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

of April 28, 2015 No. 293

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

(as amended on 06-05-2019)

According to the subitem 1) article 10 of the Law of the Republic of Kazakhstan of April 15, 2013 "About the state services" PRIKAZYVAYU:

1. Approve:

1) the standard of the state service "Issue of Coordination 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) the standard of the state service "Licensing for Pharmaceutical Activities" according to appendix 2 to this order;

3) the standard of the state service "Licensing for Implementation of Activities in the Sphere of Drug Trafficking, Psychotropic Substances and Precursors in the field of Health Care" according to appendix 3 to this order;

4) the standard of the state service "Issue of the Decision on Approval (Non-confirmation) of Names of Original Medicines" according to appendix 4 to this order;

5) the standard of the state service "Issue of Permission to Performing Clinical Trial and (or) Testing Pharmacological and Medicines, Medical Products" according to appendix 5 to this order;

6) the standard of the state service "State Registration, Re-registration and Modification of the Registration File of Medicine or Medical Product" according to appendix 6 to this order;

7) the standard of the state service "Issue of the Conclusion about Safety, Quality and Efficiency of Medicines and Medical Products" according to appendix 7 to this order;

8) the standard of the state service "Issue of the Certificate on Pharmaceutical Product" according to appendix 8 to this order;

9) the standard of the state service "Issue of the Certificate on Assignment of Qualification Category to Specialists with Pharmaceutical Education" according to appendix 9 to this order.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan in the procedure established by the legislation:

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

2) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan.

3. 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.

4. This order becomes effective after ten calendar days after day of its first official publication.

Minister of health and social development of the Republic of Kazakhstan

T. Duysenova

It is approved

Minister of investments and development of the Republic of Kazakhstan

14 May, 2015

 

____________________ A. Isekeshev

It is approved

Minister of national economy of the Republic of Kazakhstan

8 May, 2015

 

__________________ E.Dosayev

Appendix 1

to the Order of the Minister of health and social development of the Republic of Kazakhstan of April 28, 2015 No. 293

Standard of the state service "Issue of Coordination 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 Coordination 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).

2. The standard of the state service is developed by the Ministry of Health of the Republic of Kazakhstan (further - the Ministry).

3. The state service appears Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan (further - Committee) and its territorial departments (further - the service provider).

Reception of an application and issue of result of rendering the state service is performed through the web portal of "the electronic government": www.egov.kz, www.elicense.kz (further - the portal).

Chapter 2. Procedure for rendering the state service

4. Terms of rendering the state service by Committee and territorial departments:

on import/export of the registered and unregistered medicines in the Republic of Kazakhstan - 3 (three) working days;

on import/export of the registered and unregistered medical products in the Republic of Kazakhstan - 3 (three) working days.

Day of giving of document package to the service provider through the portal does not enter rendering state service in time.

5. Form of rendering the state service: electronic.

6. Result of rendering the state service - the coordination / conclusion (the allowing document) for import/export of the registered and unregistered medicines in the Republic of Kazakhstan and medical products, or the motivated answer about refusal in rendering the state service in the bases, the stipulated in Item 9-1 this standard.

Form of provision of result of rendering the state service: electronic.

7. The state service is rendered free of charge to physical persons and legal entities (further - uslugopoluchatel).

8. 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).

9. The list of the documents necessary for rendering the state service in case of the address of uslugopoluchatel (or his representative by proxy) on the portal:

For import of the registered medicines uslugopoluchatel submit on the portal to Committee the following documents:

1) for humanitarian assistance:

the statement in form according to appendix 1 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

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 the areas, cities of republican value and the capital or the organizations of health care having the license for medical activities, supporting this humanitarian action;

the electronic copy of the document confirming humanitarian character of freight with the translation into the Kazakh or Russian languages;

electronic copy of the plan of target use (distribution) of the humanitarian assistance;

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

the statement in form according to appendix 1 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

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

the electronic copy of the letter from local executive bodies on emergency situation (natural and technogenic nature).

For import of medicines, unregistered in the territory of the Republic of Kazakhstan, uslugopoluchatel submit on the portal to Committee the following documents:

1) for performing clinical trials:

the statement in form according to appendix 2 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

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

the electronic copy of the order of authorized body on permission of performing clinical trials of medicines;

electronic copies of the documents of the producer confirming quality of medicine with the translation into the Kazakh or Russian languages (certificates of the analysis or certificates on pharmaceutical product of SRR);

2) 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 in form according to appendix 2 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

in case of lack of possibility of receipt of data on the granted licenses from GBD EL, the electronic copy of the license for pharmaceutical activities with appendix on subspecies of the activities connected with wholesale of medicines or the copy of the license for implementation of medical activities (in case of import of medicines by the organization of health care);

the electronic copy of the letter of coordination from bodies of local public administration by health care of areas, cities of republican value and the capital (in case of import of 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 authorized body or the organization of health care of other departments with appendix of reasons for use of the unregistered medicines (in case of availability in the market of the registered medicines with appendix of letters from producers or their representatives about impossibility of import) according to the protocol of treatment with indication of rare and especially serious illness, the number of patients and calculation of the imported quantity or the electronic copy of the letter of coordination from state body in the sphere of sanitary and epidemiologic wellbeing of the population about requirement of the unregistered immunobiological medicine in the Republic of Kazakhstan with indication of necessary amount of medicine;

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

the electronic copy of the document of the producer confirming quality of medicine with the translation into the Kazakh or Russian languages (certificates of the analysis or certificates on pharmaceutical product of SRR);

3) for prevention and (or) elimination of consequences of emergency situations:

the statement in form according to appendix 2 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

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

the electronic copy of the letter from local executive bodies on emergency situation (natural and technogenic nature);

4) for humanitarian assistance in the cases determined by the Government of the Republic of Kazakhstan according to Item 23) of article 6 of the Code of the Republic of Kazakhstan "About health of the people and health care system":

the statement in form according to appendix 2 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic acknowledgment copy about control of target non-commercial use of medicines from local authorities of public administration by health care of the areas, cities of republican value and the capital or the organizations of health care having the license for medical activities, supporting this humanitarian action;

the electronic copy of the document confirming humanitarian character of freight to the receiver with the translation into the Kazakh or Russian languages;

electronic copy of the plan of target use (distribution) of the humanitarian assistance;

the electronic copy of the document of the producer confirming quality of medicines with the translation into the Kazakh or Russian languages (certificates of the analysis or certificates on pharmaceutical product of SRR);

5) for implementation of innovative medical technologies:

the statement in form according to appendix 2 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the agreement (contract) or invoice (delivery note), with the translation 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;

electronic copies of the documents of the producer confirming quality of the medicines intended for implementation of innovative medical technologies with the translation into the Kazakh or Russian languages (certificates of the analysis or certificates on pharmaceutical product of SRR);

6) 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 in form according to appendix 2 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the license for pharmaceutical activities with appendix on subspecies of the activities connected with wholesale of medicines;

electronic copies of requests of the medical organizations of health care having the license for medical activities or from bodies of local 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 the translation into the Kazakh or Russian languages;

the electronic copy of the document of the producer confirming quality of medicine with the translation into the Kazakh or Russian languages (certificates of the analysis or certificates on pharmaceutical product of SRR);

the electronic copy of the warranty obligation of the applicant about sticker attachment in packaging in the Kazakh and Russian languages (when importing limited amount of expensive orphan (rare) medicines) and instructions on medical application in the Kazakh and Russian languages.

For import of medicines, unregistered in the territory of the Republic of Kazakhstan, uslugopoluchatel submit on the portal to territorial departments the following documents:

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

the statement in form according to appendix 2 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the warranty obligation about data presentation of samples for state registration, re-registration and modification of the registration file on the territories of the Republic of Kazakhstan;

the electronic copy of calculation of necessary amount of medicines for conducting examination in case of state registration, re-registration, modification of the registration file, approved with the state expert organization in the sphere of drug circulation and medical products;

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

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

the statement in form according to appendix 2 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the comfort letter of the organizer of exhibition about participation of the applicant in exhibition;

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

For import of the medical products registered in the territory of the Republic of Kazakhstan uslugopoluchatel submit on the portal to Committee the following documents:

1) for import of the registered medical products intended for humanitarian assistance (assistance):

the statement in form according to appendix 3 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the written confirmation about control of target non-commercial use of freight from local authorities of public administration by health care of areas, the cities of republican value and the capital or the organizations of health care having the license for medical activities, supporting this humanitarian action;

the electronic copy of the document confirming humanitarian character of freight to the receiver with the translation into the Kazakh or Russian languages;

electronic copy of the plan of target use (distribution) of the humanitarian assistance;

2) for import of the registered medical products intended for prevention and/or elimination of consequences of emergency situations:

the statement in form according to appendix 3 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the agreement (contract) or invoice (delivery note), and also the translation) on the Kazakh or Russian languages;

the electronic copy of the letter from local executive bodies on emergency situation (natural and technogenic nature).

For import of medical products, unregistered in the territory of the Republic of Kazakhstan, uslugopoluchatel submit on the portal to Committee the following documents:

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 in form according to appendix 4 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

in case of lack of possibility of receipt of data on the granted licenses from GBD EL, the electronic copy of the license for occupation pharmaceutical activities with appendix on subspecies of the activities connected with wholesale of medical products or the coupon about acceptance of the notification on the beginning of activities on wholesale of the medical products or the license for implementation of medical activities by the organizations of health care (in case of import of medical products by the organization of health care) issued according to the legislation of the Republic of Kazakhstan;

the electronic copy of the letter of coordination from bodies of local public administration by health care of areas, cities of republican value and the capital (in case of import of medical products 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 authorized body or the organization of health care of other departments with appendix of reasons for application of the unregistered medical products which do not have the registered analogs of medical products and calculation of the imported quantity of medical products;

the electronic copy of the agreement (contract) or invoice (delivery note), and also the translation) on the Kazakh or Russian languages;

the electronic copy of the document of the producer confirming quality of medical products with the translation into the Kazakh or Russian languages (certificates (declarations) on compliance or certificates of the analysis);

2) for prevention and/or elimination of consequences of emergency situations:

the statement in form according to appendix 4 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the agreement (contract) or invoice (delivery note), and also the translation) on the Kazakh or Russian languages;

the electronic copy of the letter from local executive bodies on emergency situation (natural and technogenic nature);

3) for use as the accessory which is part or devices of medical product and is not intended for independent use out of structure or the device of medical product:

the statement in form according to appendix 4 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

in case of lack of possibility of receipt of data on the granted licenses from GBD EL, the electronic copy of the license for occupation pharmaceutical activities with appendix on subspecies of the activities connected with wholesale of medical products or the coupon about acceptance of the notification on the beginning of activities on wholesale of the medical products or the license for implementation of medical activities by the organizations of health care (in case of import by the organization of health care of medical product and accessories to it) issued according to the legislation of the Republic of Kazakhstan;

the electronic copy of the letter from the organization of health care, confirming the need for the accessory, being part or the device of medical product and not intended for independent use out of structure or devices of medical product;

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

the electronic copy of the conclusion of the state expert organization in the sphere of drug circulation and medical products about accessory or about lack of belonging to medical products of the imported accessories which are part of medical products, devices of medical products for picking of medical product (in case of import to the Republic of Kazakhstan the completing medical product being integral part of medical product);

4) for performing clinical trials:

the statement in form according to appendix 4 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the agreement (contract) or invoice (delivery note), and also the translation) on the Kazakh or Russian languages;

the electronic copy of the order of authorized body on permission of performing clinical trials of medical products;

the electronic copy of the documents of the producer confirming quality of the medical products intended for performing clinical trials with the translation into the Kazakh or Russian languages (certificates (declarations) on compliance or certificates of the analysis);

5) for humanitarian assistance in the cases determined by the Government of the Republic of Kazakhstan according to Item 23) of article 6 of the Code of the Republic of Kazakhstan "About health of the people and health care system":

the statement in form according to appendix 4 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the written confirmation about control of target non-commercial use of freight from local authorities of public administration by health care of areas, the cities of republican value and the capital or the organizations of health care having the license for medical activities, supporting this humanitarian action;

the electronic copy of the document confirming humanitarian character of freight to the receiver with the translation into the Kazakh or Russian languages;

electronic copy of the plan of target use (distribution) of the humanitarian assistance;

the electronic copy of the document of the producer confirming quality of medical products with the translation into the Kazakh or Russian languages (certificates (declarations) on compliance or certificates of the analysis);

6) for implementation of innovative medical technologies:

the statement in form according to appendix 4 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the agreement (contract) or invoice (delivery note), and also the translation) on the Kazakh or Russian languages;

the electronic copy of the written confirmation of authorized body about need of import of medical products for implementation of innovative medical technologies;

electronic copies of the documents of the producer confirming quality of the medical products intended for implementation of innovative medical technologies with the translation into the Kazakh or Russian languages (certificates (declarations) on compliance or certificates of the analysis);

7) 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 medical products within long-term agreements of delivery of medical products:

the statement in form according to appendix 4 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the license for pharmaceutical activities with appendix on subspecies of the activities connected with wholesale of medical products or the coupon about acceptance of the notification on the beginning of activities for wholesale of the medical products issued according to the legislation of the Republic of Kazakhstan;

electronic copies of requests of the medical organizations of health care having the license for medical activities or from bodies of local 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), and also the translation) on the Kazakh or Russian languages;

the electronic copy of the document of the producer confirming quality of medical products with the translation into the Kazakh or Russian languages (certificates (declarations) on compliance or certificates of the analysis);

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

For import of medical products, unregistered in the territory of the Republic of Kazakhstan, uslugopoluchatel submit on the portal to territorial departments the following documents:

1) when importing samples of medical products for carrying out state registration, re-registration and modification of the registration file:

the statement in form according to appendix 4 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the warranty obligation about data presentation of samples for state registration, re-registration and modification of the registration file on the territories of the Republic of Kazakhstan;

the electronic copy of calculation of quantity of medical products for conducting examination in case of state registration, re-registration, modification of the registration file, approved with the state expert organization in the sphere of drug circulation, medical products;

electronic copy of invoice (delivery note), and also translation into the Kazakh or Russian languages;

2) for holding exhibitions of medical products without the right of their further realization:

the statement in form according to appendix 4 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

the electronic copy of the written confirmation of the organizer of exhibition about participation of the applicant in exhibition;

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

Data on identity documents, on state registration as the individual entrepreneur, about state registration (re-registration) of the legal entity, about licenses on pharmaceutical and medical activities, on occupation types of activity in the sphere of drug trafficking, psychotropic substances and precursors, about acceptance of the notification on the beginning of activities on wholesale of the medical products containing in the state information systems, the service provider receives from the corresponding state information systems through lock of "the electronic government".

Uslugopoluchatel agrees to use of the data which are the secret protected by the law, containing in information systems when rendering the state services if other is not provided by the laws of the Republic of Kazakhstan.

For export of medicines and medical products uslugopoluchatel submit on the portal to territorial departments the following documents:

the statement in form according to appendix 5 to this standard of the state service in the form of the electronic document signed by the EDS of uslugopoluchatel;

in case of lack of possibility of receipt of data on the granted licenses from GBD EL, the electronic copy of the license for occupation pharmaceutical activities with appendix on subspecies of the activities connected with production of medicines and medical products or wholesale of medicines and medical products or the coupon about acceptance of the notification on the beginning of activities on wholesale of the medical products or the license for implementation of medical activities (in case of export of medicines and medical products by the organization of health care) issued according to the legislation of the Republic of Kazakhstan.

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