News for pharmaceutical companies operating in the EU!
The European Medicines Agency (EMA) has implemented significant updates to its post‑approval application guidance, effective 1 January 2025. These updates aim to improve clarity, enhance efficiency, and ensure regulatory alignment across the EU and will impact how post‑approval applications are prepared and submitted.
Key Changes Include:
- The Article 5 procedure for classification of unforeseen variations
- Annual update for minor variations of type IA
- Procedure for grouping and super-grouping of Type IA variations
- Annual update of human influenza or human coronavirus vaccines
- Mandatory (same MAH) and voluntary (different MAHs) use of the work-sharing procedure
- Variations to human vaccines for public health emergencies
- Updates to the Annexes
How Starodub Can Support You
Starodub can support pharmaceutical companies with the implementation of these essential regulatory changes. Our expert team is available to assist with preparation, writing, and submission of post-approval applications to ensure compliance with the updated EMA guidelines.
Please feel free to reach out to Starodub for expert guidance and support.
