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18.08.2023 (Обновлено: 22.08.2023 10:29)

EAEU experts working to simplify medicine registration

The matters of simplifying the procedure for aligning the marketing authorization applications for medicinal products with the requirements of the Eurasian Economic Union were reviewed during a regular meeting of the sector-specific expert committee of the Commission on Medicinal Products chaired by Viktor Nazarenko, Minister in charge of Technical Regulation.

 

"The matters of simplifying registration procedures for the purpose of ensuring sustainable functioning of the common market and circulation of medicines in it in accordance with the Union's requirements are critical and a subject of continuous discussion at fora, conferences and meetings with the business community," noted the EEC Minister.

The possibility of such simplification is provided for in the draft decision of the Eurasian Economic Commission Council "On Making Amendments to the Rules of Marketing Authorization and Assessment of Medicinal Products for Human Use" that was reviewed and approved by the Committee members during the meeting.

The document provides for modifying some provisions of the Rules: in particular, the changes affect the rules for issuing indefinite marketing authorizations as part of the alignment procedure for medicines that have been authorized for over 5 years in the reference Member State. In addition, there are optimized possibilities for amending marketing authorization applications simultaneously with the alignment procedure.

Moreover, the changes clarified the requirements for the scope of documents that should be submitted as part of a marketing authorization application regarding medicines already circulating in the EAEU market in the framework of the alignment and registration procedure if such documents are available in other control procedures.

 

 It is planned to consider the draft decision of the EEC Council on this matter at the Board's meeting in Q4 2023; based on that, the Board of the Commission will adopt a disposition of approval.

In addition to the draft document, the experts approved the draft recommendation of the Board of the Eurasian Economic Commission "On the Guidance on Working with Laboratory (Experimental) Animals in Preclinical (Non-Clinical) Studies", as well as updated the composition of the working group on establishing common approaches to regulating the circulation of medicines within the Eurasian Economic Union.