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The document ceased to be valid since November 18, 2020 according to Item 2 of the Order of the Minister of Health of the Republic of Kazakhstan of October 22, 2020 No. KR DSM-148/2020

ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of April 10, 2019 No. KR DSM-25

About introduction of amendments to the order of the Minister of health and social development of the Republic of Kazakhstan of January 23, 2015 No. 27 "About approval of the qualification requirements imposed to medical and pharmaceutical activities"

According to the subitem 74) 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", I ORDER:

1. Bring in the order of the Minister of health and social development of the Republic of Kazakhstan of January 23, 2015 No. 27 "About approval of the qualification requirements imposed to medical and pharmaceutical activities" (it is registered in the Register of state registration of regulatory legal acts at No. 10600, it is published on April 14, 2015 in information system of law of Ad_let) the following changes:

in the Qualification requirements imposed to medical and pharmaceutical activities, approved by the specified order:

in the Section "for pharmaceutical activities":

2, to state line, sequence number in the following edition:

"

2.

for legal entities and physical persons - the equipment and furniture, stock, devices and the equipment for ensuring quality control and observance of conditions of production, production, storage and realization of medicines and medical products according to regulatory legal acts; the automotive vehicle with the corresponding cases and refrigeration and other equipment if necessary providing observance of storage conditions and realization of medicines and medical products for mobile pharmaceutical unit for the remote rural zones

data on compliance to the qualification requirements imposed when licensing pharmaceutical activities in form according to appendix 2 to these qualification requirements



     ";

4, to state line, sequence number in the following edition:

"

4

for legal entities - the corresponding education and length of service in the specialty according to the declared subspecies of pharmaceutical activities:
1) for the organizations for production of medicines and medical products:
- the higher pharmaceutical or chemical and technological, chemical education and length of service in at least three years at division managers which is directly borrowed on production of medicines and medical products, or technical from the division managers who are directly occupied on production of medical products;
- the higher pharmaceutical or chemical, biological education at the workers exercising quality control of medicines and medical products, or technical at the workers exercising quality control of medical products;
- technical education at the equipment maintenance specialist used in engineering procedure of production of medicines and medical products;
2) for the organizations in the field of drug circulation and the medical products performing production of medicines (further - the drugstore performing production of medicines):
- the higher pharmaceutical education and length of service at least three years in the specialty at the head the drugstore performing production of medicines, and its production departments, and also the workers exercising quality control of medicines and medical products;
- the higher or secondary pharmaceutical education at the workers performing direct production of medicines and leave of the made medicines;
- secondary pharmaceutical education and length of service at least three years of work at the head drugstore and its production departments in the absence of specialists with the higher pharmaceutical education in the district center and the rural zone;
3) for drugstores:
- the higher or secondary pharmaceutical education (length of service in at least three years) at the head drugstore or its departments;
- the higher or secondary pharmaceutical education at the specialists enabling the realization of medicines and medical products;
- in case of realization of medicines on the Internet transport availability on the property right or leases for delivery implementation by the method which is not allowing change of their properties in the course of storage and transportation;
4) for pharmaceutical Item in the organizations of health care giving primary medical and sanitary, consulting and diagnostic help (further - pharmaceutical Item):
- the higher or secondary pharmaceutical education (length of service in at least three years) at the pharmacy manager, and also workers enabling the realization of medicines and medical products. In pharmaceutical Items for the remote rural zones where there are no drugstores, in case of absence of specialists with pharmaceutical education, realization of medicines and medical products is performed by the specialists with medical education certified according to the procedure, determined by authorized body in the field of health care;
5) for pharmaceutical warehouse:
- the higher pharmaceutical education and length of service at least three years at the head of the pharmaceutical warehouse and the worker enabling the realization of medicines and medical products;
- the higher or secondary pharmaceutical education at heads of departments of pharmaceutical warehouse and workers performing acceptance, storage and leave of medicines and medical products;
6) for mobile pharmaceutical unit for the remote rural zones (further - mobile pharmaceutical unit) where there are no drugstores:
- the higher or secondary pharmaceutical education at the manager of mobile pharmaceutical unit, and also workers enabling the realization of medicines and medical products. In case of absence of specialists with pharmaceutical education, realization of medicines and medical products in mobile pharmaceutical units is performed by the specialists with medical education certified according to the procedure, determined by authorized body in the field of health care;
7) for production of medical products:
- the higher or secondary pharmaceutical, medical or technical education

data on compliance to the qualification requirements imposed when licensing pharmaceutical activities in form according to appendix 2 to these qualification requirements

The service provider receives data on the higher or secondary pharmaceutical education from information system of the Ministry of Education and Science of the Republic of Kazakhstan (the data since 2015), except for persons which ended till 2015 and also the faces which ended outside the territory of the Republic of Kazakhstan which provide the electronic copy of the education document

     ";

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 "The republican center of legal information" 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 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 execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

4. This order becomes effective after twenty one calendar days after day of their first official publication.

Minister of Health of the Republic of Kazakhstan

E.Birtanov

 

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