Discrepancies between the electronic form and the generated form for PIP waiver

Dear IRIS team,

I have noticed some discrepancies between the information I provided and what is presented in the generated form for the PIP waiver.

In the research product data update:

The information included in the mechanism of action differs from what I provided.
The information in the therapeutic areas section appears to be the same as what I included in enabling technologies, rather than the correct information.

Additionally, I would like to inquire whether it is possible to remove one of the selected options in enabling technologies, as there does not seem to be an option to do so.

Due to these discrepancies, I would like to know if it is possible to download the generated form, edit it, and upload it again in the Documents from Applicant section with the correct information.

Thank you in advance.

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.