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.
Human Regulatory and procedural guidance Paediatrics

The paediatric-use marketing authorisation (PUMA) applies to 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 EMA's Paediatric Committee (PDCO).

This is in line with the Paediatric Regulation. 

For more information on marketing authorisation for paediatric medicines, see:

Incentives for applicants

Applicants for a PUMA have the following incentives:  

  • 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: 

Application process

PUMA applications follow existing procedures for the authorisation of medicines.

Before a PUMA application is submitted for the centralised procedure, applicants must request an eligibility confirmation. 

To do so, applicants can submit the form below via a EMA ServiceNow ticket: 

To open the form below, you need a PDF reader. First save the document using your browser functionality. Then open the document with a PDF reader, such as Acrobat Reader.

Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application

English (EN) (5.19 MB - PDF)

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How to apply

Applicants should go through the following steps:

  • Selecting the tab “Business Services”, category “Human Regulatory”
  • Select the subcategory “Pre-Submission Phase - Human”
  • Select the sub-option “Eligibility Request”

If you do not have an EMA Account, please create it via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance "Create an EMA Account".

What applications should contain 

PUMA applications should contain:

  • the same range of supporting documentation as other marketing-authorisation applications, with a combination of new and existing data;
  • 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)
  • 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.

Depending on the legal basis for the application, literature and cross-references to other medicines' dossiers can be used as supporting documentation. 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. This is in accordance with Article 14(11) of Regulation (EC) No 726/2004 or Article 10 of Directive 2001/83/EC.

For more information, see:

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