New legislation governing the development and authorisation of medicines for use in children aged 0-17 years was introduced in the European Union in January 2007. The new piece of legislation - Regulation (EC) No 1901/2006 as amended (the 'Paediatric Regulation') - introduces sweeping changes into the regulatory environment for paediatric medicines, designed to better protect the health of children in the EU.
The Paediatric Regulation also brings in many new tasks and responsibilities for the European Medicines Agency, chief of which is the creation and operation of a Paediatric Committee within the Agency to provide objective scientific opinions on any development plan for medicines for use in children.
This section provides application information for companies or individuals wishing to develop a paediatric medicine and requiring guidance for the approval of a Paediatric InvestigationPlan (PIP) as well as information on re-examination procedures.
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Microsoft Office documents
Important note on document formats: All Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with MS Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted.
Paediatric Committee (PDCO)
Applications for PIPs are reviewed by the Agency's Paediatric Committee (PDCO)
EU Paediatric Network
See information on the EU Paediatric Network