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 Item 1 of Article 251 and Item 1 of article 255 of the Code of the Republic of Kazakhstan "About health of the people and health care system", the subitem 1) of article 10 of the Law of the Republic of Kazakhstan "About the state services" 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 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 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.

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 of the Registered and Unregistered Medicines 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 of the Registered and Unregistered Medicines 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 "About health of the people and health care system" (further – the Code), the subitem 1) of article 10 of the Law of the Republic of Kazakhstan "About the state services" and determine procedure for 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 of the Registered and Unregistered Medicines in the Republic of Kazakhstan and Medical Products" (further – the state service).

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) state body in the field of drug circulation and medical products – the state body performing management in the field of drug circulation and medical products, control of drug circulation and medical products;

2) 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 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 of the Registered and Unregistered Medicines in the Republic of Kazakhstan and Medical Products"

4. For receipt of approval and (or) the conclusion (the allowing document) for import of the medicines registered in the territory of the Republic of Kazakhstan (from the countries of the Eurasian Economic Union) physical persons and legal entities (further – uslugopoluchatel) send to state body in the field of drug circulation and medical products (further – the service provider) through the web portal of "the electronic government" www.egov.kz, www.elicense.kz (further – the Portal) the statement on import of the medicines registered in the territory of the Republic of Kazakhstan (from the countries of the Eurasian Economic Union) in form according to appendix 1 to these rules, calculations of the imported amount of the registered medicines for form according to appendix 2 to these rules, the documents and data specified in Item 9 of appendix 3 to these rules:

1) for the humanitarian assistance (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 of the medicines unregistered in the territory of the Republic of Kazakhstan from the countries of the Eurasian Economic Union the uslugopoluchatel sends through the Portal to the service provider the documents and data specified in Item 9 of appendix 3 to these rules, the statement import of the medicines unregistered in the territory of the Republic of Kazakhstan from the countries of the Eurasian Economic Union in form according to appendix 4 to these rules, calculations of the imported amount of the unregistered medicines for form according to appendix 5 to these rules:

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 the humanitarian assistance (assistance);

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 and medical products within long-term agreements of supply of medicines and medical products;

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

7) for examination of medicines in case of state registration, re-registration and modification of the registration file;

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

9) for performing clinical trials.

6. For receipt of approval and (or) the conclusion (the allowing document) for import of the medical products unregistered in the territory of the Republic of Kazakhstan the uslugopoluchatel sends through the Portal to the service provider the documents and data specified in Item 9 of appendix 3 to these rules, the statement import of the medical products unregistered in the territory of the Republic of Kazakhstan in form according to appendix 6 to these rules, calculations of the imported quantity of the unregistered medical products for form according to appendix 7 to these rules:

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 the humanitarian assistance (assistance);

4) for implementation of innovative medical technologies;

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

6) for examination of medical products in case of state registration, re-registration and modification of the registration file;

7) for holding exhibitions of medical products without the right of their further realization;

8) for use as the component part which is part or devices of medical product and is not intended for independent use out of structure or the device of medical product;

9) for performing clinical trials.

7. For receipt of approval and (or) the conclusion (the allowing document) for import of the medical products registered in the territory of the Republic of Kazakhstan uslugopoluchatel sends through the Portal to the service provider the documents and data specified in Item 9 of appendix 3 to these rules, the statement import of the medical products registered in the territory of the Republic of Kazakhstan in form according to appendix 8 to these rules, calculations of the imported quantity of the registered medical products for form according to appendix 9 to these rules:

1) for the humanitarian assistance (assistance);

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

8. For receipt of approval and (or) the conclusion (the allowing document) for import of medicines to the territory of the Republic of Kazakhstan from the states which are not state members of the Eurasian Economic Union, the uslugopoluchatel sends through the Portal to the service provider the documents and data specified in Item 9 of appendix 3 to these rules, calculations of the imported amount of medicines for form according to appendix 5 to these rules, the statement import of medicines to the territory of the Republic of Kazakhstan from the states which are not state members of the Eurasian Economic Union according to appendix 10 to these rules:

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 the humanitarian assistance (assistance);

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 examination of medicines in case of state registration, re-registration and modification of the registration file.

9. The list of the main requirements to rendering the state service including form, content and result of rendering and also data taking into account features of provision of the state service is provided in the List according to appendix 3 to these rules.

When giving the uslugopoluchatel of all necessary documents through the portal in "personal account" of uslugopoluchatel displays the status about acceptance of request for rendering the state service with indication of the date of receipt of result of the state service.

10. The term of consideration of documents and issue of approval and (or) the conclusion (the allowing document) for import to the territory of the Republic of Kazakhstan of the registered and unregistered medicines, and medical products constitutes 3 (three) working days from the moment of filing of application.

11. The service provider within 2 (two) working days from the moment of document registration checks completeness of the submitted documents and (or) data.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info