DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 № 82

About approval of General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union

Astana

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 10 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 95 of appendix № 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 № 98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 № 108 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" Council of the Eurasian economic commission decided :

1. Approve the enclosed General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union.

2. To provide to authorized bodies (authorized organizations) of state members of the Eurasian Economic Union reduction of quality systems of pharmaceutical inspectorates of state members of the Eurasian Economic Union in compliance with the General requirements approved by this Decision till July 1, 2016 and to inform on it the Eurasian economic commission.

3. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 №82

General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union

I. General provisions

1. These General requirements establish single approach to development and deployment of the quality system in activities of pharmaceutical inspectorates of state members of the Eurasian Economic Union (further respectively – state members, the Union) in case of accomplishment of pharmaceutical inspections.

These General requirements determine policy in the field of quality of pharmaceutical inspectorates, and also procedures and procedure for planning, the organization and conducting pharmaceutical inspections.

2. For the purposes of these General requirements concepts which mean the following are used:

"policy in the field of quality of pharmaceutical inspectorate" – assistance to protection of health of the population by means of conducting pharmaceutical inspections of subjects of drug circulation, and also by means of effective and rational activities of pharmaceutical inspectorates according to the acts entering the right of the Union in the field of drug circulation and the legislation of state members, implementations of the quality system of pharmaceutical inspectorates according to the quality manual of pharmaceutical inspectorate;

"the quality system of pharmaceutical inspectorate" – complex provided in the quality manual and in the procedures of pharmaceutical inspectorate of elements adopted in the form of the written instrument (such as organizational structure, responsibility, procedures, systems, processes and resources), and also the established measures necessary for goal achievement of pharmaceutical inspectorate in the field of quality and the established quality regulations;

"pharmaceutical inspection" – assessment of subjects of drug circulation, including the organizations of health care, for the purpose of establishment of compliance of pharmaceutical production and other activities for drug circulation to the acts entering the right of the Union;

"the pharmaceutical inspector" – the face authorized on conducting pharmaceutical inspection and included in the register of pharmaceutical inspectors of the Union;

"pharmaceutical inspectorate" – the structural division of authorized body (authorized organization) in the field of drug circulation of state member which is carrying out pharmaceutical inspections.

3. Pharmaceutical inspections are carried out by pharmaceutical inspectorates according to the acts entering the right of the Union in the field of drug circulation, and also the legislation of state members in the field.

4. Main objective of functioning of the quality system of pharmaceutical inspectorates is ensuring uniformity, high level of conducting pharmaceutical inspections and mutual recognition of results of pharmaceutical inspections.

5. These General requirements are held for use pharmaceutical inspectorates as basis for development of own quality system of pharmaceutical inspectorate.

6. These General requirements are developed taking into account recommendations of System of cooperation about pharmaceutical inspections (PIC/S) of PI 002-3 "Recommendation on Quality System Requirements for Pharmaceutical Inspectorates" and the state standard specification ISO 19011-2013 standard "Guidelines on audit of systems of management".

II. Quality manual

7. The pharmaceutical inspectorate shall develop and approve the quality manual according to these General requirements. The quality manual of pharmaceutical inspectorate shall cover all aspects of activities of pharmaceutical inspectorate and include the procedures of the quality system of pharmaceutical inspectorate and (or) the reference to them adopted in the form of the written instrument.

8. The quality manual of pharmaceutical inspectorate affirms the head of pharmaceutical inspectorate.

9. 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:

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