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.

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:

• IRIS: A secure online platform for handling product-related scientific and regulatory procedures with EMA

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:

Template for scientific document for paediatric investigation plan or product-specific waiver

Reference Number: EMA/257294/2024 Version 3

Key elements form: Applicant’s proposal for a paediatric-investigation-plan opinion

Reference Number: EMA/283362/2012 Version 7

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:

Response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) - Re-submission following clock-stop

Additional information - Applicant’s clarifications following Paediatric Committee (PDCO) discussions or re-discussions

Reference Number: EMA/241572/2025

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:

• IRIS platform
• Paediatric investigation plans: questions and answers

In addition applicants should consult the procedural advice document below:

Procedural advice on paediatric applications

Reference Number: EMA/672643/2017 Rev. 14

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: 

• Procedural advice on paediatric applications, section on ’Pre-submission interactions’
• Paediatric investigation plans: questions and answers, questions 4 and 5

Submission deadlines

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

Submission deadlines for paediatric applications 2024-2026

Reference Number: EMA/21598/2024

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:

• Paediatric investigation plans: Templates, forms and submission dates

Template for scientific document for paediatric investigation plan or product-specific waiver

Reference Number: EMA/257294/2024 Version 3

Request for modification of an agreed paediatric investigation plan

Paediatric investigation plan (PIP) - Key elements form

Reference Number: EMA/283362/2012 Version 8

Template - Request for compliance check on an agreed paediatric investigation plan (PIP)

Notification of discontinuation of an agreed PIP decision

Response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) - Re-submission following clock-stop

Additional information - Applicant’s clarifications following Paediatric Committee (PDCO) discussions or re-discussions

Reference Number: EMA/241572/2025

Contact points

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

• Paediatric medicines: Research and development: Contact points