ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of July 17, 2017 No. 533

About modification and amendments in the 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 field of pharmaceutical activities"

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

1. Bring in the 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 field of pharmaceutical activities" (it is registered in the register of state registration of regulatory legal acts of the Republic of Kazakhstan for No. 11338, it is published in information system of law of Ad_let on July 16, 2015) the following changes and amendments:

7) and 8) of Item 1 to state subitems in the following edition:

"7) the standard of the state service "Issue of the Conclusion about Safety, Efficiency and Quality of Medicines, Products of Medical Appointment and Medical Equipment" 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;";

be reworded as follows appendices 7 and 8 according to appendices 1 and 2 to this order;

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, Products of Medical Appointment and Medical Equipment" approved by the specified order:

to state heading of Chapter 1 in the following edition:

"Chapter 1. General provisions";

state Items 2 and 3 in the following edition:

"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 are performed through:

1) office of the service provider;

2) web portal of "the electronic government": www.egov.kz, www.elicense.kz (further - the portal).";

to state heading of Chapter 2 in the following edition:

"Chapter 2. Procedure for rendering the state service";

state item 4 in the following edition:

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

from the moment of delivery of documents uslugopoluchatel on import/export of the registered and unregistered medicines in the Republic of Kazakhstan - 5 (five) working days;

on import/export of the registered and unregistered products of medical appointment and medical equipment in the Republic of Kazakhstan - 5 (five) working days;

the most allowed time of expectation for delivery of documents - 20 minutes;

the most allowed time of servicing - 20 minutes.".

In case of factual determination of incompleteness of the submitted documents the service provider gives the written motivated answer about the termination of consideration of the application.";

state Item 9 in the following edition:

"9. List of the documents necessary for rendering the state service in case of the address of uslugopoluchatel (or his representative by proxy):

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

1) for performing clinical trials and (or) testing:

the statement in form according to appendix 1 to this standard of the state service;

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

the copy of the order of authorized body in the field of health care on permission of performing clinical trials and (or) testing of medicines;

copies of the documents of the producer confirming quality of the medicines intended for performing clinical trials and (or) testing;

on the portal:

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 digital signature (further - the EDS) uslugopoluchatel;

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

the electronic copy of the order of authorized body in the field of health care on permission of performing clinical trials and (or) testing of medicines;

the electronic copy of the document of the producer confirming quality of the medicines intended for performing clinical trials and (or) testing;

2) for humanitarian assistance:

the statement in form according to appendix 1 to this standard of the state service;

the written confirmation about control of target non-commercial use of load 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 document, the load confirming humanitarian character to the receiver, with transfer into the state or Russian languages;

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

on the portal:

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 letter of local authorities of public administration of health care of areas, the cities of republican value and the capital or the organizations of health care having the license for medical activities about support of this humanitarian action with the obligation on control of target non-commercial use of load;

the electronic copy of the document confirming humanitarian character of load to the receiver with transfer on state or Russian;

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

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

the statement in form according to appendix 1 to this standard of the state service;

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

the letter from local executive bodies on emergency situation;

on the portal:

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 transfer into the state or Russian languages;

the electronic copy of the letter from local executive bodies on emergency situation.

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

1) for performing clinical trials and (or) testing:

the statement in form according to appendix 2 to this standard of the state service;

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

the copy of the order of authorized body in the field of health care on permission of performing clinical trials and (or) testing of medicines;

copies of the documents of the producer confirming quality of the medicines intended for performing clinical trials and (or) testing with transfer into the state or Russian languages;

on the portal:

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 transfer into the state or Russian languages;

the electronic copy of the order of authorized body in the field of health care on permission of performing clinical trials and (or) testing of medicines;

the electronic copy of the document of the producer confirming quality of the medicines intended for performing clinical trials and (or) testing with transfer into the state or Russian languages;

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:

the statement in form according to appendix 2 to this standard of the state service;

in case of lack of possibility of receipt of data on the granted licenses from GBD EL, the copy of the license for occupation 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 by the organizations of health care (in case of import of medicines by the organization of health care);

the letter 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 with reasons and calculations of amount of medicines;

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

the copy of the document of the producer confirming quality of medicine with transfer into the state or Russian languages;

on the portal:

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 ate, the electronic copy of the license for occupation 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 by the organizations of health care (in case of import of medicines by the organization of health care);

the electronic copy of the letter 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 with reasons and calculations of amount of medicines;

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

the electronic copy of the document of the producer confirming quality of medicine with transfer into the state or Russian languages;

3) for prevention and/or elimination of effects of emergency situations:

the statement in form according to appendix 2 to this standard of the state service;

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

the letter from local executive bodies on emergency situation;

on the portal:

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 transfer into the state or Russian languages;

the electronic copy of the letter from local executive bodies on emergency situation;

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;

the written confirmation about control of target non-commercial use of load 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 document confirming humanitarian character of load to the receiver with transfer into the state or Russian languages;

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

the document confirming quality of the imported medicines with transfer into the state or Russian languages;

on the portal:

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 letter of local authorities of public administration of health care of areas, the cities of republican value and the capital or the organizations of health care having the license for medical activities about support of this humanitarian action with the obligation on control of target non-commercial use of load;

the electronic copy of the document confirming humanitarian character of load to the receiver with transfer into the state or Russian languages;

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

the electronic copy of the document confirming quality of the imported medicines with transfer on state or Russian;

5) for implementation of innovative medical technologies:

the statement in form according to appendix 2 to this standard of the state service;

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

the written confirmation of authorized body in the field of health care about need of import of medicines for implementation of innovative medical technologies;

copies of the documents of the producer confirming quality of the medicines intended for implementation of innovative medical technologies with transfer into the state or Russian languages;

on the portal:

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 transfer into the state or Russian languages;

the electronic copy of the letter of authorized body in the field of health care about need of import of medicines for implementation of innovative medical technologies with indication of the organization of health care performing implementation of innovative medical technologies;

the electronic copy of the document of the producer confirming quality of the medicines intended for implementation of innovative medical technologies with transfer into the state or Russian languages.

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

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;

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 calculation of 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 field of drug circulation, products of medical appointment, medical equipment;

the copy of invoice (delivery note) with transfer into the state or Russian languages;

on the portal:

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 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 field of drug circulation, products of medical appointment, medical equipment;

the electronic copy of invoice (delivery note) with transfer into the state 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;

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

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

on the portal:

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;

electronic copy of the letter of confirmation of the organizer of exhibition on participation of the applicant in exhibition;

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

3) for import of the unregistered medicinal substances made in the conditions of proper production practice:

the statement in form according to appendix 2 to this standard of the state service;

in case of lack of possibility of receipt of data on the granted licenses from GBD ate, the copy of the license for occupation with pharmaceutical activities with appendix on subspecies of the activities connected with production of medicines or wholesale of medicines or the copy of the license for implementation of medical activities;

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