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Ministry of Justice

Republic of Kazakhstan

On June 16, 2020 No. 20863

I.O'S ORDER. MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of June 15, 2020 No. KR DSM-65/2020

About some questions of rendering the state services in the field of pharmaceutical activities

According to the subitem 1) article 10 of the Law of the Republic of Kazakhstan of April 15, 2013 "About the state services" and Item 2 of article 50 of the Law of the Republic of Kazakhstan of April 6, 2016 "About legal acts", PRIKAZYVAYU:

1. Approve:

1) Rules of rendering the state service "Licensing for Pharmaceutical Activities", according to appendix 1 to this order;

2) Rules of rendering the state services "Licensing for Implementation of Activities in the field of Drug Trafficking, Psychotropic Substances and Precursors in the field of Health Care", according to appendix 2 to this order.

2. Recognize invalid some orders of the Minister of Health of the Republic of Kazakhstan and the Minister of health and social development of the Republic of Kazakhstan, according to appendix 3 to this order.

3. To provide to committee of quality control and safety of goods and services 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) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

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

5. This order becomes effective on the expirations of twenty one calendar days after day of its first official publication.

Acting minister of health care of the Republic of Kazakhstan

O. Abishev

Appendix 1

to the Order of the Acting minister of health care of the Republic of Kazakhstan of June 15, 2020 No. KR DSM-65/2020

Rules of rendering the state service "Licensing for Pharmaceutical Activities"

Chapter 1. General provisions

1. These rules of rendering the state service "Licensing for Pharmaceutical Activities" (further – Rules) are developed according to the subitem 1) of Article 10 and article 14 of the Law of the Republic of Kazakhstan of April 15, 2013 "About the state services" (further – the Law) and subitem 29-8) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system".

2. In these rules the following basic concepts are used:

1) the state service – one of the forms of realization of the separate state functions performed in individual procedure according to the address or without address of uslugopoluchatel and directed to realization of their rights, freedoms and legitimate interests, provision of the corresponding material or non-material benefits by it;

2) the standard of the state service – the list of the main requirements to rendering the state service including characteristics of process, form, content and result of rendering, and also other data taking into account features of provision of the state service;

3) the web portal of "the electronic government" – the information system representing single window of access to all consolidated government information including the regulatory legal base, and to the state services, services in issue of specifications on connection to the networks of subjects of natural monopolies and services of subjects of the quasi-public sector rendered electronically;

4) allowing control – the activities of allowing bodies directed to check of compliance of the applicant to qualification or allowing requirements before issue of permission and (or) appendix to permission and also ensuring compliance by licensees and owners of permissions of the second category of the legislation of the Republic of Kazakhstan on permissions and notifications after their issue;

5) qualification requirements – set of the quantitative and high-quality standard rates and indicators characterizing capability of the applicant and licensee to be engaged in the separate licensed type of activity and (or) subspecies of the licensed type of activity, shown as when licensing and (or) appendices to the license, and throughout the entire period of time of its reality;

6) the digital signature (further – the EDS) – set of electronic digital symbols created by means of the digital signature and confirming reliability of the electronic document, its accessory and invariance of content.

Chapter 2. Procedure for rendering the state service

3. For receipt of the license for pharmaceutical activities the uslugopoluchatel sends to territorial department Committee of quality control and safety of goods and services of the Ministry of Health of the Republic of Kazakhstan (further - the service provider) the statement in form according to appendix 2, of 3, of 5, 6 to these rules and form of data according to appendix 4 to these rules, certified by the digital signature (further – the EDS), through the web portal of "the electronic government" www.egov.kz, www.elicense.kz (further – the Portal).

4. The list of the main requirements to rendering the state service including characteristics of process, form, content and result of rendering and also other data taking into account features of provision of the state service is provided in the Standard of the state service "Licensing for Pharmaceutical Activities" according to appendix 1 to these rules.

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