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75 news items
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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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VMPU to start publication of GMP inspections
Starting this year, the Veterinary Medicinal Products Unit (VMPU) will publish the reports of veterinary GMP inspections. The ...
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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 ...