Article 53

1. Where, in accordance with the provisions of this Regulation, the Committee for Proprietary Medicinal Products or the Committee for Veterinary Medicinal Products is required to evaluate a medicinal product, the Committee shall appoint one of its members to act as rapporteur for the coordination of the evaluation, taking into consideration any proposal from the applicant for the choice of a rapporteur. The Committee may appoint a second member to act as co-rapporteur. The Committee shall ensure that all its members undertake the role of rapporteur or co-rapporteur. 2. Member States shall transmit to the Agency a list of experts with proven experience in the assessment of medicinal products who would be available to serve on working parties or expert groups of the Committee for Proprietary Medicinal Products or the Committee for Veterinary Medicinal Products, together with an indication of their qualifications and specific areas of expertise. This list shall be updated as necessary. 3. The provision of services by rapporteurs or experts shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and his employer. The person concerned, or his employer, shall be remunerated in accordance with a fixed scale of fees to be included in the financial arrangements established by the Management Board. 4. On a proposal from the Committee for Proprietary Medicinal Products or the Committee for Veterinary Medicinal Products, the Agency may also avail itself of the services of rapporteurs or experts for the discharge of other specific responsibilities of the Agency.

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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.