The regulation on medicinal products for paediatric use was adopted in October 2006 and enforced on 26 January 2007.

• Please click here to access the original texts of regulation.

New paediatric regulation will improve the health of children in Europe by:

• Facilitating the development and avalibility of medicines for children aged 0 to 17 years;
• Ensuring that medicines for use in children are of high quality, ethically researched and anthorised appropriately;
• Improving the availability of information on the use of medicines for children

     without:

• subjecting children to unnecessary trials, or,
• delaying the authorisation of medicines for use in adults.

                                                                                                               --------- EMEA - Medicines for Children, March 2008

For further information please consult: 

• The 2009 Revised Off-Patent List downloadable here.
• An amending regulation in which the texts are slightly modified from the original texts. Please click here to view the document.
• The European Paediatric Initiative: History of Paediatric Regulation. Please click here to view the document.
• Recommendation from PDCO to EU Commission on symbol, 20 December 2007. Please click here to view the document.
• Better Medicine for Children, the latest leaflet from EMEA on paediatric medicines, March 2008. Please click here to view the document.

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• FECS (now ECCO - the European CanCer Organisation)'s position paper for the consultation on Paediatric Regulation, prepared by Professor M.C.G Stevens on behalf of the SIOPE Board, 2005. Please click here to access the document.