ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of June 29, 2015 No. 416

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

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

1. Approve regulations of the state services:

1) "Issue of approval and (or) the conclusion (the allowing document) for import (export) of the medicines registered and not registered in the Republic of Kazakhstan and medical products" according to appendix 1 to this order;

2) "Issue of the conclusion about safety, quality and efficiency of medicines and medical products" according to appendix 2 to this order;

3) "Issue of permission to performing clinical trial and (or) testing pharmacological and medicines, medical products" according to appendix 3 to this order;

4) "State registration, re-registration and modification of the registration file of medicine or medical product" according to appendix 4 to this order;

5) "Issue of the decision on approval (non-confirmation) of names of original medicines" according to appendix 5 to this order;

6) "Issue of the certificate on assignment of qualification category to specialists with pharmaceutical education" according to appendix 6 to this order;

7) "Issue of the certificate on pharmaceutical product" it agrees 7 to this order.";

8) "Licensing for pharmaceutical activities" it agrees 8 to this order;

9) "Licensing for implementation of activities in the field of drug trafficking, psychotropic substances and precursors in the field of health care" it agrees 9 to this order.

2. To committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

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

2) to provide placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan;

To direct 3) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan to official publication in mass media and information system of law of Ad_let;

To provide 4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan to Department of legal service of the Ministry of health and social development of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

3. Recognize invalid the order of the Minister of Health of the Republic of Kazakhstan of May 26, 2014 as No. 282 "About approval of regulations of the state services in the field of pharmaceutical activities" (No. registered in the Register of state registration of regulatory legal acts 9537, published in information system of law of Ad_let on July 21, 2014).

4. To impose control of execution of this order on the Vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

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 and social development of the Republic of Kazakhstan of June 29, 2015 No. 416

Regulations of the state service "Issue of Approval and (or) the Conclusion (the Allowing Document) for Import (Export) of the Medicines Registered and Not Registered in the Republic of Kazakhstan and Medical Products"

Chapter 1. General provisions

1. The state service "Issue of Approval and (or) the Conclusion (the Allowing Document) for Import (Export) of the Medicines Registered and Not Registered in the Republic of Kazakhstan and Medical Products" (further - the state service) appears Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan (further - Committee) or its territorial subdivisions (further - the service provider), 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.

3. The rendered state service issue of the allowing document (the letter about the approvals/conclusions on import/export of the registered and unregistered medicines in the Republic of Kazakhstan and medical products), or the motivated answer in refusal of rendering the state service in the bases is result, of the stipulated in Item 9-1 Standard of the state service "Issue of Approval and (or) the Conclusion (the Allowing Document) for Import (Export) of the Medicines Registered and Not Registered in the Republic of Kazakhstan and Medical Products" approved by the order of the Minister of health and social development of the Republic of Kazakhstan of April 28, 2015 No. 293, registered in the Register of state registration of regulatory legal acts No. 11338 (further - the Standard).

Chapter 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 uslugopoluchatel based on the request in electronic form certified by the digital signature of uslugopoluchatel (further - the EDS) with application of documents, specified in Item 9 of the Standard.

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

1) the employee of office performs registration of the electronic request for rendering the state service which arrived through the portal. The executive in charge checks documents for availability (absence) of the bases for the motivated answer on refusal in issue the conclusion. By results of consideration of documents the executive in charge prepares and provides for the signature to the head the project about results of rendering the state service, completion date - 2 (two) working days;

2) the executive in charge draws up the conclusion or the motivated answer about refusal in issue of the conclusion in electronic form and directs to the signature to the head, completion date - 0,5 (4 hours) the working day;

3) the head signs the conclusion or the motivated answer about refusal in issue of the conclusion, completion date - 0,5 (4 hours) the working day.

When giving by uslugopoluchatel of all necessary documents:

Sending electronic request is performed from "personal account" of uslugopoluchatel. The inquiry is automatically sent to the service provider. Through the portal - in "personal account" of uslugopoluchatel the status about acceptance of request for rendering the state service with indication of the date of receipt of result of the state service is displayed.

Data of identity documents of uslugopoluchatel (for physical person), about state registration of the legal entity, about registration of uslugopoluchatel as the individual entrepreneur, the service provider receives by means of the portal from the corresponding state information systems in the form of the electronic data certified by the EDS of authorized persons of state bodies.

6. Result of the procedure (action) for rendering the state service which forms the basis for accomplishment of the following procedure (action):

1) electronic request with the entering number;

2) determination of the executive in charge;

3) determination of completeness of the submitted documents. In case of provision of incomplete document package, the direction of the motivated answer about refusal of consideration of the application;

4) draft of the allowing document on issue of the conclusion;

5) signed warrant of surrender of the conclusion;

6) draft of the conclusion electronically;

7) the electronic document (conclusion) signed by the EDS of the authorized person of the service provider.

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

7. The list of structural divisions (workers) of the service provider who participate in process of rendering the state service:

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

1) employee of office of the service provider;

2) head of the service provider;

3) executive in charge of the service provider.

8. The description of the sequence of procedures (actions) between structural divisions (workers) with indication of duration of each procedure (action):

1) Employee of office: registration of request - 0,5 (4 hours) the working day.

2) Head: determination of the executive in charge - 0,5 (4 hours) the working day;

3) executive in charge: check on availability (absence) of the bases for refusal in issue of the allowing document. By results of consideration of documents preparation and provision for the signature to project board about issue or about refusal in issue of the allowing document. Signing of permission and the direction it for execution, completion date - 1 (one) working day;

4) execution of the allowing document in electronic form or the motivated answer about refusal in issue of the allowing document and the direction for the signature to the head. Signing of result of rendering the state service, completion date - 1 (one) working day.

On the portal sending electronic request is performed from "personal account" of uslugopoluchatel. The inquiry is automatically sent to the state body addressee according to the chosen service.

In case of the address through the portal in "personal account" of uslugopoluchatel the status about acceptance of request for rendering the state service with indication of date and time of receipt of result of the state service is displayed.

The scheme of business process of rendering the state service, with indication of the term of accomplishment it is given in appendix 1 to these Regulations.

The working schedule of the portal - round the clock, except for technical breaks in connection with carrying out repair work (in case of the address of uslugopoluchatel after the termination of working hours, in days off and holidays according to the Labor code of the Republic of Kazakhstan reception of an application and issue of result of rendering the state service is performed the next working afternoon).

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