Priority list of off-patent medicines

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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 as a basis for the 7th call of the FP7 programme (Work Programme 2013, to be published in June 2012).

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Document(s) Language Status First published Last updated Effective Date
Revised priority list for studies into off-patent paediatric medicinal products (English only)   11/09/2009 09/02/2012  

Related links

The Work Programme 2013 for the 7th Framework Programme (FP7) will be published in July 2012. For further information, please refer to:

A workshop on the funding through FP7 of studies into off-patent medicines developed for children was hosted at the European Medicines Agency on 6 June 2007. Further information can be found here.