Paediatric-use marketing authorisations
The paediatric-use marketing authorisation (PUMA) is a dedicated marketing authorisation covering the indication(s) and appropriate formulation(s) for medicines developed exclusively for use in the paediatric population.
The PUMA was introduced by the Paediatric Regulation 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).
- Automatic access to the centralised procedure if the applicant chooses this route, even if the application falls outside of the mandatory scope of this procedure.
- 8 plus 2 years of data and market protection
- Authorisation under the same name and branding as the authorised medicine containing the same active substance, if the marketing authorisation holder is the same
- Partial fee exemption under the centralised procedure for marketing authorisation and post-authorisation activities for a year. For more information, see Fees payable to EMA
Applying for a PUMA
PUMA applications follow existing procedures for the authorisation of medicines.
PUMA applications should contain:
- the same range of supporting documentation as 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. This includes, in particular, cross-reference to data contained in the dossier of an authorised medicine, if the relevant data protection of the reference medicine has expired (in accordance with Article 14(11) of Regulation (EC) No 726/2004 or Article 10 of Directive 2001/83/EC).
- results of all studies performed and details of all information collected in compliance with a PIP;
- the PDCO opinion and corresponding EMA decision on compliance or the applicant's compliance report (in Module 1.10). For more information on compliance, see Paediatric requirements for marketing-authorisation applications.
- A risk management plan detailing measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicine.
For more information on how to apply, see Pre-submission guidance: questions and answers.