The European Commission is reviewing the rules governing the procedures for post-authorisation changes to the terms of a marketing authorisation for human medicines.
EMA, HMA and the European Commission have announced a proposal for stakeholder consultation on the new guidelines for the classification of variations in marketing authorizations for medicinal products for human use. These guidelines no longer cover veterinary products.
Consultation Period: June 13 – August 23, 2024.
The key areas addressed include:
- Examination of variations in marketing authorization terms;
- Documentation required under variations.
The proposed changes are extensive and fundamentally alter many existing regulations.
Notably, there have been significant updates to the variation categories table from the regulation.
We strongly encourage all stakeholders to review and participate in these consultations. For a thorough understanding of the planned changes, we invite you to explore our services. Our expert consultants are up-to-date with all regulatory updates and can assist you effectively.
For more information on the consultation, please visit the European Commission’s website.