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1. A Committee for Veterinary Medicinal Products (‘the Committee’) is hereby set up within the Agency.

2. The Executive Director of the Agency or his or her representative and representatives of the Commission shall be entitled to attend all meetings of the Committee, working parties and scientific advisory groups.

3. The Committee may establish standing and temporary working parties. The Committee may establish scientific advisory groups in connection with the evaluation of specific types of veterinary medicinal products, to which the Committee may delegate certain tasks associated with drawing up the scientific opinions referred to in point (b) of Article 141(1).

4. The Committee shall establish a standing working party with the sole remit of providing scientific advice to undertakings. The Executive Director, in consultation with the Committee 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) of Regulation (EC) No 726/2004, particularly regarding the development of novel therapy veterinary medicinal products.

5. The Committee shall establish a standing working party for pharmacovigilance with a remit including evaluating potential signals in pharmacovigilance arising from the Union pharmacovigilance system, proposing the options for risk management referred to in Article 79 to the Committee and to the coordination group, and coordinating the communication about pharmacovigilance between the competent authorities and the Agency.

6. The Committee shall establish its own rules of procedure. Those rules shall, in particular, lay down:

(a) procedures for appointing and replacing the Chair;

(b) the appointment of members of any working parties or scientific advisory groups on the basis of the lists of accredited experts referred to in the second subparagraph of Article 62(2) of Regulation (EC) No 726/2004 and procedures for consultation of working parties and scientific advisory groups;

(c) a procedure for urgent adoption of opinions, particularly in relation to the provisions of this Regulation on market surveillance and pharmacovigilance. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency.

7. The Secretariat of the Agency shall provide technical, scientific and administrative support for the Committee, and shall ensure consistency and quality of opinions of the Committee and appropriate coordination between the Committee and other committees of the Agency referred to in Article 56 of Regulation (EC) No 726/2004 and the coordination group.

8. The opinions of the Committee shall be publicly accessible.