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.

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 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;

3) 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;

4) 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):

1) for humanitarian assistance:

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 in the form of the electronic document signed by the EDS of uslugopoluchatel;

calculations of the imported amount of the registered medicines for form according to appendix 2 to these rules;

the electronic copy of the written confirmation about control of target non-commercial use of medicines from local authorities of public administration by health care of areas, cities of republican value and the capital (when importing medicines for the subordinated organization or the private medical organizations located in the territory of the respective region) or letters of the organization of health care of other departments supporting this humanitarian action, with indication of the name, quantity and producer of the registered medicines.

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

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 in the form of the electronic document signed by the EDS of uslugopoluchatel;

calculations of the imported amount of the registered medicines for form according to appendix 2 to these rules;

the electronic copy of the agreement (contract) or invoice (delivery note) with transfer into the Kazakh or Russian languages;

the electronic copy of the letter from local state body health care of areas, cities of republican value and the capital (when importing medicines for the subordinated organization or the private medical organizations located in the territory of the respective region) or letters of the organization of health care subordinated to local executive body or the organization of health care of other departments on prevention and (or) elimination of effects of emergency situations (natural and technogenic nature) with indication of the name, quantity and producer of the registered medicines;

the electronic copy of the warranty obligation of uslugopoluchatel about sticker attachment on packaging and instructions on medical application in the Kazakh and Russian languages.

Documents are processed and EDSs according to the List of the main requirements to 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 List) according to appendix 3 to these rules are certified.

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:

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:

the statement on 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 in the form of the electronic document signed by the EDS of uslugopoluchatel;

calculations of the imported amount of the unregistered medicines for form according to appendix 5 to these rules;

the electronic copy of the letter of approval from local authorities of public administration by health care of areas, cities of republican value and the capital, when importing medicines for the subordinated organization or the private medical organizations located in the territory of the respective region (in the presence in the state register of medicines and medical products of the registered medicines with the similar international non-proprietary name, dosage, concentration, amount and packing it is necessary to attach letters from producers or the holder of the registration certificate of their representatives about impossibility of import) or the letter of the organization of health care of other departments with reasons for use of the unregistered medicines (in the presence in the state register of medicines and medical products of the registered medicines with similar the international non-proprietary name, dosage, concentration, in amount and packing it is necessary to attach letters from producers or the holder of the registration certificate of their representatives about impossibility of import) according to the protocol of treatment with indication of rare and especially serious illness, the number of patients.

When importing immunobiological medicine for prevention of infectious diseases – the electronic copy of the letter approval from state body in the field of sanitary and epidemiologic wellbeing of the population or its territorial subdivisions with reasons for use of the unregistered immunobiological medicine in the Republic of Kazakhstan with indication of necessary amount of medicines:

approvals and (or) the conclusions of consultation of doctors of the organization of health care about inefficiency or impossibility of application for the specific patient of other registered medicines and according to the clinical protocol;

the electronic copy of the agreement (contract) or invoice (delivery note) with transfer into the Kazakh or Russian languages;

the electronic copy of the document of the producer confirming quality of medicine with transfer into the Kazakh and Russian languages (certificates of the analysis or the test report, or the quality certificate with quality evaluation indicators);

the electronic copy of the warranty obligation of uslugopoluchatel about sticker attachment on packaging and instructions on medical application in the Kazakh and Russian languages;

availability of the certificate of GMP producer;

the document confirming registration in the country of the producer (the certificate for export, the certificate of free sale, registration certificates);

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

the statement on 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 in the form of the electronic document signed by the EDS of uslugopoluchatel;

calculations of the imported amount of the unregistered medicines for form according to appendix 5 to these rules;

the electronic copy of the agreement (contract) or invoice (delivery note) with transfer into the Kazakh and Russian languages;

the electronic copy of the letter from local authorities of public administration by health care of areas, cities of republican value and the capital, when importing medicines for the subordinated organization or the private medical organizations located in the territory of the respective region (in the presence in the state register of medicines and medical products of the registered medicines with the similar international non-proprietary name, dosage, concentration, amount and packing it is necessary to attach letters from producers or the holder of the registration certificate of their representatives about impossibility of import) or the letter of the organization of health care of other departments (in the presence in the state register of medicines and medical products of the registered medicines with the similar international non-proprietary name, dosage, concentration, in amount and packing it is necessary to attach letters from producers or the holder of the registration certificate of their representatives about impossibility of import) or the organizations of health care of other departments about prevention and (or) elimination of effects of emergency situations (natural and technogenic nature) with indication of the name, quantity and producer of the unregistered medicines (in the presence in the state register of medicines and medical products of the registered medicines with the similar international non-proprietary name, dosage, concentration, amount and packing it is necessary to attach letters from producers or their representatives about impossibility of import);

the electronic copy of the document of the producer confirming quality of medicine with transfer into the Kazakh and Russian languages (certificates of the analysis or the test report, or the quality certificate with quality evaluation indicators);

the electronic copy of the warranty obligation of uslugopoluchatel about sticker attachment on packaging and instructions on medical application in the Kazakh and Russian languages;

availability of the certificate of GMP producer;

the document confirming registration in the country of the producer (the certificate for export, the certificate of free sale, registration certificates);

3) for humanitarian assistance in the cases determined by the order of the Government of the Republic of Kazakhstan of October 14, 2020 No. 662 "About determination of cases of import to the territory of the Republic of Kazakhstan of the medicines and medical products as the humanitarian assistance which did not undergo state registration in the Republic of Kazakhstan" (further – the resolution No. 662):

the statement on 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 in the form of the electronic document signed by the EDS of uslugopoluchatel;

calculations of the imported amount of the unregistered medicines for form according to appendix 5 to these rules;

the electronic acknowledgment copy about control of target non-commercial use of medicines from bodies of local public administration by health care of areas, cities of republican value and the capital (when importing medicines for the subordinated organization or the private medical organizations located in the territory of the respective region) or letters of the organization of health care of other departments supporting this humanitarian action with indication of the name, quantity and producer of the unregistered medicines;

the electronic copy of the document of the producer confirming quality of medicines with transfer into the Kazakh and Russian languages (certificates of the analysis or the test report, or the quality certificate with quality evaluation indicators);

availability of the certificate of GMP producer;

the document confirming registration in the country of the producer (the certificate for export, the certificate of free sale, registration certificates);

4) for implementation of innovative medical technologies:

the statement on 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 in the form of the electronic document signed by the EDS of uslugopoluchatel;

calculations of the imported amount of the unregistered medicines for form according to appendix 5 to these rules;

the electronic copy of the agreement (contract) or invoice (delivery note), with transfer into the Kazakh or Russian languages;

the electronic acknowledgment copy of authorized body about need of import of medicines for implementation of innovative medical technologies, with indication of the name, quantity and producer of the unregistered medicines;

electronic copies of the documents of the producer confirming quality of the medicines intended for implementation of innovative medical technologies with transfer into the Kazakh and Russian languages (certificates of the analysis or the test report, or the quality certificate with quality evaluation indicators);

the electronic copy of the warranty obligation of uslugopoluchatel about sticker attachment on packaging and instructions on medical application in the Kazakh and Russian languages;

availability of the certificate of GMP producer;

the document confirming registration in the country of the producer (the certificate for export, the certificate of free sale, registration certificates);

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:

the statement on 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 in the form of the electronic document signed by the EDS of uslugopoluchatel;

calculations of the imported amount of the unregistered medicines for form according to appendix 5 to these rules;

electronic copies of requests of the medical organizations of health care having the license for medical activities or from local authorities of public administration by health care of areas, cities of republican value and the capital;

the electronic copy of the agreement (contract) or invoice (delivery note), with transfer into the Kazakh or Russian languages;

the electronic copy of the document of the producer confirming quality of medicine with transfer into the Kazakh and Russian languages (certificates of the analysis or the test report, or the quality certificate with quality evaluation indicators);

the electronic copy of the warranty obligation of uslugopoluchatel about sticker attachment on packaging and instructions on medical application in the Kazakh and Russian languages;

availability of the certificate of GMP producer;

the document confirming registration in the country of the producer (the certificate for export, the certificate of free sale, registration certificates).

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

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