ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 26, 2014 No. 282

About approval of regulations of the state services in the sphere of pharmaceutical activities

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 regulations of the state services:

1) "Coordination of import/export of the registered and unregistered medicines in the Republic of Kazakhstan, products of medical appointment and medical equipment" according to appendix 1 to this order;

2) "Certification of specialists with medical education for implementation of realization of medicines, products of medical appointment in settlements, remote from the district center, through pharmaceutical Items in the organizations of health care giving primary medical and sanitary, consulting and diagnostic help, and mobile pharmaceutical units in case of absence of the specialist with pharmaceutical education" according to appendix 2 to this order;

3) "Issue of permission to advertizing of medicines, products of medical appointment and medical equipment" according to appendix 3 to this order;

4) "Issue of permission to carrying out preclinical (not clinical) researches of biologically active agents" according to appendix 4 to this order;

5) "Issue of permission to performing clinical trials and (or) testing pharmacological and medicines, products of medical appointment and medical equipment" according to appendix 5 to this order;

6) "State registration, re-registration and modification of the registration file of medicines, products of medical appointment and medical equipment" according to appendix 6 to this order.

2. To committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan (Akhmetniyazova L.M.):

1) to provide state registration of this order in the Ministry of Justice of the Republic of Kazakhstan and its subsequent publication in official mass media in the procedure established by the legislation;

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

3. Recognize invalid some orders of the Minister of Health of the Republic of Kazakhstan according to appendix 7 to this order.

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 after ten calendar days from the date of its first official publication.

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of May 26, 2014 No. 282

Regulations of the state service "Coordination of Import/export of the Medicines Registered and Not Registered in the Republic of Kazakhstan, Products of Medical Appointment and Medical Equipment"

1. General provisions

1. The state service "Coordination of Import/export of the Medicines Registered and Not Registered in the Republic of Kazakhstan, Products of Medical Appointment and Medical Equipment" (further - the state service) appears Committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan (further - Committee) or its territorial subdivisions (further - the service provider), including through the web portal of "the electronic government": www.egov.kz or E-litsenzirovaniye web portal: www.elicense.kz.

2. Form of rendering the state service: electronic (partially automated) and (or) paper.

3. Issue of the allowing document (the letter about the coordination / conclusions on import/export of the registered and unregistered medicines in the Republic of Kazakhstan, products of medical appointment and medical equipment) on paper is result of the rendered 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 state service is rendered to physical persons and legal entities (further - uslugopoluchatel) based on the statement and the documents filed to the service provider according to Item 9 of the Standard of the state service "Coordination of Import/export of the Registered and Unregistered Medicines in the Republic of Kazakhstan, Products of Medical Appointment and Medical Equipment" approved by the order of the Government of February 24, 2014 No. 142 (further - the standard).

5. The description of the sequence of procedures (actions) between structural divisions (workers):

1) the uslugopoluchatel submits the application and necessary documents according to the order of the Government of the Republic of Kazakhstan of May 31, 2012 No. 711 (further - RK software) through office of the service provider or electronically through the portal on condition of availability of the digital signature;

2) the employee of office within one working day carries out registration of a statement from the date of receipt of the document and reports to management for further vising;

3) the document with the visa of management within one working day goes to the executive in charge for further work;

4) the executive in charge checks within two working days from the date of receipt of the document of the applicant completeness of the submitted documents;

5) the executive in charge within three working days prepares the allowing document for import/export of the registered and unregistered medicines in the Republic of Kazakhstan;

6) the executive in charge within one working day prepares the allowing document for import/export of products of medical appointment and medical equipment;

6. The employee of office issues to uslugopoluchatel the allowing document according to RK software;

the most allowed time of expectation for delivery of documents - 20 minutes;

the most allowed time of servicing in case of adoption of documents - 20 minutes;

in case of the address on the portal:

the term of consideration of the application on the state service constitutes 3 (three) working days.

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