Press Release: Improving children’s medicines: EU reaches final agreement

Following a proposal from the European Commission in September 2004, the European Parliament and the Council reached a final agreement on a regulation on children’s medicines. Currently, more than 50% of the medicines used to treat children in Europe have not been tested and authorised for their use. Doctors therefore have a limited choice of medicines for sick children. This will change soon. The regulation on children’s medicines agreed upon on 1 June 2006 was expected to improve the health of Europe’s children by increasing the availability of fully researched, developed and authorised medicines specifically for use in children.

• Primary Source

European Commission: PreLex: COM(2005) 599: Proposal for a Regulation … on medicinal products for paediatric use … , 29.9.04 http://ec.europa.eu/prelex/detail_dossier.cfm?CL=en&ReqId=0&DocType=COM&DocYear=2004&DocNum=0599

European Commission: DG Enterprise and Industry: Pharmaceuticals: Medicines for Children http://ec.europa.eu/enterprise/pharmaceuticals/paediatrics/index.htm

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