News - Marketing authorisation medicines for human use

18 news items Marketing authorisation medicines for human use

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Amended policy on national implementation of additional risk minimisation measures

The Medicines Evaluation Board (MEB) has amended its policy for the national implementation of additional risk minimisation ...

News item | 30-03-2022 | 15:00

Medicines available faster due to simultaneous assessment

The National Health Care Institute joined forces with the Medicines Evaluation Board to develop a method that would give patients ...

News item | 22-02-2022 | 10:00

Improvements to the notification process and form now available

In December 2021 the Medicines Evaluation Board and the Health and Youth Care Inspectorate announced the introduction of changes ...

News item | 21-01-2022 | 17:00

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 ...

News item | 03-01-2022 | 10:00

Changes to policy on product information

The Medicines Evaluation Board (MEB) has recently revised two policy documents for pharmaceutical companies in respect of the ...

News item | 16-12-2021 | 10:00

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 ...

News item | 01-12-2021 | 10:00

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 ...

News item | 01-10-2021 | 13:00

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 ...

News item | 24-09-2021 | 13:00

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

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