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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 №83

About approval of Rules of conducting pharmaceutical inspections

(as amended of the Decision of Council of the Eurasian economic commission of 08.02.2021 No. 7)

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, articles 7 and 10of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 96 of appendix №1 to the Regulations of work of the Euroasian 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 Rules of conducting pharmaceutical inspections.

2. 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.

 

Members of council of the Eurasian economic commission:

From the Republic of Armenia 

 

V. Gabriyelyan 

From the Republic of Belarus 

V. Matyushevsky 

From the Republic of Kazakhstan 

A. Mamin 

From the Kyrgyz Republic 

O. Pankratov 

From the Russian Federation  

I. Shuvalov 

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 № 83

Rules of conducting pharmaceutical inspections

I. General provisions

1. These rules establish single procedure for conducting pharmaceutical inspections of production of medicines on compliance to requirements of the rules of proper production practice of the Eurasian Economic Union approved by the Eurasian economic commission (further respectively – inspection, rules of proper production practice).

2. For conducting inspection the inspection team into which the leading pharmaceutical inspector, members of group, including pharmaceutical inspectors, the involved experts and trainees enter is created.

Responsibility for reliability of the results of inspection stated in the inspection report is assigned to pharmaceutical inspectors.

II. Operations procedure

3. Inspection is carried out by pharmaceutical inspectorate based on the plan of conducting inspections, the request for conducting inspection or upon the demand of authorized body of state member of the Eurasian Economic Union (further respectively – authorized body, state member, the Union) (for example, for the purpose of licensing, registration or conducting the investigations connected with quality of medicines) according to the program of conducting inspection of production of medicines for form according to appendix No. 1 (further – the program of inspection).

The pharmaceutical inspectorate carries out inspections of production of medicines on compliance to requirements of rules of proper production practice.

In case of positive result of inspection by authorized body the certificate in form according to appendix № 2 (on the form of authorized body) confirming object compliance to requirements of rules of proper production practice is issued (further – the certificate). Effective period of the certificate constitutes 3 years.

In case of negative result of the certificate it can be suspended or stopped. The procedure for issue, suspension and cancellation of the certificate is established by the Section V of these rules.

4. Inspection is subdivided into planned, unplanned and repeated (control).

Planned inspection – the inspection which is carried out according to the plan of pharmaceutical inspectorate taking into account certificate effective period based on the request of the subject in the field of drug circulation on receipt of the certificate or prolongation of its action.

Unplanned inspection – the inspection which is carried out by pharmaceutical inspectorate based on the statement of the subject in the field of drug circulation and also upon the demand of authorized body.

Repeated (control) inspection – the inspection which is carried out by authorized body (authorized organization) by results of earlier carried out inspection for the purpose of confirmation of elimination of the revealed discrepancies.

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