scientific advice
The evaluation and monitoring of medicinal
products is based on knowledge about the many properties of a
medicine, which can be defined as a product manufactured from a
pharmacologically active substance. This knowledge is developed
within:
- industry
- academic institutions
- and clinical practice
The MEB uses this knowledge in order to make a final
assessment
on the licensing of the medicine and the conditions under which it
may be used and then passes this accumulated knowledge on to
decisionmakers and users. The ultimate aim of this process is to
promote the careful use of medicines. One of our strategic priorities is to strengthen the
MEB as a link and partner in this continuum of pharmaceutical
knowledge.
What kind of advices are provided by the MEB?
During the development of a medicinal product, advice can be
requested from the MEB. This also applies for medicated
medical devices. A request for advice may be submitted to the MEB
not only during the development phase but also immediately before
the actual submission of the marketing authorisation application.
The advice can be related to the scientific content of the
dossier or the authorisation procedure to be followed.
The advice is given on the basis of current scientific knowledge
and in accordance with the prevailing guidelines. It cannot be
seen to be predictive of the final opinion of the MEB and/or the
CHMP following assessment of the entire dossier. The MEB will of
course treat all data it receives in confidence.
Regulatory advice relates mainly to questions on the legal
basis of an application. This can sometimes be given together with
scientific advice, and sometimes separately.
Visit
regulatory affairs > products & fees for an overview of
costs regarding to scientific advice.
Questions?
For general matters please contact our scientific advice
programme desk at 0031 (0)70 -356 7519, email: pb.wetenschap@cbg-meb.nl. For
questions about the procedure or planning, please send an email to:
case@cbg-meb.nl (add the case number
in the subject line: case number [number]).
Does your question relate to an application that is currently in
process, please submit it to the following e-mail address:
case@cbg-meb.nl.
In the subject line the case number should be stated in the
format: case number [number].
More informatie
Medical devices