legislation & guidelines

The 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 conditions. 

European recommendations

The website of the European Medicines Agency and the European Commission contain European guidelines, adopted by the CHMP and the European Commission.

National recommendations

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.

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