DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of June 10, 2022 No. 96

About temporary measures for establishment of features of drug circulation for medical application

According to articles 30 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Articles 4, of 7, 8 and 10 Agreements on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, the order of Council of the Eurasian economic commission of March 17, 2022 No. 12 in the conditions of use of special economic measures in case of absence or emergence of threat of lack of medicines in the markets of state members of the Eurasian Economic Union (further respectively - state members, the Union) for the purpose of protection of life and health of the population of state members, Council of the Eurasian economic commission solved ensuring uninterrupted drug circulation within the Union:

1. Determine that:

a) authorized bodies of state members in the field of drug circulation (further - authorized bodies) have the right to establish the temporary procedure for drug circulation (including registration of medicines and modification of the registration file of medicines) operating till December 31, 2023, having kept possibility of implementation of registration of medicines according to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78;

b) the authorized bodies performing issue according to the right of the Union of registration certificates of medicines for medical application and certificates of conformity of the producer to requirements of Rules of proper production practice of the Eurasian Economic Union (further - certificates) having the right to prolong action of these documents if terms of their action expire from January 1, 2022 to December 31, 2022, for 12 months from the date of, the expiration of such terms following behind day.

Authorized bodies provide possibility of modification of certificates based on the decisions without conducting inspection in the period of effective period of certificates in case of the change of the name and (or) the location address of the producer or the foreign producer, without change of their actual stay, the list made on the same production site and in the same conditions of the medicines specified in the certificate taking into account prolongation of effective period of the certificate according to this subitem. In case of risk of deficit of medicines in the markets of state members (including in connection with introduction of economic measures concerning one or several state members) authorized bodies have the right to extend repeatedly action of the documents specified in this subitem, but no more than till December 31, 2024.

2. Grant to applicants the right to registration of medicines in case of impossibility of submission of the existing document confirming compliance of the production site (production sites) to requirements of proper production practice of the Union in case of submission till December 31, 2023 of the statement for medicine registration, modification of the registration file of medicine, registration confirmation (re-registration) or for reduction of the registration file of medicine in compliance with requirements of the Union instead of this document to submit as a part of the registration file the application for conducting inspection of the production site (production sites) of medicine during registration of medicine, modification of the registration file or its reductions in compliance with requirements of the Union, based on which such inspection can be carried out to the period of implementation of registration procedures or is included in the plan of conducting inspections by pharmaceutical inspectorate of state member.

3. This Decision becomes effective after 10 calendar days from the date of its official publication.

Members of council of the Eurasian economic commission:

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info