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 liaising internationally on matters relating to orphan medicinal products.
COMP members are nominated by the Member States, and are chosen on the strength of their qualifications and expertise with regard to the evaluation of medicinal products. They serve on the committee for a renewable period of three years.
The COMP is composed of:
- a chair, elected by serving COMP members;
- one member nominated by each of the 28 Member States;
- three members nominated by the European Commission to represent patients' organisations;
- three members nominated by the European Commission on the Agency's recommendation;
- one member nominated by Iceland and one by Norway.
See COMP members for the list of current members.
The 'COMP rules of procedure' provide full details of the COMP's responsibilities, composition and the roles of its members.
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