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Streamlining Post-Authorization Changes: Key Updates to the EU Pharmaceutical Variation Guidelines

As part of the 2020 Pharmaceutical Strategy for Europe, the Commission is reviewing the current rules governing the procedures for post-authorization changes to the terms of a marketing authorization for medicines products for human use, with the purpose to make the lifecycle management of medicines more efficient and future-proof.

In this context, the Commission has now proposed amendments to the variation classification guideline. Read the guidelines here.

Overview of the Main Changes

  • New/Revised Tools: Super grouping of Type IA variations and annual updates of Type IA variations are among the new tools proposed. There will also be mandatory use of work-sharing to streamline processes.
  • Flexibility for Human Vaccines in Public Health Emergencies: The extension of flexibility to human vaccines addresses public health emergencies in the Union, ensuring rapid response capabilities.
  • Integration of Previous Article 5 Recommendations: Previous Article 5 recommendations for unforeseen variations have been integrated into the new framework.

Revised Variation Framework for Biological Active Substances and Finished Products

Strengthening Knowledge and Documentation Requirements for Active Substances: The framework for changes to active substances, including ASMFs and CEPs, has been updated to emphasize that the Marketing Authorization Holder (MAH) has adequate knowledge of the quality of the active substance. This includes strengthening the conditions and documentation requirements in line with the responsibilities of the MAH and finished product manufacturer.

Changes to Variations Affecting Medical Devices

  • New Scopes for Integral, Co-Packaged, and Product Information Referenced Devices: New scopes have been proposed to cover integral, co-packaged, and product information referenced devices, taking into account the new requirements of the Medical Devices Regulation and the Guideline on quality documentation for medicinal products when used with a medical device. This focuses on risk-based classification based on impact and risk rather than the type of device.
  • Simplification of Plasma Master File Variations: Plasma Master File variations have been reviewed and simplified, making it easier to manage changes.
  • Added and Deleted Changes in the Variation Framework: Some changes have been added or deleted, such as the deletion of changes currently being made through the XEVMPD database. Provisions have also been added to make it possible to explore additional options and further optimize lifecycle management.

Next Steps and Stakeholder Engagement

  • Open for Review Until August 23rd, 2024: The proposed amendments are open for review until August 23rd, 2024. Stakeholders are encouraged to provide feedback.
  • Anticipated Second Revision Post-EU Reform: A second revision to the variation framework is foreseen once the EU reform is completed.

Need Assistance? Celegence Can Help

Need help in understanding how the proposed changes are going to impact your way of working? Please reach out to Celegence. Our Regulatory Intelligence department can help you. Or do you need support in planning for and submitting your variations? Our Regulatory Affairs Strategy and Publishing & Submission colleagues are ready to help.

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