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Chapter 1 · Tasks of the Agency › Article 56

Article 56

1. The Agency shall comprise:
(a) the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use;
(b) the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use;
(c) the Committee on Orphan Medicinal Products;
(d) the Committee on Herbal Medicinal Products;
(e) a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them;
(f) an Executive Director, who shall exercise the responsibilities set out in Article 64;
(g) a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.
2. The committees referred to in paragraph 1(a) to (d) may each establish standing and temporary working parties. The committees referred to in paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Articles 5 and 30.
When establishing working parties and scientific advisory groups, the committees shall in their rules of procedures referred to in Article 61(8) provide for:
(a) the appointment of members of these working parties and scientific advisory groups on the basis of the lists of experts referred to in the second subparagraph of Article 62(2); and
(b) consultation of these working parties and scientific advisory groups.
3. The Executive Director, in close consultation with the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use, shall set up the administrative structures and procedures allowing the development of advice for undertakings, as referred to in Article 57(1)(n), particularly regarding the development of new therapies.
Each committee shall establish a standing working party with the sole remit of providing scientific advice to undertakings.
4. The Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use may, if they consider it appropriate, seek guidance on important questions of a general scientific or ethical nature.

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