On March 11, 2024, the European Commission adopted an update to the Variations Regulation, which will come into force on January 15, 2025.
In connection with this update, changes are also being implemented in the Variations Guideline. Companies should start preparing for these changes to ensure smooth compliance and efficient lifecycle management of their products.
Have a look at the SUMMARY DOCUMENT about Variations where all the upcoming changes are compiled for easy reference.
How Asphalion can help:
- Strategic advice on adapting to the new regulation
- Preparation and submission of variations
- Variations grouping and worksharing
- Stakeholder consultation
- Quality assurance & compliance support
- Trainings & workshops for teams
- Life-cycle management strategies
Our experts guide MAHs through the regulatory updates, ensuring timely submissions, compliance, and optimized product management. Contact us! [email protected]
