ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 6, 2019 No. KR DSM-68

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" (registered in the Register of state registration of regulatory legal acts for No. 11338, published on July 16, 2015 in information system of law of Ad_let) the following changes and amendments:

state Item 1 in the following edition:

"1. Approve:

1) 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 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 field 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.";

To be reworded as follows 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 and Medical Products" approved by the specified order, according to appendix 1 to this order;

To be reworded as follows the standard of the state service "Licensing for Pharmaceutical Activities" approved by the specified order, according to appendix 2 to this order;

To be reworded as follows the standard of the state service "Licensing for Implementation of Activities in the field of Drug Trafficking, Psychotropic Substances and Precursors in the field of Health Care" approved by the specified order, according to appendix 3 to this order;

To be reworded as follows the standard of the state service "Issue of Permission to Performing Clinical Trial and (or) Testing Pharmacological and Medicines, Medical Products" approved by the specified order, according to appendix 4 to this order;

To be reworded as follows the standard of the state service "State Registration, Re-registration and Modification of the Registration File of Medicine or Medical Product" approved by the specified order, according to appendix 5 to this order;

To be reworded as follows the standard of the state service "Issue of the Conclusion about Safety, Quality and Efficiency of Medicines and Medical Products" approved by the specified order, according to appendix 6 to this order;

To be reworded as follows the standard of the state service "Issue of the Certificate on Pharmaceutical Product" approved by the specified order, according to appendix 7 to this order;

in the Standard of the state service ""Issue of the certificate on assignment of qualification category to specialists with the pharmaceutical education" approved by the specified order:

state item 4 in the following edition:

"4. The term of rendering the state service in case of the address on the portal - 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.";

state Item 6 in the following edition:

"6. Result of rendering the state service - the certificate on assignment of the corresponding qualification category (further - the certificate) according to appendix 1 to this standard of the state service, or the motivated answer about refusal in rendering the state service in the bases, stipulated in Item 10 these standards. The certificate is granted for a period of 5 years based on positive results of assessment of professional readiness and confirmation of conformity of qualification of specialists or is termless for persons who received the first, highest category three times in a row on the declared specialty.

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

The result of rendering the state service goes to uslugopoluchatel to "personal account" in electronic form, certified by the digital signature (further - the EDS) the authorized person of the service provider.";

state Item 9 in the following edition:

"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 receipt of the certificate with for a period of 5 (five) years with assignment of the corresponding qualification category:

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

form of data in form according to appendix 3 to this standard of the state service and the following documents;

the electronic copy of the diploma about education (data since 2015 receive from the corresponding state information systems through lock of "the electronic government");

electronic copy of result of assessment of professional readiness and confirmation of conformity of qualification of specialists;

the electronic copy of the certificate of retraining on the declared specialty (in the presence);

electronic copies of the documents confirming participation in action, promoting continuous professional development for the last 5 (five) years on the declared specialty;

the electronic copy of the certificate of recognition and (or) nostrification of the education documents, for persons which got medical education outside the Republic of Kazakhstan;

certificates on change of name, the middle name, surname either on marriage or on annulment of marriage, for persons which changed surname, name or middle name (in case of its availability) after receipt of education documents of uslugopoluchatel, the service provider receives from the corresponding state information systems through lock of "the electronic government";

for receipt of the termless certificate on assignment of the first or highest qualification category:

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

form of data in form according to appendix 5 to this standard of the state service and the following documents;

data of the identity document of uslugopoluchatel, the service provider receives from the corresponding state information systems through lock of "the electronic government";

the electronic copy of the certificate on advanced training on the declared specialty for the last five years at the time of submission of documents, in volume of at least 216 hours for specialists with the higher and secondary pharmaceutical education;

electronic copies of earlier granted three equivalent certificates, or certificates with assignment of the first or highest qualification category.

Reclamation from uslugopoluchatel of documents which can be received from information systems is not allowed.

When giving the uslugopoluchatel of all necessary documents through the portal - in "personal account" of uslugopoluchatel displays the status about acceptance of request for rendering the state service with indication of date, time and the place of passing of testing, interview, assessment (in case of its admission by results of verification of documents to testing and by results of testing to interview, assessment).";

in appendix 3 to the specified standard of the state service:

exclude Item 48.

2. To provide to committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation to the Republic of Kazakhstan:

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

2) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "Institute of the legislation and legal information of the Republic of Kazakhstan" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2), and 3) of this Item.

3. To impose control of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

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

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of May 6, 2019 No. KR DSM-68

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 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"

Chapter 1. General provisions

1. 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" (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, http://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 approval / 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 load with transfer 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 effects 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 transfer 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 transfer 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 transfer 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 ate, 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 approval 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 approval from state body in the field 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 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 or Russian languages (certificates of the analysis or certificates on pharmaceutical product of SRR);

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 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 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 load to the receiver with transfer 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 transfer 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 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;

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 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 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 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 field of drug circulation and medical products;

the electronic copy of the agreement (contract) or invoice (delivery note) with transfer 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 transfer 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 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 electronic copy of the document confirming humanitarian character of load to the receiver with transfer 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 effects 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 transfer) 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 ate, the electronic copy of the license for occupation with 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 approval 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 transfer) on the Kazakh or Russian languages;

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

2) for prevention and/or elimination of effects 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 transfer) on the Kazakh or Russian languages;

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

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