Paediatric medicines: applications and procedures

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

• Initial paediatric investigation plan (PIP) and responses to PDCO request for modification (PIPs on 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

In case PIPs in clock-stop are not yet available in IRIS, please contact us via IRIS Stakeholder Forums.

Further guidance on requested documents and other details refer to the paragraph “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:

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

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

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

• Paediatric medicines: Research and development: Contact points