ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of February 24, 2014 No. 142

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

According to the subitem 3) of article 6 of the Law of the Republic of Kazakhstan of April 15, 2013 "About the state services" the Government of the Republic of Kazakhstan DECIDES:

1. Approve enclosed:

1) standard of the state service "Approval of Import/export of the Registered and Unregistered Medicines in the Republic of Kazakhstan, Products of Medical Appointment and Medical Equipment";

2) standard of the state service "Certification of Specialists with Medical Education for Implementation of Realization of Medicines, Products of Medical Appointment in Settlements, Remote from the District Center, through Pharmaceutical Items in the Organizations of Health Care Giving Primary Medical and Sanitary, Consulting and Diagnostic Help, and Mobile Pharmaceutical Units in case of Absence of the Specialist with Pharmaceutical Education";

3) standard of the state service "Issue of Licenses, Renewal, Issue of Duplicates of the License for Pharmaceutical Activities";

4) standard of the state service "Issue of Licenses, Renewal, Issue of Duplicates of the License for the Activities Connected with Drug Trafficking, Psychotropic Substances and Precursors in the field of Health Care";

5) standard of the state service "Issue of Permission to Advertising of Medicines, Products of Medical Appointment and Medical Equipment";

6) standard of the state service "Issue of Permission to Carrying Out Preclinical (Not Clinical) Researches of Biologically Active Agents";

7) standard of the state service "Issue of Permission to Performing Clinical Trials and (or) Testing Pharmacological and Medicines, Products of Medical Appointment and Medical Equipment";

8) standard of the state service "State Registration, Re-registration and Modification of the Registration File of Medicines, Products of Medical Appointment and Medical Equipment".

2. Recognize invalid some decisions of the Government of the Republic of Kazakhstan according to appendix to this resolution.

3. This resolution becomes effective after ten calendar days after day of its first official publication.

Approved by the Order of the Government of the Republic of Kazakhstan of February 24, 2014, No. 142

Standard of the state service "Approval of Import / Export of the Registered and Unregistered Medicines in the Republic of Kazakhstan, Products of Medical Appointment and Medical Equipment"

1. General provisions

1. The state service "Approval of Import/export of the Registered and Unregistered Medicines in the Republic of Kazakhstan, Products of Medical Appointment and Medical Equipment" (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 control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan (further - Committee) or its territorial subdivisions (further - the service provider), including through the web portal of "the electronic government": www.egov.kz, www.e.gov.kz or E-litsenzirovaniye web portal: www.elicense.kz.

Reception of applications and issue of results of rendering the state service are performed through:

1) the service provider by means of office or the E-litsenzirovaniye web portal: www.elicense.kz (further - the portal);

2) web portal of "the electronic government": www.egov.kz.

2. Procedure for rendering the state service

4. Terms of rendering the state service:

1) in case of the address to the service provider:

from the moment of delivery of documents uslugopoluchatel on import/export of the registered and unregistered medicines in the Republic of Kazakhstan constitutes 7 (seven) working days, products of medical appointment and medical equipment constitutes 5 (five) working days;

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

the most allowed time of servicing - 20 minutes;

2) in case of the address on the portal:

the term of consideration of the application on import/export of the registered and unregistered medicines in the Republic of Kazakhstan, products of medical appointment and medical equipment constitutes 3 (three) working days.

5. Form of rendering the state service: electronic (partially automated) and (or) paper.

6. Result of rendering the state service - the approval / conclusion (the allowing document) for import/export of the registered and unregistered medicines in the Republic of Kazakhstan, products of medical appointment and medical equipment.

7. The state service is rendered free of charge.

8. Working schedule:

1) the service provider - Monday through Friday, from 9-00 till 18-30 o'clock with lunch break from 13-00 till 14-30 o'clock, except days off and holidays, according to the labor law of the Republic of Kazakhstan.

The state service is rendered in turn, without making an appointment and the accelerated servicing;

2) the portal - round the clock (except for technical breaks in connection with carrying out repair work).

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 the uslugopoluchatel submits to the service provider (to Committee) the following documents:

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

the statement, 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;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, signed by the digital signature (further - the EDS) uslugopoluchatel;

the contract (contract) or invoice (delivery note) with transfer into the state or Russian languages - in the form of the electronic document;

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

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

2) for humanitarian assistance:

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

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 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 inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

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 - in the form of the electronic copy of the document;

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

the plan of target use (distribution) of the humanitarian assistance - in the form of the electronic document;

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

the statement, 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;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

the contract (contract) or invoice (delivery note) with transfer into the state or Russian languages - in the form of the electronic document;

the letter from local executive bodies on emergency situation - in the form of the electronic copy of the document.

In case of the address to the service provider and on the portal of the data on state registration (re-registration) as the individual entrepreneur - for physical persons, the data on state registration (re-registration) of the legal entity containing in the state information systems, the service provider receives from the corresponding state information systems in the form of the electronic documents certified by the digital signature of authorized persons of state bodies.

For review import of the medicines registered in the territory of the Republic of Kazakhstan (except for the above-stated subitems 1), of Item 9 uslugopoluchatel represent 2), 3) to the service provider (to territorial subdivisions of Committee) the following documents:

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

in case of lack of possibility of receipt of data on the granted licenses from the state database of electronic licensing (further - GBD EL), the copy of the license for occupation pharmaceutical activities with appendix on subspecies of the activities connected with production of medicines or 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 copy of the license and appendix to the license for occupation types of activity in the field of drug trafficking, psychotropic substances and precursors (in case of import of the medicines containing drugs, psychotropic substances and precursors);

the copy of the agreement (contract) with indication of regulations on realization of the imported medicines only in the territory of the Republic of Kazakhstan, and also the copy of the specification, with indication of the producer and the country of the producer and the country of the producer of medicines with transfer into the state or Russian languages;

the copy of the document from the producer or its authorized representation confirming the distributor rights of the supplier to import of medicines from the territory of the country which is not the country - producer of medicine with transfer into the state or Russian languages;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

the license for occupation pharmaceutical activities with appendix on subspecies of the activities connected with production of medicines or 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 license and appendix to the license for occupation types of activity in the field of drug trafficking, psychotropic substances and precursors (in case of import of the medicines containing drugs, psychotropic substances and precursors) - in the form of the electronic copy of the document in case of lack of data in GBD EL;

the agreement (contract) with indication of regulations on realization of the imported medicines only in the territory of the Republic of Kazakhstan;

the copy of the specification with indication of the producer and the country of the producer and the country of the producer of medicines with transfer into the state or Russian languages - in the form of the electronic document;

the document from the producer or its authorized representation confirming the distributor rights of the supplier to import of medicines from the territory of the country which is not the country - producer of medicine with transfer into the state or Russian languages - in the form of the electronic copy of the document.

In case of the address to the service provider and on the portal, data on the license, state registration (re-registration) as the individual entrepreneur - for physical persons, the data on state registration (re-registration) of the legal entity containing in the state information systems, the service provider receives from the corresponding state information systems in the form of the electronic documents certified by the digital signature of authorized persons of state bodies.

For import of medicines, unregistered in the territory of the Republic of Kazakhstan, uslugopoluchatel provide to the service provider the following documents:

1) for performing clinical trials and (or) testing (represent to Committee):

the statement, 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 on state or Russians;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

the contract (contract) or invoice (delivery note) with transfer into the state or Russian languages - in the form of the electronic document;

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

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 - in the form of the electronic copy of the document;

2) when importing samples of medicines for conducting examination, state registration, re-registration and modification of the registration file (provide in territorial subdivisions of Committee):/

the statement, 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;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

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 - in the form of the electronic document;

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 - in the form of the electronic copy of the document;

invoice (delivery note) with transfer into the state or Russian languages - in the form of the electronic document;

3) for holding exhibitions of medicines without the right of their further realization (represent to Committee):

the statement, 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;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

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

the contract (contract) or invoice (delivery note) with transfer into the state or Russian languages - in the form of the electronic document;

4) for delivery of health care according to vital testimonies of the specific patient or delivery of health care to the narrow contingent of patients from rare and (or) grow especially heavy pathology (represent to Committee):

the statement, 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 bodies of local public administration of health care of areas, the city 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;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

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) - in the form of the electronic copy of the document in case of lack of data in GBD EL;

the letter from bodies of local public administration of health care of areas, the city 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 - in the form of the electronic copy of the document;

the contract (contract) or invoice (delivery note) with transfer into the state or Russian languages - in the form of the electronic document;

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

5) for prevention and/or elimination of effects of emergency situations (represent to Committee):

the statement, 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;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

the contract (contract) or invoice (delivery note) with transfer into the state or Russian languages - in the form of the electronic document;

the letter from local executive bodies on emergency situation - in the form of the electronic copy of the document;

6) for humanitarian assistance in the cases determined by the Government of the Republic of Kazakhstan (represent to Committee):

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

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 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;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

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 - in the form of the electronic copy of the document;

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

the plan of target use (distribution) of the humanitarian assistance - in the form of the electronic document;

the document confirming quality of the imported medicines with transfer into the state or Russian languages - in the form of the electronic copy of the document;

7) for import of the unregistered medicinal substances made in the conditions of proper production practice (represent to territorial subdivisions of Committee):

the statement, 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 production of medicines or wholesale of medicines or the copy of the license for implementation of medical activities;

the copy of the agreement (contract) with indication of regulations on realization of the imported medicines only in the territory of the Republic of Kazakhstan, and also the copy of the specification with indication of the producer and the country of the producer and the country of the producer of medicines with transfer into the state or Russian languages;

the copy of the document from the producer or its authorized representation confirming the distributor rights of the supplier to import of medicinal substances from the territory of the country which is not the country - producer of medicine with transfer into the state or Russian languages;

the copy of the certificate confirming production compliance to requirements of proper production practice with indication of date of the last inspection with transfer into the state or Russian languages;

the inventory of the submitted documents.

In case of the address on the portal:

request in electronic form, the uslugopoluchatel signed by the EDS;

the license for occupation pharmaceutical activities with appendix on subspecies of the activities connected with production of medicines or wholesale of medicines or the license for implementation of medical activities - in the form of the electronic copy of the document in case of lack of data in GBD EL;

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