Committee for Orphan Medicinal Products (COMP)

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The Committee for Orphan Medicinal Products (COMP) is the committee at the European Medicines Agency that is responsible for reviewing applications from people or companies seeking 'orphan-medicinal-product designation'.

This designation is for medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. In the European Union (EU), a disease is defined as rare if it affects fewer than 5 in 10,000 people across the EU.

Composition

The members of the COMP are nominated by the EU Member States, in consultation with the Agency's Management Board. Six members are nominated by the European Commission. They are chosen on the strength of their qualifications and expertise with regard to the evaluation of medicinal products.

To represent patient organisations, the European Commission appoints three members. The European Commission also appoints three independent members on the basis of a recommendation from the Agency.

All members 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.

Meeting calendar