The Priority Review

Regulation Brief

EMA sets end-of-year submission dates for type I variations in 2026

EMA advises marketing authorisation holders to submit type IA annual updates, individual type IA and type IA IN variations, and super-groupings no later than 20 November 2026. Submissions received after 20 November will still be processed, but the outcome may not be issued until January 2027.

Primary source

EMA news release, October 1, 2026

Advice on ‘end-of-year’ submission dates for type I variations in 2026

Read the source: Advice on ‘end-of-year’ submission dates for type I variations in 2026 ema.europa.eu

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