News - Marketing authorisation medicines for human use

44 news items Marketing authorisation medicines for human use

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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

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 ...

News item | 30-12-2019 | 08:38

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 ...

News item | 24-12-2019 | 12:00

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 ...

News item | 21-11-2019 | 13:30

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 ...

News item | 14-10-2019 | 14:00

Year-end withdrawals medicines for human use

Withdrawal requests for (parallel) marketing authorisations per 31 December, the so-called 'year-end withdrawals' for medicines ...

News item | 17-09-2019 | 09:00

MEB and ZIN start pilot to accelerate access to innovative medicines

Accelerating patient access to reimbursable innovative medicines has been on the wish list of the government, patient ...

News item | 09-05-2019 | 08:00

Amended policy relating to patented indications

The Medicines Evaluation Board (MEB) will no longer publish the full product information about the active substance of generic ...

News item | 08-05-2019 | 13:00

Brexit: Notification by the European Commission/EMA/CMDh and CMDv about Brexit and EU rules for batch control of medicinal products

On 25 February 2019 the European Commission (EC) published a notice on the European rules for batch control testing of medicinal ...

News item | 05-03-2019 | 14:00

MEB fee rate change as of January 2019

The Medicines Evaluation Board (MEB) is increasing the fee rates for authorisation applications, authorisation changes and the ...

News item | 11-12-2018 | 09:00