The European Commission has officially adopted revisions to the Variations Regulation, set to take effect in January 2025. This update brings important changes to the regulatory landscape, and the accompanying Variations Guideline is also being updated to align with the new framework.
Key guidance for applying the amended regulation is available:
- MRP/DCP Variations: https://bit.ly/49Dggzl
- Centralized Procedures (CP): https://bit.ly/41uSfsr
At Asphalion, we are ready to support you in navigating these changes. Our services include:
- Latest updates from industry working groups
- Expert preparation and submission of variation applications
- Guidance on Variations Grouping and Worksharing
- Support during regulatory agency consultations
- Compliance & QA assurance
- Tailored trainings and workshops
- End-to-end life-cycle management
Want to stay ahead of these changes and ensure compliance? Schedule a quick call with us to understand how these updates may impact your products: SCHEDULE A FREE MEETING.
You can also contact us at: [email protected]
