Commission publishes new measures for the better lifecycle management of medicine authorisations

The new Variations Guidelines provide more flexibility through simplification and a risk-based approach, facilitating quicker and more efficient processing of variations, benefiting both marketing authorisation holders and regulatory authorities. The revision of the Variations Guidelines is the final step of the revision of the variation framework of medicines. The Guidelines will take effect as of 15 January 2026 and will replace the current guidelines.