Article 56

Location:
Title IV, chapter 1
Source:
Eur-Lex
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;
(aa) the Pharmacovigilance Risk Assessment Committee, which shall be responsible for providing recommendations to the Committee for Medicinal Products for Human Use and the coordination group on any question relating to pharmacovigilance activities in respect of medicinal products for human use and on risk management systems and it shall be responsible for monitoring the effectiveness of those risk management systems;
(b) the Committee for Veterinary Medicinal Products set up pursuant to Article 139(1) of Regulation (EU) 2019/6;
(c) the Committee on Orphan Medicinal Products;
(d) the Committee on Herbal Medicinal Products;
(da) the Committee for Advanced Therapies;
(e) the Paediatric Committee;
(f) a Secretariat, which shall provide technical, scientific and administrative support for the Committees and ensure appropriate coordination between them, and which shall provide technical and administrative support for the coordination group and ensure appropriate coordination between it and the Committees;
(g) an Executive Director, who shall exercise the responsibilities set out in Article 64;
(h) a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.

2.   The committees referred to in points (a), (aa), (c), (d), (da) and (e) of paragraph 1 of this Article may each establish standing and temporary working parties. The committee referred to in point (a) of paragraph 1 of this Article may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which it may delegate certain tasks associated with drawing up the scientific opinions referred to in Article 5.

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 consultation with the Committee for Medicinal Products for Human Use and the Committee for Veterinary Medicinal Products, shall set up the administrative structures and procedures allowing the development of advice for undertakings, as referred to in point (n) of Article 57(1), including advice on the use of novel methodologies and tools in research and development, particularly regarding the development of new therapies.

Those committees shall each 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 Veterinary Medicinal Products may, if they consider it appropriate, seek guidance on important questions of a general scientific or ethical nature.