Paediatric medicines: applications and procedures
As of 4 June 2024, applicants should use the IRIS platform for the following types of procedure:
- Initial paediatric investigation plan (PIP)
- 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.
Applicants should register for IRIS and obtain a research product identifier(RPI) well in advance of their intended submission date.
An RPI is mandatory for PIP applications:
IRIS guide to registration and RPIs
Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.
English (EN) (1.32 MB - PDF)
First published: Last updated:
Further guidance on the use of the IRIS platform and how to prepare submissions is available on the dedicated IRIS website:
For ongoing applications submitted before 4 June 2024, the previous process will apply (eSubmission: Projects (europa.eu)). This includes validation issues and documents to be provided during initial assessment. PIPs in clock-stop may have a case-by-case arrangement.
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