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 ...

News item | 16-04-2021 | 09:00

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 ...

News item | 14-03-2021 | 23:00

DCP time slot application available again

The DCP time slot application is available again. Maintenance work has been completed.

News item | 27-01-2021 | 10:00

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 ...

News item | 01-09-2020 | 09:00

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, ...

News item | 08-05-2020 | 17:00

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 ...

News item | 20-04-2020 | 12:00

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 ...

News item | 31-03-2020 | 17:00

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 ...

News item | 30-03-2020 | 17:00

Changes to product information policy

The Medicines Evaluation Board (MEB) recently revised a number of policy documents for pharmaceutical companies relating to the ...

News item | 23-03-2020 | 12:00

Amended policy on DHPCs

The Medicines Evaluation Board (MEB) has amended its policy on Direct Healthcare Professional Communications (DHPCs). This ...

News item | 21-02-2020 | 12:00