participate:

1) management of ensuring control and document flow;

2) department of science and human resources;

3) the Academic council of the Ministry of Health of the Republic of Kazakhstan (further - the Academic council).

7. The description of the sequence of procedures (actions) between structural divisions (workers) of the service provider:

1) process 1 - documents acceptance for rendering the state service, provided by uslugopoluchatel (or his representative by proxy) in offices of the Ministry of Health of the Republic of Kazakhstan, term - 15 minutes;

2) process 2 - registration of office of documents by the employee in the magazine of registration of incoming correspondence and document transfer to the head of the service provider, term - 15-20 minutes;

3) process 3 - distribution of the arrived documents and imposing of the resolution by the head of the service provider, term-1-3 hours;

4) process 4 - check by the executive in charge of completeness of document package, term of-30 minutes;

5) condition 1 - incompleteness and (or) discrepancy of the submitted documents to the established requirements;

6) process 5 - registration of office of the letter of response by the employee in the magazine of registration of outgoing correspondence and sending to the applicant's address, term - 15-20 minutes;

7) condition 2 - in case of completeness and compliance of the submitted documents to the established requirements the executive in charge directs the electronic version of materials of the request for performing the clinical trials specified in Item 5 of these regulations of the state service, to members of the Academic council;

8) process 6 - conducting examination of materials of the request for performing clinical trials by members of the Academic council, term - up to 21 calendar days;

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