News - Marketing authorisation medicines for human use
49 news items Marketing authorisation medicines for human use
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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, ...
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 ...
Shorter timetable for procedure for changing parallel package leaflet
The Medicines Evaluation Board (MEB) has decided to implement a shorter timetable for the procedure for changing the parallel ...
MEB fee rate change as of January 2020
The Medicines Evaluation Board (MEB) is increasing the fee rates for authorisation applications, authorisation changes and the ...
Change for consultation procedures resulting from the implementation of Medical Device Regulation (MDR)
As of 26 May 2020 the Medicines Evaluation Board (MEB) will provide advice under the new Medical Device Regulation (MDR, EU ...
Changes to product information must be made more quickly
Within Europe agreements are regularly made regarding changes to information on medicinal products. In many cases it takes too ...