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
Assessment criteria for combination packages policy established
The Medicines Evaluation Board (MEB) has described the terms and conditions which are to be used to assess applications for...
New legal EudraVigilance obligations as of 22 November 2017
As of 22 November 2017 new obligations in respect of signal management and reporting of suspected adverse reactions (ADRs) will...
MEB starts technical validation of electronic submissions as from 1 June 2017
Submissions concerning human medicinal products must be submitted electronically to the Medicines Evaluation Board (MEB). As...
Confirmation of names for influenza strains
The Medicines Evaluation Board (MEB) has confirmed the Dutch translation for the active substances for influenza strains for...
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...