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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. -
RE: IRIS doesnt display my Products
Currently the IRIS portal shows Research Products (RPIs) and packaged medicinal products for the marketing status reports. Medicinal products-type records are not visualised in the IRIS portal for either centralised or non-centralised products. -
RE: Invoice information - Financial information tab missing
Dear Daria Mari, as mentioned in the home page of this Forum, IRIS portal users are kindly asked to refrain from creating new threads in this Forum; use the General Discussion and self-help Forum instead. -
RE: Submission and email numbering
The number at the end of the subject of the email is a token, generated automatically by the system, to route any replies to the appropriate procedure in IRIS. That number should never be removed from the subject of a reply email, to ensure appropriate routing, and is not connected to the submission/case number. That said, the system should not generate duplicate emails at completion of validation - an incident has been created to evaluate the problem. -
RE: IRIS coordinator role
The IRIS Industry coordinator role allows the older to see all submissions in the name of the relevant Organization, and to add further participants to any submission, including himself/herself, with the role of IRIS Industry Manager or IRIS Industry Contributor. Also, the coordinator can change the submission contact among the other participants in the submission (the submission contact receives all communication from IRIS procedures).
However, per se the role of IRIS Industry coordinator does not allow to edit, submit, or withdraw a submission, or to see the relevant documents; for that, an IRIS Industry Coordinator must first add himself/herself as an Industry Manager to the specific submission. In turn, this is only possible if the IRIS Industry Coordinator is affiliated to the Organization also with the role of Industry Manager.
The permissions afforded to Industry Users are finely tuned, to allow a high level of security and confidentiality even within a specific Organisation, for example to allow access for external consultants to selected submissions only. -
RE: IRIS Back-up process
Considering that IRIS is online 24/7 and that in 6 years of operation there have been no significant periods of unavailability, annual statements, signal or other IRIS-based submissions should always be sent via IRIS. -
RE: List of Submission Codes
These are internal codes for the submission category. The current list of category codes is as follows:
Submission category Prefix General EMA/GE/ i-SPOC EMA/iSPOC Marketing status EMA/PA/ Parallel Distribution EMA/PD/ PRIME EMA/PR/ Product Management EMA/PM/ Expamed EMA/EX/ Marketing Authorisation EMA/VR/ Inspections EMA/IN/ Scientific Advice EMA/SA/ Orphan Designation EMA/OD/ Paediatric procedures EMA/PE/ ITF EMA/IT/ ESMP Submission EMA/Submission Veterinary Signal Management EMA/VS/ EO-SPOC EMA/EOSPOC -
RE: Documents from the Applicant- Possibility to delete documents
As mentioned, it is only possible to delete a document if the application (submission) is in "draft" status, i.e. it has not been submitted to EMA yet. After the application has been submitted for the first time, files cannot be deleted anymore, and the dropdown button will not be visible, even if the submission has been reopened "for edit and upload or "for upload" only. In the case that your submission has never been submitted but still you cannot delete documents, please Report an issue with IRIS with our service desk, attaching screenshots and including the number of the submission. -
RE: Update active substance name & RPI
An RPI name is the concatenation of the preferred terms for each substance contained in the RPI, in alphabetical order. To change the name of an RPI it is necessary to update the name of the concerned substance(s) in SMS. You can update the name by providing the necessary information, including the substance ID, in this form: Request SMS services.
Once the substance name is updated in SMS, the RPI name will change automatically. If there is any ongoing case associated to the RPI, before the Opinion, the name of the product in the case will also change automatically, and this will be reflected in the Regulatory entitlement created or modified (if any).
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