Committee for Orphan Medicinal Products
The Committee for Orphan Medicinal Products (COMP) is responsible for reviewing applications from persons or companies seeking ‘orphan medicinal product designation’ for products they intend to develop for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10.000 persons in the European Union.
The COMP is also responsible for advising the European Commission on the establishment and development of a policy on orphan medicinal products in the EU, and assists the Commission in drawing up detailed guidelines and liasing internationally on matters relating to orphan medicinal products.
The meeting involves the participation of representatives from the National Competent Authorities (NCA’s), including European Economic Area Competent Authorities (Iceland, Norway and Liechtenstein), the European Commission and the European Medicines Agency.
The COMP holds monthly meetings, except for the month of August, at the premises of the European Medicines Agency, based in London. Informal meetings can be organized by the Member State holding the Presidency of the Council of the European Union.
An informal meeting of the COMP will be held on 30 September – 01 October (Antwerp) during the Belgian Presidency. Joint meetings with the Committee for Orphan Medicinal Products for Human Use, the Paediatric Committee, the Committee for Advanced Therapies and the Scientific Advice Working Party are foreseen.