Article 52

1. The Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products shall each consist of two members nominated by each Member State for a term of three years which shall be renewable. They shall be chosen by reason of their role and experience in the evaluation of medicinal products for human and veterinary use as appropriate and shall represent their competent authorities. The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the Committees, their working parties and expert groups. Members of each Committee may arrange to be accompanied by experts. 2. In addition to their task of providing objective scientific opinions to the Community and Member States on the questions which are referred to them, the members of each Committee shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent national authorities, including the consultative bodies concerned with the marketing authorization. 3. The members of the Committees and the experts responsible for evaluating medicinal products shall rely on the scientific assessment and resources available to the national marketing authorization bodies. Each Member State shall monitor the scientific level of the evaluation carried out and supervise the activities of members of the Committees and the experts it nominates, but shall refrain from giving them any instruction which is incompatible with the tasks incumbent upon them. 4. When preparing the opinion, each Committee shall use its best endeavours to reach a scientific consensus. If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and may, at the request of those concerned, include the divergent positions with their grounds.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.