The European Pharmacopoeia (Ph. Eur.) Commission is the decision-making body of the European Pharmacopoeia and is responsible for the elaboration and maintenance of its content. The Ph. Eur. Commission adopts all the texts to be published in the Ph. Eur. and takes technical decisions by consensus.
The Ph. Eur. Commission
- evaluates proposals for inclusion, revision or suppression of monographs and general chapters,
- allocates agreed work items to a Group of Experts or Working Party,
- reviews overall progress made on the work programme, including revision work, on a yearly basis,
- approves the terms of reference of Groups of Experts and Working Parties, defines criteria to be applied for the selection of experts and ad hoc specialists and appoints them.
Composition of the Ph. Eur. Commission
The Commission is composed of the delegations representing the contracting parties to the Convention on the Elaboration of a European Pharmacopoeia, currently 39 member states and the European Union (EU).
The up to three members of delegations are appointed by the Contracting Party based on their experience and competence in matters dealt with by the Commission. Each Contracting party can also appoint up to three similarly-qualified alternates.
Observers can take part in the scientific work of the European Pharmacopoeia Commission and benefit from European experience in this area.
According to its Rules of procedure, the European Pharmacopoeia Commission may, by a unanimous vote of the delegations casting a vote admit technically qualified observers, such as:
- observers from Member States of the Council of Europe that are not parties to the Convention;
- observers from States that are not Members of the Council of Europe;
- observers from international governmental organisations;
- observers from international non-governmental organisations.
Sessions of the Commission
The Commission meets three times a year (usually in March, June and November) at the EDQM premises in Strasbourg. Sessions are held in private.
Ph. Eur. Commission sessions are attended by the delegations of the contracting parties. Observers to the Ph. Eur. Commission (see above) are also always welcome.