In this first pill of our new series on the new Variations Guideline, Ana Viñas explains how to use a Certificate of Suitability (CEP) in the context of a Marketing Authorisation Variation (MAV), covering key dossier sections, variation classification, grouping possibilities, and MAH responsibilities.
Read all the key considerations and practical guidance in the document we have prepared.
If you require any support with your variations, contact us at: [email protected]
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