COMP report to the Commission in relation to article 10 of Regulation 141/2000 on orphan medical products

The European Medicines Agency's Committee on Orphan Medicinal Products (COMP), on 5 August 2005, published a report on its experience to date with the EU legislation on orphan medicinal products adopted in April 2000. The report highlights the success of the legislation - in particular the public health benefits that have resulted for patients suffering from rare diseases - while also identifying areas where the EU policy on orphan medicines could be strengthened. Please click on the first Related Url for the Annexes to this report.

• Primary Source

European Medicines Agency: COMP: General reporting http://www.emea.europa.eu/htms/human/comp/compgen.htm

European Medicines Agency: Orphan medicinal product designation in the European Union: Leaflet, 2003 http://www.emea.europa.eu/pdfs/human/comp/leaflet/661801En.pdf

---