Commission proposes guidelines to flesh out the newly finalized Variations Regulation

BY KIRSTEN MESSMER, PHD, RAC

This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. This regulation provides the framework for implementing post-authorization changes, or “variations,” to a medicinal product, and the updates implement efficiencies and incorporate current regulatory practice used by the EMA and national regulators. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

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