Draft EC guidelines on the details of the various categories of variations and operation of the procedures
Following the amended Variations Regulation No 1234/2008 (amended by Commission Delegated Regulation (EU) 2024/1701) applicable since 1 January 2025, the European Commission has now published a draft version of the new EC guidelines on the details of the various categories of variations and operation of the procedures and expects them to apply from 15 January 2026 (as provided in the published draft version of variations guidelines). Updated guidance is expected to be published by the end of the month regarding the submission of variations application of the new variation framework...
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