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RE: update substance name
Please consult the "IRIS guide to Registration, Substances and RPIs", available in the IRIS Portal (pages 19 to 25). -
RE: PIP Annual Report
In answer to the questions:- There is no need to provide additional documents in an annual report on PIP deferred measures. The information in the portal forms is sufficient. If the applicant desires, it is possible to provide additional documents with the submission, but this is optional.
- There can be two possible situations:
- The study has already started: please put the actual start date of the study (for clinical trials, this is usually first patient first visit)
- The study has not started yet: please put the currently planned date of start, regardless of what was agreed in the PIP (if anything).
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RE: Paediatric submissions in IRIS: one condition per submission
Current legislation does not explicitly prevent a single EMA decision from covering multiple conditions with a paediatric investigation plan and/or product-specific waiver(s), even if this may not be in the applicant's best interest. As such, if an applicant desires to modify an existing PIP regulatory entitlement covering multiple conditions, this is still possible; it is sufficient to submit the application on the basis of the existing Regulatory Entitlement. Alternatively, the applicant may decide to "split" the PIP decision beforehand. For further information on the likely consequences of each course of actions, please see the following documents available on the EMA website: -
RE: IRIS Roles from Multiple Organizations
IRIS works on a system of affiliation to organisations, which is not linked to any contractual relationship of IRIS users with any particular organisation. Affiliation is under the control of the organisations, each of which has to nominate an initial "Admin User", in charge of allowing future affiliations. In this particular case, you can be added to the submission as a contributor or manager for that submission if you are also affiliated to the CRO in question, with an IRIS role, in addition to the company where you already have an IRIS affiliation and role. -
RE: PIP waiver application
No. Once an application has been drafted, it is not possible to change the location of the applicant, or the process type. It is necessary to create a new submission. -
RE: General questions about IRIS
Submissions and related documents are only deleted automatically if the submission has remained in the "draft" stage for more than 7 months, i.e. it has never been submitted, without modifications even after a notification is sent by the system. Once an application is submitted, data and documents are retained for the period required by legislation, whether the procedure is completed or also if the submission is withdrawn before finalisation.
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RE: Contact detail change
For specific issues such as this one, please Report an issue with IRIS. -
RE: IRIS coordinator role
The differences among the different IRIS roles for Industry are described in the IRIS Guide to Registration and RPIs (pages 14 and 15). -
RE: Purely regulatory question
The "Submission details" section of a new application is also called "Submission notes" and is one of the tabs in the main page of the submission (see attached file). -
RE: PIP Initial Submission and use of IRIS from 04 June 2024
While only one "portal contact" (submission contact) at a time is allowed in IRIS, it is possible to change the portal contact any number of times, in IRIS. For draft or ongoing submissions, this allows to replace the portal contact (the only receiver of IRIS communication) among the users associated to the submission as Industry Managers, either temporarily or permanently. This applies to any type of IRIS submissions, not just for Paediatric ones.
Please see chapter 2.4 of the IRIS Guide to applicants (creation of submissions) document for instructions.
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