ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 20, 2019 No. KR DSM-83

About modification and amendments in the order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015 No. 416 "About approval of regulations of the state services in the field of pharmaceutical activities"

According to the subitem 2) 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 May 29, 2015 No. 416 "About approval of regulations of the state services in the field of pharmaceutical activities" (registered in the Register of state registration of regulatory legal acts for No. 11484, published on July 29, 2015 in information system of law of Ad_let) the following changes and amendments:

state Item 1 in the following edition:

"1. Approve regulations of the state services:

1) "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) "Issue of the conclusion about safety, quality and efficiency of medicines and medical products" according to appendix 2 to this order;

3) "Issue of permission to performing clinical trial and (or) testing pharmacological and medicines, medical products" according to appendix 3 to this order;

4) "State registration, re-registration and modification of the registration file of medicine or medical product" according to appendix 4 to this order;

5) "Issue of the decision on approval (non-confirmation) of names of original medicines" according to appendix 5 to this order;

6) "Issue of the certificate on assignment of qualification category to specialists with pharmaceutical education" according to appendix 6 to this order;

7) "Issue of the certificate on pharmaceutical product" it agrees 7 to this order.";

8) "Licensing for pharmaceutical activities" it agrees 8 to this order;

9) "Licensing for implementation of activities in the field of drug trafficking, psychotropic substances and precursors in the field of health care" it agrees 9 to this order;

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

To be reworded as follows the regulations of the state service "Issue of the Conclusion about Safety, Quality and Efficiency of Medicines, Products of Medical Appointment and Medical Equipment" approved by the specified order, according to appendix 2 to this order;

To be reworded as follows the regulations of the state service "Issue of Permission to Performing Clinical Trial and (or) Testing Pharmacological and Medicines, Products of Medical Appointment and Medical Equipment" approved by the specified order, according to appendix 3 to this order;

To be reworded as follows the regulations of the state service "State Registration, Re-registration and Modification of the Registration File of Medicine, Product of Medical Appointment and Medical Equipment" approved by the specified order, according to appendix 4 to this order;

in Regulations of the state service "Issue of the Certificate on Assignment of Qualification Category to Specialists with Pharmaceutical Education", the approved specified order:

state Item 3 in the following edition:

"3. Result of rendering the state service - the certificate on assignment of the corresponding qualification category (further - the certificate) according to form of the state service "Issue of the Certificate on Assignment of Qualification Category to Specialists with Pharmaceutical Education" approved by appendix of 1 standard, No. approved by the order of the Minister of health and social development of the Republic of Kazakhstan of April 28, 2015 293, or the motivated answer about refusal in issue of the certificate in electronic form certified by the digital signature (further - the EDS) the authorized person of the service provider.

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

to state the subitem 4 of Item 5 in the following edition:

"4) by results of testing the head makes the decision on issue, or on refusal in issue of the certificate. The decision is drawn up in the form of the order. The contractor prepares the draft of the order based on the decision. The head signs the order and transfers to the responsible person to execution - completion date 1 (one) working day;";

to state the subitem 4 of Item 8 in the following edition:

"4) signing of the order and transfer on execution - completion date 1 (one) working day;";

state Item 9 in the following edition:

"9. Description of procedure for the address to the service provider, duration of processing of request of uslugopoluchatel:

1) for rendering the state service the uslugopoluchatel addresses on the portal.

The state service is performed in turn, without the accelerated servicing.

The list of the documents necessary for rendering the state service, the uslugopoluchatel provides according to Item 9 of the Standard.

Data of the identity document, the certificate 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".".

To be reworded as follows the reference book of business processes of rendering the state service "Issue of the Certificate on Assignment of Qualification Category to Specialists with Pharmaceutical Education" to Regulations according to appendix 5 to this order.

To be reworded as follows the regulations of the state service "Issue of the Certificate on Pharmaceutical Product" approved by the specified order, according to appendix 6 to this order;

add with appendices 8, 9 according to appendices 7, 8 to this order.

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

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

2) 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 the 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 the present having ordered 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), 3) of this Item.

3. To impose control of this order on supervising vice-the 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 20, 2019 No. KR DSM-83

Appendix 1

to the Order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015 No. 416

Regulations 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) appears Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan (further - Committee) or its territorial subdivisions (further - the service provider), through the web portal of "the electronic government": www.egov.kz or E-litsenzirovaniye web portal: http://www.elicense.kz/.

2. Form of rendering the state service: electronic.

3. The rendered state service issue of the allowing document (the letter about the approvals/conclusions on import/export of the registered and unregistered medicines in the Republic of Kazakhstan and medical products), or the motivated answer in refusal of rendering the state service in the bases is result, of the stipulated in Item 9-1 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 order of the Minister of health and social development of the Republic of Kazakhstan of April 28, 2015 No. 293, registered in the Register of state registration of regulatory legal acts No. 11338 (further - the Standard).

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