European Medicines Agency - Human Medicines - Medicines for children - Priority list of off-patent medicines

Medicines for children
Paediatric-related information
Priority list of off-patent medicines

Thanks to the Paediatric Regulation, funding of studies into off-patent medicinal products (i.e. those not covered by a patent or supplementary protection certificate) is available. This funding, provided through the EU Framework Programmes, should cover the development of off-patent medicinal products with a view to the submission of an application for a paediatric-use marketing authorisation.

In order to ensure that funds are directed into research of medicinal products with the highest need in the paediatric population, the PDCO has revised and, after public consultation, adopted the following priority list of off-patent products for which studies are required:

Priority list for studies into off-patent paediatric medicinal products (EMEA/414936/2009) Updated 03/07/09 Updated on jueves, 16 de julio de 2009
For further information on how to apply to the 3rd call of the 7th Framework Programme for off-patent medicines developed for children, please refer to:

FP7 Cooperation Work Programme: Health (on the Cordis website).
A workshop on the funding through FP7 of studies into off-patent medicines developed for children was hosted at the EMEA on 6 June 2007. Further information can be found under 'Workshops'.

abrir aquí para acceder al documento general EMEA y desde allí a sus secciones:
European Medicines Agency - Human Medicines - Medicines for children - Priority list of off-patent medicines