We are releasing the third Pill of our series on variations, where our expert Ana Viñas breaks down key topics of the new Variations Guideline. In this pill, Ana guides us on how to select the correct Procedure and the correct Variation procedure number in the context of a Marketing Authorisation Variation (MAV).
Lifecycle management requires strategic planning — understanding how changes interact with the Variation Regulation is essential to avoid delays and compliance risks.
Have a look at the document for a comprehensive guide on selecting the best procedure and the most appropriate variation procedure: PILL 3
Furthermore, at Asphalion, we have developed a free interactive regulatory tool, AsphaMapper, designed to simplify the comparison between the old and new EU Variations Guidelines, helping regulatory teams stay compliant and plan with confidence.
Explore the free tool here: ASPHAMAPPER
Next pill coming soon! Stay tuned!
If you need support with variations or regulatory strategies, our team will be happy to help. Contact us at: [email protected]
