The Management Board is the European Medicines Agency's integral governance body. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency's performance.
The Board's operational tasks range from adopting legally binding implementing rules, to setting strategic directions for scientific networks, to reporting on the use of European Union (EU) contributions for the Agency's activities:
- It has legally enforceable rule-making authority for implementation of certain parts of the fee regulation. It adopts the Agency's financial regulation and its implementing rules, which are binding texts for the Agency, the Board and the Executive Director.
- It has a key role to play in the 'discharge' (sign-off) process of the Agency's accounts by the European Union's budgetary authority. As part of this process, the Board conducts an analysis and assessment of the Executive Director's annual activity report. This forms part of the package of controls and reports that lead to Executive Director receiving discharge for the Agency's budget. The Board also gives its opinion on the Agency's annual accounts.
- It has close ties with the Agency's accounting officer, who is appointed by the Board, and with the internal auditor, who reports to the Board and to the Executive Director on audit findings.
- It is consulted on the rules of procedure and the membership of the Agency's committees.
- It is responsible for adopting the implementing provisions for the practical application of the rules and regulations applicable to officials and other EU staff.
The tasks and responsibilities of the Management Board are set out in the Agency's legal background.
The members of the Management Board are appointed on the basis of their expertise in management and, if appropriate, experience in the field of human or veterinary medicines. They are selected to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographical spread within the EU.
The Management Board is made up of the following members:
- one representative of each of the EU Member States;
- two representatives of the European Commission;
- two representatives of the European Parliament;
- two representatives of patients' organisations;
- one representative of doctors' organisations;
- one representative of veterinarians' organisations.
In addition to the members, the Management Board also has one observer each from Iceland, Liechtenstein and Norway.
The representatives of the Member States, European Commission and European Parliament are appointed directly by the Member State and institution concerned. The four 'civil society' Board members (patients', doctors' and veterinarians' representatives) are appointed by the Council of the European Union, after consultation of the European Parliament.
The representatives of the Member States and of the Commission may have alternates.
Board members are appointed for a three-year term, which may be renewed.