EMA call to patient organisations for the Committee for Orphan Medicinal Products (COMP)

EMA uissued a call to patient organisations to apply and be part of the EMA Committee for Orphan Medicinal Products (COMP), in the context of the Orphan Medicines Regulation. The deadline for submission of applications is 1 December 2014. More information
  • Online link: http://ec.europa.eu/health/human-use/orphan-medicines/developments/index_en.htm
  • Call target: Patient representatives
  • Basis legislation: EU Regulation 141/2000 on orphan medicinal products laying down specific rules concerning the criteria and procedure for the designation of an orphan medicinal product. According to Article 4(3) of the Regulation the COMP shall include "three members nominated by the Commission to represent patients' organisations". These members shall be appointed for a term of three years, which shall be renewable.
  • Main task: examine applications for the designation of a medicinal product as an orphan medicinal product which is submitted to it in accordance with the Regulation on Orphan Medicinal Products.
  • Other tasks:

-       to advise the Commission on the establishment and development of a policy on orphan medicinal products for the EU;

-       to assist the Commission in liaising internationally on matters relating to orphan medicinal products, and in liaising with patient support groups;

-       to assist the Commission in drawing up detailed guidelines