The MEB places importance on the transparency of its decision-making concerning the authorisation of medicinal products, the context within which such decisions are made, and the conduct of the competent bodies and the organisation’s staff. The MEB has a public function and wishes to account for the work it performs. It is therefore essential to provide an insight into the governance and the decision-making process.

The rules governing the MEB’s functioning and the execution of its duties are set out in the administrative regulations, which entered into force on 27 September 2012.

The MEB as organisation

The MEB evaluates and monitors the efficacy and quality of human and veterinary medicines, as well as adverse reactions to such medicines. In addition, the MEB evaluates the safety of novel foods for human consumption.

From an organisational point of view, the MEB is an independent administrative body under the auspices of the central government. This means that the MEB makes independent decisions on the authorisation and monitoring of medicinal products.

The MEB comprises the following:

  • A Board which is legally authorised to issue, withdraw or suspend marketing authorisations and which continually monitors and evaluates the efficacy of and adverse reactions to medicines.
  • A secretariat whose task is to support the MEB and to prepare and carry out decision-making. These tasks are performed by the Medicines Evaluation Board Agency.
CBG model