News - Marketing authorisation medicines for human use
44 news items Marketing authorisation medicines for human use
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 ...
Year-end withdrawals medicines for human use
Withdrawal requests for (parallel) marketing authorisations per 31 December, the so-called 'year-end withdrawals' for medicines ...
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 ...
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 ...
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 ...
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 ...