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News
Previous news can be found here
17-05-2024
New Paediatric submissions are mandatory via IRIS platform from 4 June 2024
Please note that from 4 June 2024, the following types of new paediatric submissions must be carried out via IRIS:
- 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.
To ensure a smooth transition to using the IRIS platform, it is essential that applicants prepare well in advance, including registering for IRIS, as described in the following document:
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-registration-and-rpis_en.pdf
The gateway is open for ongoing paediatric procedures only.
26-04-2024
Paediatric submissions to launch on IRIS platform from 4 June 2024
Please note that from 4 June 2024, the following types of paediatric submissions must be carried out via IRIS:
- 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.
For more information please see the announcement.
Paediatric submissions
eSubmission is mandatory for all paediatric applications including new submissions and updates at any time.
Before submission an XML delivery file must be created and included in the submission package. It is important that the guidance is followed step by step.
First, follow the links and guidance below (sections 12 and 14) to create an XML delivery file in:
Delivery file UI
Then follow the guidance below for eSubmission in:
Syncplicity Web Client
- How to send submissions via the Web Client - User Guidance
This document also contains VERY IMPORTANT information on how to register or re-set a password.
Under the section Viewing sent submission receipts and acknowledgements you can find an explanation on how to access the Web Client's Inbox to ensure that your submission has been successful.
Further content about paediatric applications (what to submit, when, templates etc...):
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