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EAEU amended rules for marketing authorization and expert examination of medicines
At its meeting held on May 29, the Eurasian Economic Commission's Council amended the Rules for Marketing Authorization and Expert Examination of Medicines for Human Use.
The administrative part of the procedure for making amendments to the marketing authorization application of an authorized medicinal product has been updated with due regard to law enforcement. The list has been expanded and the types of amendments to the marketing authorization application that do not require expert work and are carried out in a notification procedure have been clarified.
Valentin Tataritsky, EEC Minister in charge of Technical Regulation, noted: “The introduction of the risk-based approach makes it possible to reduce the regulatory burden and expand the use of the notification procedure when making amendments to the marketing authorization application”.
The decision of the Commission's Council will make it possible to optimize the procedures performed by the authorized bodies (expert organizations) of the Eurasian Economic Union States when carrying out expert work and assessing the marketing authorization application for different types of amendments in respect of authorized medicines. The preparation of materials for marketing authorization application by pharmaceutical manufacturers is being optimized as well.
This simplified procedure for amending the marketing authorization application will apply to applications submitted from March 1, 2024 (i.e. the provisions of the Decision adopted by the Council apply to legal relations arising from March 1 this year).
