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102 news items
MEB Citrix systems switched off
Out of precaution the MEB Citrix systems have been switched off, due to the recent Citrix safety warnings. As a result, MEB ...
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 ...
Regulatory Science Magazine 9: opioids and Real World Data
Today the Medicines Evaluation Board (MEB) publishes the 9th edition of its Regulatory Science Magazine. This edition features ...
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 ...
8th edition Regulatory Science Magazine
Today the Medicine Evaluation Board (MEB) publishes the 8th edition of its Regulatory Science Magazine. This edition focuses on ...
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 ...