News - Marketing authorisation medicines for human use
25 news items Marketing authorisation medicines for human use
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MEB fee rate change as of January 2022
The Medicines Evaluation Board (MEB) increases the fee rates for authorisation applications, authorisation changes and the annual ...
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Changes to policy on product information
The Medicines Evaluation Board (MEB) has recently revised two policy documents for pharmaceutical companies in respect of the ...
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New reporting process for the Medicine Shortages and Defects Notification Centre
With effect from 1 January 2022, the Medicines Evaluation Board and the Health and Youth Care Inspectorate will be introducing ...
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Medicine shortages and defects notification centre form improved
The notification form of the Medicine Shortages and Defects Notification Centre has been made more user-friendly. Various ...
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Year-end withdrawals medicines for human use
Requests to withdraw marketing authorisations and parallel import marketing authorisations as of 31 December 2021, the so-called ...
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Medical Devices Regulation: additional information about the procedure for medical devices
The date of application of the Medical Devices Regulation (MDR, EU 2017/745) is getting closer. In order to estimate the workload ...
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MEB advises to put AstraZeneca vaccination temporarily on hold
The Medicines Evaluation Board (MEB) has advised Minister De Jonge of Health, Welfare and Sport (VWS) to consider to put the ...
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DCP time slot application available again
The DCP time slot application is available again. Maintenance work has been completed.
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Implementation of the Medical Device Regulation postponed until 26 May 2021
Due to the coronavirus crisis the European Commission has postponed the implementation of the new Medical Device Regulation (MDR, ...
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MEB Portal shut down permanently
For safety reasons, the MEB portal was provisionally taken offline in January this year. Unfortunately, the MEB has had to take ...