A medicinal product may only be brought onto the market in the Netherlands when it has been granted a marketing authorisation. The MEB evaluates a medicinal product on the basis of criteria as stated in the Medicines Act (Gmw) and determines the conditions for its approval onto the Dutch market.
- Prior to marketing authorisation application
- Marketing authorisation application
- Post-marketing authorisation
- Legal basis of a medicinal product
- Dossier requirements
- Technical requirements
Health Care Inspectorate (IGZ) request to marketing authorisation holders: questionnaire for pharmacovigilance
The Dutch Health Care Inspectorate (IGZ) has developed a risk model for pharmacovigilance to obtain more insight into the risks...
MEB Portal maintenance on 30 March 2017
Due to scheduled maintenance, the MEB Portal will be unavailable on Thursday 30 March 2017 from 19.00 - 22.00 CET.
Retrospective MEB eDay 2017: Change in sight
In order to respond to e-developments, it is important that the information provision by the Medicines Evaluation Board (MEB)...
Notification form medicine shortages and defects now also in English
As of today, the notification form of the Medicine shortages and defects notification centre is now also available in English....
Start of Medicine shortages and defects notification centre
Today, the Medicine shortages and defects notification centre has been launched. The notification centre is located at the...