BRUSSELS DISAPPOINTED BY LOW TAKE UP OF CHILDMEDICINE AUTHORISATION SYSTEM
October 1st, 2012
BY KEITH NUTHALL
THE EUROPEAN Commission has admitted being "disappointed" by the low level of take-up of a special European Union (EU) Paediatric Use Marketing Authorisation (PUMA) designed to encourage the development of medicines for children.
Introduced by the EU's paediatric regulation (EC) No 1901/2006, only one PUMA authorisation has been issued since the legislation came into force. This is despite it offering 10 years of data and market exclusivity to any new off-patent product developed exclusively for children. In a consultation report on ...
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