ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of October 13, 2020 No. KR DSM-129/2020

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

According to the subitem 19) article 10 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:

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

2. Declare invalid 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" (it is registered in the Register of state registration of regulatory legal acts of the Republic of Kazakhstan at No. 18530, it is published on April 18, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan).

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 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 ten calendar days after day of its first official publication.

No. KR DSM-129/2020 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of October 13, 2020

Rules of forming of pharmaceutical inspectorate, maintaining 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 19) of article 10 of the Code of the Republic of Kazakhstan "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. In these rules the following basic concepts are used:

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

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 divisions of state body in the sphere of drug circulation and medical products, its territorial subdivisions (further - state body) and (or) the organization determined by authorized body, performing inspection behind observance proper pharmaceutical the practician on medicines and requirements to implementation, maintenance and assessment of quality management system of medical products depending on potential risk of their application;

4) 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.

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

3. It is necessary for forming of pharmaceutical inspectorate:

1) quality system;

2) quality manual (management concept and developments of the quality system of the subject of inspection);

3) the regulations on pharmaceutical inspectorate provided by the quality system;

4) organizational structure;

5) standard operational procedures;

6) resources for conducting inspection.

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 affirms the head of pharmaceutical inspectorate.

5. The quality manual of pharmaceutical inspectorate provides the quality system and procedures of pharmaceutical inspectorate for personnel of pharmaceutical inspectorate 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.

6. The organizational structure of pharmaceutical inspectorate provides impartiality of pharmaceutical inspectors when conducting pharmaceutical inspections.

Functional obligations of the head and personnel of pharmaceutical inspectorate are determined by their job descriptions.

7. The quality system of pharmaceutical inspectorate provides:

1) determination of policy in the field of quality of pharmaceutical inspectorate;

2) distribution of obligations and powers between personnel of pharmaceutical inspectorate;

3) allocation of the resources necessary for realization of policy in the field of quality of pharmaceutical inspectorate;

4) procedures and procedure for planning, organization and conducting pharmaceutical inspections;

5) carrying out analysis of functioning of the quality system of pharmaceutical inspectorate;

6) maintaining and maintenance of management system documentation and records;

7) interaction of pharmaceutical inspectorate with accredited laboratories and the involved experts.

8. The personnel of pharmaceutical inspectorate carry out the job responsibilities, observe requirements of the quality manual of pharmaceutical inspectorate and procedures of pharmaceutical inspectorate adopted in the form of the written instrument.

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