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Regulatory Science Magazine 10: Reduction, replacement and refinement of animal studies
This week, the newest edition of the Regulatory Science Magazine was issued. This 10th edition of the online science magazine of ...
Amended policy on DHPCs
The Medicines Evaluation Board (MEB) has amended its policy on Direct Healthcare Professional Communications (DHPCs). This ...
Citrix systems back online
The MEB Citrix systems have been put back into use. The safety patches for the Citrix systems have been installed and operations ...
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 ...