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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of April 15, 2019 No. KR DSM-37

About approval of Rules of forming of pharmaceutical inspectorate, maintaining the register of pharmaceutical inspectors of the Republic of Kazakhstan

According to Article of the subitem 71) Item 1 of article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" of September 18, 2015 PRIKAZYVAYU:

1. Approve the enclosed Rules of forming of pharmaceutical inspectorate, maintaining the register of pharmaceutical inspectors of the Republic of Kazakhstan.

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

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" the Ministries of Justice 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 joint 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 execution 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.

Minister of Health of the Republic of Kazakhstan

E.Birtanov

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of April 15, 2019 No. KR DSM-37

About approval of Rules of forming of pharmaceutical inspectorate, maintaining the register of pharmaceutical inspectors of the Republic of Kazakhstan

Chapter 1. General provisions

1. These rules of forming of pharmaceutical inspectorate, maintaining the register of pharmaceutical inspectors of the Republic of Kazakhstan are developed according to the subitem 71) 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" and determine procedure for forming of pharmaceutical inspectorate, maintaining the register of pharmaceutical inspectors of the Republic of Kazakhstan.

2. For the purposes of these rules the following basic concepts are used:

1) pharmaceutical inspectorate for proper pharmaceutical practicians (further - pharmaceutical inspection) - object assessment in the sphere of drug circulation for the purpose of determination of its compliance to requirements proper pharmaceutical the practician of the Republic of Kazakhstan and (or) the Eurasian Economic Union;

2) the pharmaceutical proper pharmaceutical practicians inspector - the face authorized on implementation of functions on conducting pharmaceutical inspection on proper pharmaceutical practicians and included in the register of pharmaceutical inspectors of the Republic of Kazakhstan;

3) pharmaceutical inspectorate on proper pharmaceutical practicians - structural division of state body in the sphere of drug circulation and medical products and its territorial subdivisions (further - state body), performing pharmaceutical inspection;

4) the register of pharmaceutical inspectors of the Republic of Kazakhstan - the information resource of authorized body containing the information about pharmaceutical inspectors of the Republic of Kazakhstan;

Chapter 2. Procedure for forming of pharmaceutical inspectorate of the Republic of Kazakhstan

3. It is necessary for forming of pharmaceutical inspectorate:

1) quality manual;

2) organizational structure;

3) quality system;

4) resources.

4. The quality manual of pharmaceutical inspectorate which is covering all aspects of activities of pharmaceutical inspectorate and including the procedures of the quality system of pharmaceutical inspectorate and (or) the reference to them adopted in the form of the written instrument also affirms the head of pharmaceutical inspectorate.

5. The quality manual of pharmaceutical inspectorate establishes requirements and procedures of the quality system of pharmaceutical inspectorate for personnel of pharmaceutical inspectorate and the involved experts and is used for:

1) confirmations of availability at personnel of pharmaceutical inspectorate of the sufficient qualifications, knowledge and experience allowing to fulfill the requirements established by the current legislation of the Republic of Kazakhstan in the sphere of drug circulation and medical products;

2) determinations of conditions in case of which there is need for carrying out internal and external audits of the quality system of pharmaceutical inspectorate.

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