Criteria for obtaining scientific advice
Providing scientific advice is one of the MEB's statutory tasks. The MEB strives to do everything within its capabilities to honour the requests for advice.
Considerations for the acceptance or rejection of an application for scientific advice:
A controversial question or a new subject can be referred for European advice via the European Medicines Agency (EMA).
As a rule, a request will not be honoured if an application for advice or authorisation has already been submitted to the EMA.
For a product linked to the Mutual recognition procedure (MRP) or the Decentralised procedure (DCP), the MEB will only provide advice if the Netherlands is the Reference Member State (NL = RMS). Exception: following a specific request from another RMS, the MEB can consider a request for advice in a MRP or DCP where NL = CMS. The same applies to centralised procedures where another country has already been appointed as Rapporteur or Co-Rapporteur.
Questions can be related to chemical-pharmaceutical matters, pre-clinical matters, clinical matters and/or in the field of pharmacovigilance (pre-authorisation, for example Risk Management Plans and post-marketing).
In addition, they should be:
related to the future development of the product within the requested indication, OR
related to the authorisation dossier (data package), the authorisation route to be followed and the role that the MEB could play in the authorisation phase.
The MEB provides scientific advice about products that could still be or become the subject of clinical studies. The MEB will not under any circumstances provide a judgement about the possible (contextual) evaluation of these studies by the competent medical ethics committee with respect to the medical research involving the human subjects act (WMO).
Requests for scientific advice about generic medicines will be accepted for evaluation up until two years before the dossier protection expires.