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Advice on implementing regulation (EU) 2024/1159
The European Medicines Agency (EMA) published a new version of the QRD template in November 2024: QRD template version ...
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Science Policy 2025–2029: From expertise to impact
The MEB has a new Science Policy for 2025-2029. Four key themes will guide regulatory science at the MEB for the coming four ...
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Planning tool for requesting time slots mandatory from 1 July 2025
As of 1 July 2025 it will be mandatory to use the MEB planning tool to reserve a time slot for submitting an application for ...
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MEB Science Day 2025 - Platform Technologies: opportunities and challenges
Join us for the MEB Science Day 2025, a unique opportunity to share knowledge and connect with colleagues in the field of ...
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New veterinary QRD template version 9.1 published
A Summary of Product Characteristics (SPC), a label and a package leaflet are established when a marketing authorisation is ...
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European Shortages Monitoring Platform operational
The European Shortages Monitoring Platform (ESMP) went live this week. The platform enables marketing authorisation holders and ...
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MEB fee rate change as of January 2025
The Medicines Evaluation Board (MEB) increases the fee rates for authorisation applications, authorisation changes and the annual ...
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New Veterinary Medicinal Products Unit fees for 2025
With effect from 1 January 2025, the Medicines Evaluation Board (MEB) will be increasing its fees. This increase is necessary due ...
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Revised notification form for medicine shortages and defects
The notification form of the Medicine Shortages and Defects Notification Centre has been made more user-friendly. The marketing ...
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MEB Science Day 2024: Human centric approaches to improve the success of oncology therapies
The MEB Science Day 2024 took place in the Princess Máxima Center for Pediatric Oncology in Utrecht on 16 April 2024 and focused ...