Updated Guidelines on the Variations Regulation - but not until January 2026
Medicinal Products, Variation Guidelines Elisabethann Wright Medicinal Products, Variation Guidelines Elisabethann Wright

Updated Guidelines on the Variations Regulation - but not until January 2026

‍Following adoption of Regulation (EC) No 1234/2008 (the Variations Regulation), which applied from January 2010, the European Commission published related Guidelines in 2013. The Guidelines have not subsequently been updated. As a result, the revisions to the Variations Regulation that occurred in 2021 and 2024 are not reflected in the existing version of the Guidelines.

‍The new Variation Guidelines that were recently published reflect the 2024 amendment of the Variations Regulation

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