Paediatric medicines: applications and procedures

Advice for applicants for paediatric medicines, including information on how to submit their applications, what templates and forms to use, the deadlines they need to meet, and the contact points they can reach out to.
Human Paediatrics Research and development

Update 08/08/2025:
'How to submit paediatric applications' section

How to submit paediatric applications

 IRIS platform is mandatory to be used for the following types of procedure:

  • Initial paediatric investigation plan (PIP) and the response to PDCO request for supplementary information and modification of proposed PIP (RSI following clock-stop)
  • Modification of an agreed PIP
  • Product-specific waiver
  • Compliance check
  • Annual report on paediatric deferred measures
  • Confirmation of applicability of a class waiver, or inclusion of an indication within a condition
  • Discontinuation of paediatric development.

Further guidance on the use of the IRIS platform and how to prepare submissions is available on the dedicated IRIS website:

The Paediatric Medicines Office has published new templates that must be used according to the following submission deadlines:

  • By 11 August 2025 – Use of the new templates is preferable
  • By 8 September 2025 – Use of the new templates is mandatory
  • Scientific document can be accepted until the end of 2025 in cases where it has already been drafted

The following templates have been revised:

Note: Key elements must be submitted in Word format using the designated template; only a high-level entry in IRIS is necessary (see details in the form).

To support a more consistent and guided approach, the following new templates have been introduced:

Note: RSI (formerly known as RfM) stands for ‘Paediatric Committee request for supplementary information and modification of proposed PIP

Further guidance on requested documents and other details refer to the section “Procedural advice on paediatric applications”.

Procedural advice on paediatric applications

Procedural advice on paediatric applications can be found on the IRIS platform and on our Q&A page:

In addition applicants should consult the procedural advice document below:

Pre-submission interactions

The Paediatric Medicines Office offers scientific and regulatory pre-submission PIP interactions in situations where guidance is needed, on a case-by-case basis. Please see: 

Submission deadlines

Applicants should check the submission deadlines for paediatric procedures for the 2024-2026 period: 

Templates and forms

The relevant templates and forms are available at below.

Please make sure to first download and save the forms and templates before filling them out. 

Please also use the latest published version of all templates and forms unless stated otherwise. Do not re-use previously-downloaded documents

To report any technical issues with the form, contact the EMA Service Desk.

See also:

Contact points

To contact EMA, please see the options via the link below: 

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