Today, we’re bringing you a set of bite-sized insights into the new Variations Guideline (Q1 2026), featuring the 4 key pills by Ana Viñas that we have shared over the past couple of months.
Scope
Designed to support Marketing Authorisation Holders (MAHs), these insights aim to strengthen regulatory strategies related to variations to the terms of Marketing Authorisations (MAs) for medicinal products for human use.
What’s inside?
A practical breakdown of some of the most critical aspects identified by applicants:
1️⃣ How to use a Certificate of Suitability (CEP) in the context of a Marketing Authorisation Variation
2️⃣ How to prepare the Precise Scope section of the variation application form
3️⃣ How to select the correct procedure and variation category/number
4️⃣ What the inclusion of Article 5 recommendations (related to unforeseen variations) means for applicants
Have a look at the document for a full overview here: Carrusel LCM Recap
Stay tuned as we continue sharing expert insights to help you stay ahead in an evolving regulatory landscape.
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
Need support with variations or regulatory strategies? Our team will be happy to help. Contact us at: [email protected]
