Rewards and incentives for paediatric medicines

Several rewards and incentives for the development of paediatric medicines for children are available in the European Union (EU).

• Medicines authorised across the EU with the results of studies from a paediatric investigation plan included in the product information are eligible for an extension of their supplementary protection certificate by six months. This is the case even when the studies' results are negative.
• For orphan medicines, the incentive is an additional two years of market exclusivity.
• Scientific advice and protocol assistance at the Agency are free of charge for questions relating to the development of paediatric medicines.
• Medicines developed specifically for children that are already authorised but 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 as an incentive.

The above can be complemented by other incentives to support the research, development and availability of medicinal products for paediatric use. Information on national rewards and incentives for paediatric medicines is available in this document:

• Inventory of Community and Member State rewards and incentives to support research into, and the development and availability of, medicinal products for paediatric use

For more information on paediatric rewards, see:

• Questions and answers on the procedure of PIP compliance verification at EMA, and on paediatric rewards

Marketing-authorisation holders benefitting from rewards and incentives

Information on companies who have benefitted from paediatric rewards and incentives is available in annual reports to the European Commission:

• Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this regulation: Year 2018 (new)
• Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this regulation: Year 2017
• Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this regulation: Year 2016
• Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this regulation: Year 2015
• Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this Regulation: Year 2014
• Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this Regulation: Year 2013
• Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this Regulation: Year 2012
• Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this Regulation, covering the year 2011
• Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this Regulation, covering the year 2010
• Report to the European Commission: Companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and the companies that have failed to comply with any of the obligations in this Regulation covering the years 2007 to 2009