Paediatric-use marketing authorisations (PUMAs)

The paediatric-use marketing authorisation is a new type of marketing authorisation. It may be requested for a medicine which is already authorised, but no longer covered by intellectual property rights (patent, supplementary protection certificate), and which will be exclusively developed for use in children.

This type of marketing authorisation will cover the indication and appropriate formulation for the paediatric population. The development of this medicine in children will follow a paediatric investigation plan (PIP). This PIP, which must discuss all paediatric subsets, will have to be agreed by the Paediatric Committee. A paediatric-use marketing authorisation will benefit from 10 years of market protection as a reward for the development in children.