Paediatric-use marketing authorisation (PUMA) is a type of marketing authorisation covering the indication(s) and appropriate formulation(s) for the paediatric population, which was introduced by the Paediatric Regulation.
Applicants can request PUMAs for medicines that are:
- already authorised;
- no longer covered by a supplementary protection certificate (SPC) or a patent that qualifies as a SPC;
- to be exclusively developed for use in children.
The development of a PUMA must follow a paediatric investigation plan (PIP), to be agreed by the Paediatric Committee (PDCO).
A PUMA will benefit from 10 years of market protection as a reward for the development in children.
Applying for a PUMA
PUMA applications should contain the same range of supporting documentation as for other marketing-authorisation applications, with a combination of new data or existing data. Depending on the legal basis for the application, literature and cross-references to other medicines' dossiers can be used. In particular, cross-reference to the data contained in the dossier of an authorised medicine is possible, in accordance with Article 14(11) of Regulation (EC) No 726/2004 or Article 10 of Directive 2001/83/EC, if the relevant data protection of the reference medicinal product has expired.
Information on how to apply is available in Presubmission guidance: questions and answers.
A PUMA application has to contain the results of all measures performed and details of all information collected in compliance with an agreed PIP. The application should include the corresponding European Medicines Agency decision as well as the PDCO opinion on compliance or the applicant’s compliance report. For more information on compliance, see Paediatric requirements for marketing-authorisation applications.
Applicants are required to detail the measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product in a risk-management plan submitted with the PUMA application.
For more information, see:
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- Better medicines for children (2015-05-18)