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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 16, 2022 No. KR DSM-45

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

According to the subitem 5) article 10 of the Code of the Republic of Kazakhstan "About health of the people and health care system", the subitem 1) Article 10 and article 14 of the Law of the Republic of Kazakhstan "About the state services" and Item 2 of article 50 of the Law of the Republic of Kazakhstan "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 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 2 to this order.

2. Declare invalid the order of the acting minister of health care 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" (it is registered in the Register of state registration of regulatory legal acts at No. 20863).

3. To provide to committee of medical and pharmaceutical control 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 in the Ministry of Justice of the Republic of Kazakhstan 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 execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

5. This order becomes effective after sixty calendar days after day of its first official publication.

Minister of Health of the Republic of Kazakhstan

A. Giniyat

It is approved

Ministry of digital development, innovations and aerospace industry of the Republic of Kazakhstan

 

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of May 16, 2022 No. KR DSM-45

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 5) of article 10 of the Code of the Republic of Kazakhstan "About health of the people and health care system", the subitem 1) of Article 10 and article 14 of the Law of the Republic of Kazakhstan "About the state services" (further – the Law).

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

1) 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;

2) 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;

3) 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;

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) 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;

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.

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