DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 8, 2021 No. 7

About modification of Rules of conducting pharmaceutical inspections

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, articles 7 and 10 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 96 of appendix 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 solved:

1. Bring in the Rules of conducting pharmaceutical inspections approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83, of change according to appendix.

2. The Eurasian economic commission together with authorized bodies of state members of the Eurasian Economic Union to develop the project of changes in the Rules of conducting pharmaceutical inspections approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83, in the part concerning procedure for conducting pharmaceutical inspections with use of means of remote interaction. Before entry into force of the specified project when conducting pharmaceutical inspections with use of means of remote interaction to be guided by the existing rules of conducting inspections and the quality manual of the pharmaceutical inspectorate which is carrying out inspection.

3. This Decision becomes effective after 10 calendar days from the date of its official publication and extends to the legal relationship which arose since January 1, 2021.

Members of council of the Eurasian economic commission:

Appendix

to the Decision of Council of the Eurasian economic commission of February 8, 2021 No. 7

The changes made to Rules of conducting pharmaceutical inspections

1. Add item 4 with the paragraph of the following content:

"In the cases established by appendix No. 2.1 to these rules conducting pharmaceutical inspections with use of means of remote interaction is allowed (for example, by means of audio-or video conference).".

2. Add with appendix No. 2.1 of the following content:

"Appendix No. 2.1

to Rules

Cases of conducting pharmaceutical inspection with use of means of remote interaction (for example, by means of audio-or video conference)

1. Conducting pharmaceutical inspections with use of means of remote interaction (for example, by means of audio-or video conference) according to acts of bodies of the Eurasian Economic Union in the following cases is allowed according to the solution of pharmaceutical inspectorate:

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 political, medical or other reasons).

2. Before the pharmaceutical inspection which is carried out with use of means of remote interaction, the manufacturing organization shall confirm these geolocations (width, longitude) of the location of the production site.".

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