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statutory tasks

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 summary, the statutory tasks of the Board are:

  • Deciding on marketing authorisations (granting, changing, suspending, withdrawing) including determination of the legal status of supply.
  • Pharmacovigilance.
  • If requested providing scientific advice for the purposes of requesting marketing authorisation.
  • If requested providing advice on the medicinal product component of a medical device.
  • Entering clinical trials into the European database upon request of the CCMO.

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