News - Marketing authorisation medicines for human use
36 news items Marketing authorisation medicines for human use
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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 ...
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 ...
DCP time slot application available again
The DCP time slot application is available again. Maintenance work has been completed.
Year-end withdrawals medicines for human use
Requests to withdraw marketing authorisations and parallel import marketing authorisations as of 31 December 2020, the so-called ...
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, ...
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 ...
Request to take over the Fucidin marketing authorisation
The company Leo Pharma B.V. has informed the Medicines Evaluation Board (MEB) that the production of the antibiotic Fucidin ...
Request to take over the pyridoxine hydrochloride marketing authorisation
The company Pharmachemie B.V. has requested the Medicines Evaluation Board (MEB) to withdraw marketing authorisation for ...
Changes to product information policy
The Medicines Evaluation Board (MEB) recently revised a number of policy documents for pharmaceutical companies relating to the ...
Amended policy on DHPCs
The Medicines Evaluation Board (MEB) has amended its policy on Direct Healthcare Professional Communications (DHPCs). This ...