[Better medicines for children: European measures].
The Paediatric Regulation has been in force in the EU since 1 July 2007. This has changed the procedure for obtaining marketing authorisation of medicines in Europe so that new medications can be adapted safely for use in children. Additional provisions have been made for the use of authorised and generic medications in children. Research is being stimulated through subsidies and the extension of exclusive distribution rights for manufacturers. Other initiatives are aimed at making existing data on the use of medications in children accessible. Many of these tasks are the responsibility of a special European paediatric committee, which also assesses proposals for research on medication use in children.
van den Berg
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Agentschap College ter Beoordeling Geneesmiddelen, Postbus 16.229, 2500 BE Den Haag. h.vd.berg@cbg-meb.nl
Taminiau
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JA
D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D002648:Child; D015507:Drugs, Investigational; D005062:European Union; D006801:Humans; D007880:Legislation, Drug
D015507:Drugs, Investigational