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RE: Access was granted but not able to see application
For problems and technical issues about IRIS, please create an incident ticket in EMA ServiceNow, attaching relevant screenshots for a faster response. -
RE: New Fee REGULATION (EU) 2024/568 - Fee change also apply if you submit the MAA earlier?
Please consult the information available in the EMA website, which includes a Q&A document: New Fee Regulation (from 1 January 2025) | European Medicines Agency (EMA). If you have remaining doubts, please submit your request via AskEMA: Send a question to the European Medicines Agency | European Medicines Agency (EMA). -
RE: UK (Northern Ireland) Entries - Windsor Framework
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RE: PIP contact person change
If you are referring to the procedure to change the "portal contact" (a.k.a. "submission contact") during an ongoing procedure in IRIS (not limited to PIPs), this is described in the IRIS guide to applicants (creation of submissions) (section 2.4, page 12). There are no requirements for any documents, it is sufficient that the new "portal contact" has already been added to the submission as an IRIS Industry manager.
After conclusion of the procedure, it is not possible to change the "portal contact" anymore, however it is possible, if desired, to change the contact person of the related regulatory entitlement record (for all types of Regulatory Entitlements), directly in the IRIS portal, in page Regulatory Entitlements · IRIS. Also in this case, no documents are required. -
RE: IRIS communication in QPPV absence
As a general rule, in IRIS communication emails are sent only to the "portal contact", also known as "submission contact". It is then the responsibility of that person to set appropriate autoforward rules for emails coming from the IRIS system, or in case of prolonged absences, to change the "portal contact" (as described in the IRIS Guide for Applicants, chapter 2.4). -
RE: Discrepancies between the electronic form and the generated form for PIP waiver
Regarding the issues on the mismatch of the information regarding the mechanism of action and the therapeutic areas, please raise a ticket in ServiceNow using Report an issue with IRIS. Please make sure to include screenshots of the mismatched information e.g. in the submission webform and attach a copy of the generated Word file.
Removing any enabling technology or therapeutic areas is not possible for applicants: it is only possible to add new ones. Enabling technologies and therapeutic areas apply to the whole product and its global development, not specifically to any submission being done for a specific indication or procedure. EMA adds enabling technologies and therapeutic areas, occasionally, on the basis of information collected elsewhere on public sources or from other procedures at the Agency. If an enabling technology or therapeutic area is factually incorrect and does not apply to the whole development of the product, please a submit a request to update, with appropriate justification, via Report an issue with IRIS.
Finally: the downloaded Word form is only generated for the convenience of the applicant (and the Rapporteurs/Assessors in the National Competent authority). It is not needed nor possible to reupload an edited version of the form. Any change to the information provided needs to be done via the webforms. -
RE: Discrepancies in PIP Annual Report Submission
Unfortunately it is not possible to provide an estimated timeline. The bug is likely to be assigned a medium to low priority, since it does not prevent in any way the correct submission and processing of the annual reports on deferred measures. The Word form is simply a download of the structured data in the database, which are derived from the portal submission. You can therefore submit the annual reports at their normal deadline, whether the bug has been fixed or not. -
RE: Discrepancies in PIP Annual Report Submission
This appears to be a bug. The correct form for annual reports on PIP deferred measures was implemented in IRIS in August this year. A bug ticket has been raised to address this report (Bug 221890). -
RE: "Forecast for submission of the (next) Marketing Authorisation applicant" issue-PIP ANNUAL REP.
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RE: Paediatric annual report - Research product data update
The field "foreseen date of the next Marketing Authorisation application submission for this RPI" does NOT cover variations for an existing Marketing authorisation, but only new MAAs, for example a new MAA for an orphan condition when the same RPI already is linked to a "standard" (non-orphan) authorisation product, or when a generic version is developed for an existing "standard" authorisation product. If no new MAA are foreseen for the RPI in the future, then 31/12/2099 should be specified (not 21/12/2099).
The fields "foreseen legal basis of next MAA" and "foreseen eligibility basis of next MAA" should include the option to select "N/A" for these situations, this is a known bug and it is scheduled to be fixed soon; until then, please select the existing legal basis and eligibility basis.
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