Committee for Orphan Medicinal Products
Article 4
1
A Committee for Orphan Medicinal Products, hereinafter referred to as ‘the Committee’, is hereby set up within the Agency.
2
The task of the Committee shall be:
a
to examine any application for the designation of a medicinal product as an orphan medicinal product which is submitted to it in accordance with this Regulation;
b
to advise the Commission on the establishment and development of a policy on orphan medicinal products for the European Union;
c
to assist the Commission in liaising internationally on matters relating to orphan medicinal products, and in liaising with patient support groups;
d
to assist the Commission in drawing up detailed guidelines.
3
The Committee shall consist of one member nominated by each Member State, three members nominated by the Commission to represent patients' organisations and three members nominated by the Commission on the basis of a recommendation from the Agency. The members of the Committee shall be appointed for a term of three years, which shall be renewable. They may be accompanied by experts.
4
The Committee shall elect its Chairman for a term of three years, renewable once.
5
The representatives of the Commission and the Executive Director of the Agency or his representative may attend all meetings of the Committee.
6
The Agency shall provide the secretariat of the Committee.
7
Members of the Committee shall be required, even after their duties have ceased, not to disclose any information of the kind covered by the obligation of professional secrecy.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(f) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)