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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of December 8, 2020 No. KR DSM-237/2020

About approval of Rules of import to the territory of the Republic of Kazakhstan and export from the territory of the Republic of Kazakhstan of medicines and medical products and rendering 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"

According to the subitem 1) of article 10 of the Law of the Republic of Kazakhstan of April 15, 2013 "About the state services", Item 1 of Article 251 and Item 1 of article 255 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" I ORDER:

1. Approve:

1) Rules of import to the territory of the Republic of Kazakhstan of medicines and medical products and rendering 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" according to appendix 1 to this order;

2) Rules of export from the territory of the Republic of Kazakhstan of medicines and medical products and rendering 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" according to appendix 2 to this order.".

2. Recognize invalid some orders according to appendix 3 to this order.

3. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

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

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

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

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

Minister of Health of the Republic of Kazakhstan

A. Tsoi

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of December 8, 2020 No. KR DSM-237/2020

Rules of import to the territory of the Republic of Kazakhstan of medicines and medical products and rendering 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. These rules of import to the territory of the Republic of Kazakhstan of medicines and medical products and rendering 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 - Rules) are developed according to Item 1 of article 251 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further - the Code) and determine procedure for import of medicines and medical products to the Republic of Kazakhstan and rendering 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".

2. Import of medicines from the states which are not state members of the Eurasian Economic Union is performed according to the Regulations on import to customs area of the Eurasian Economic Union of medicines approved by the decision of Board of the Eurasian economic commission of April 21, 2015 No. 30.

3. In these rules the following basic concepts are used:

1) authorized body in the field of health care (further - authorized body) - the central executive body performing management and cross-industry coordination in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, control of quality of medical services;

2) the standard of the state service - the list of the main requirements to rendering the state service including characteristics of process, form, content and result of rendering, and also other data taking into account features of provision of the state service;

3) proper production practice (GMP) - the standard in the field of health care establishing requirements to production organization, production process and monitoring procedure in case of production of medicines, medical products;

4) the registration file - the set of documents and materials of the established content represented together with the statement on state registration, re-registration of medicine, medical products and modification of the registration file;

5) the web portal of "the electronic government" - the information system representing single window of access to all consolidated government information including the regulatory legal base, and to the state services, services in issue of specifications on connection to the networks of subjects of natural monopolies and services of subjects of the quasi-public sector rendered electronically;

6) the digital signature (further - the EDS) - set of electronic digital symbols created by means of the digital signature and confirming reliability of the electronic document, its accessory and invariance of content.

Chapter 2. Procedure for import of medicines and medical products and rendering 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"

4. For receipt of approval and (or) the conclusion (the allowing document) for import to the territory of the Republic of Kazakhstan of the medicines registered in the Republic of Kazakhstan the applicant sends to Committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan (further - the service provider) the statement in form according to appendix 1 to these rules, with application of documents specified in the 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" (further - the Standard) according to appendix 2 to these rules, certified by the digital signature (further - the EDS), through the web portal of "the electronic government" www.egov.kz, www.elicense.kz (further - the Portal):

1) for humanitarian assistance;

2) for prevention and (or) elimination of effects of emergency situations;

5. For receipt of approval and (or) the conclusion (the allowing document) for import to the territory of the Republic of Kazakhstan of the unregistered medicines applicants submit the application in form according to appendix 3 to these rules and the documents specified in the Standard according to appendix 2 to these rules certified by the EDS, on the Portal in territorial department of Committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan (further - territorial departments):

1) when importing samples of medicines for conducting examination, state registration, re-registration and modification of the registration file;

2) for holding exhibitions of medicines without the right of their further realization;

3) for performing clinical trials.

6. For receipt of approval and (or) the conclusion (the allowing document) for import to the territory of the Republic of Kazakhstan of the unregistered medicines in the Republic of Kazakhstan the applicant submits the application in form according to appendix 3 to these rules and calculation for form according to appendix 4 to these rules with application of documents specified in the Standard according to appendix 2 to these rules, the medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan certified by the EDS on the Portal in Committee (further - Committee):

1) for delivery of health care according to vital testimonies of the specific patient or delivery of health care to the narrow contingent of patients with rare and (or) especially heavy pathology with possibility of medical application and purchase;

2) for prevention and (or) elimination of effects of emergency situations;

3) for humanitarian assistance in the cases determined by the Government of the Republic of Kazakhstan according to Item 5) of article 6 of the Code of the Republic of Kazakhstan "About health of the people and health care system";

4) for implementation of innovative medical technologies;

5) for purchase by the single distributor of the medicines delivered by the international organizations founded by the General Assembly of the United Nations, and (or) prekvalifitsirovanny the World Health Organization, except for medicines within long-term agreements of supply of medicines;

6) for prevention and treatment of effects of impact radioactive, biological and chemicals (vaccines, antidote).

7. For receipt of approval and (or) the conclusion (the allowing document) for import to the territory of the Republic of Kazakhstan of medical products, unregistered in the territory of the Republic of Kazakhstan, applicants submit the application in form according to appendix 5 and calculation for form according to appendix 6 to these rules with application of documents specified in the Standard according to appendix 2 to these rules, certified by the EDS on the portal in Committee:

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