Rewards and incentives for paediatric medicines in European Union

Published by EMA

RewardPaediatric IncentiveMarket Exclusivity

This guide provides some rewards and incentives to encourage investment in research and development of medicines for children in European Union. E.g Peadiatric medicinces once they receive a marketing authorisation, they benifit additional 6 months of market exclusivity regardless patent expiration. Medicines once approved for children that are not protected by a patent or supplementary protection certificate are eligible for a paediatric-use marketing authorisation (PUMA). If a PUMA is granted, the product will benefit from 10 years of market protection.

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