legislation & guidelines
statutory tasks and the
independence of the Medicines Evaluation Board are regulated by
the General Administrative Law Act (Awb), the Medicines Act (GW)
and by EU directives (EURDIR).
In the evaluation of medicinal products, the MEB follows national
and European recommendations. On the right side of this page
you can find more information on these guidelines and
The website of the EMA and the
European Commission contain European guidelines,
adopted by the CHMP and the European Commission.
The MEB has drawn up a number of advisory documents and
guidelines which present the position of the MEB with regard to
various aspects of the authorisation of medicinal products.