DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of August 1, 2025 No. 60

About modification of the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83

According to Articles 6, of 7, 10 and 12 Agreements on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Items 81, of 83, the 87 and 96 appendices No. 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 No. 98, Council of the Eurasian economic commission DECIDED:

1. Bring in the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83 "About approval of Rules of conducting pharmaceutical inspections" changes according to appendix.

2. This Decision becomes effective after 30 calendar days from the date of its official publication.

Appendix

to the Decision of Council of the Eurasian economic commission of August 1, 2025 No. 60

The changes made to the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83

1. In word preamble "Items 81, 83 and 96" shall be replaced with words "Items 81, of 83, 87 and 96".

2. Add Item 1 with the paragraph of the following content:

"Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper laboratory practice of the Eurasian Economic Union in the field of drug circulation.".

3. Add with Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper laboratory practice of the Eurasian Economic Union in the field of drug circulation of the following content:

"Are approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83

Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper laboratory practice of the Eurasian Economic Union in the field of drug circulation

I. General provisions

1. These rules establish single procedure for conducting pharmaceutical inspections on compliance to requirements of the Rules of proper laboratory practice of the Eurasian Economic Union in the field of drug circulation approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 81 (further respectively – inspections, Rules of laboratory practice), within holding procedures of registration, confirmation (re-registration) of medicine, modification of the registration file of medicine and other procedures connected with registration (further – registration procedures).

2. Inspection is carried out for the purpose of determination of compliance of preclinical (not clinical) researches to requirements of Rules of laboratory practice, including quality and accuracy of the data, received when carrying out preclinical (not clinical) research of medicine, in case of identification of the facts calling into question reliability of the data provided by the applicant in the registration file of medicine concerning the conducted preclinical (not clinical) researches of medicines.

For the purposes of these rules concept "inspection" is applied to any inspections which are carried out by pharmaceutical inspectorate (exit, remote and documentary inspections and checks).

3. Inspection includes conducting verification of documents, objects (infrastructure), records, agreements on quality assurance and any other sources which are regarded by authorized body of state member of the Eurasian Economic Union (further respectively – state member, the Union) as belonging to preclinical (not clinical) research and are in the research organization (test laboratory (center)) (further – the inspected subject), on the sponsor's objects (developer of medicine) or in other organizations participating in preclinical (not clinical) research and requiring conducting inspection.

4. In case conducting inspection of the inspected subject or other objects participating in preclinical (not clinical) research according to the decision of authorized body of state member on the basis risk is not required - the oriented approach conducting documentary inspection is allowed.

5. Inspection is carried out taking into account provisions of Sections VII and VIII of Rules of laboratory practice.

6. According to the solution of pharmaceutical inspectorate conducting inspections with use of means of remote interaction (for example, by means of audio-or video conference) in the following cases is allowed:

a) origin threat, origin and liquidation of emergency situation and (or) emergence of threat of spread of the epidemic diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors;

b) emergence of force majeure circumstances or the parties of circumstances, independent of will, which pose threat of damnification of life and to health of inspectors (for example, for medical or other reasons).

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