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RE: Inspection notifications - Case numbers vs Submission number
As mentioned in the previous answer, the case number is identical to the submission number, for cases with a single product. GMP Inspections however have more than one submission per case, and in that situation the case number is different from all the submission numbers. Applicants may always make reference to the submission number, as this is always related to a case, once the application has been submitted. The case number is not currently displayed in IRIS. Please raise a ServiceDesk ticket to request the inclusion of the case number in the IRIS portal, for GMP cases, or alternatively the inclusion of the submission number in the notification received. -
Transferring a Marketing Authorisation does not transfer the corresponding RPI
Please note that at the conclusion of a procedure of transfer of Marketing Authorisation, only the Authorisation Product is transferred to the new Marketing Authorisation Holder, but not the parent RPI of the Authorisation product. The owners of the RPI and of the child Authorisation Products do not need to be the same. To transfer the RPI, a specific procedure exists in IRIS; the procedure is completely automated, as it does not require an EMA Opinion or EC decision, and is completed in a few minutes. -
RE: PIP modification - limited number of characters for adult indication
Please report this type of issues and requests via the EMA Servicedesk platform: Report an issue with IRIS. -
RE: Documents from the Applicant- Possibility to delete documents
Please see the attached screenshot -
RE: Download annual report on deferred measures
The annual report submission is stored in the IRIS system indefinitely, and is accessible by the applicant (all IRIS Industry Managers associated to the submission, and for any IRIS Industry coordinator of the organization) at any time. In addition, it is always possible to print each page of the submission as a PDF file using the browser's functionality.
The automated generation of a specific application form for Annual reports on deferred measures, as a .docx file similarly to other paediatric applications, is being developed at this moment and should be available in the portal in the next few weeks. -
RE: Documents from the Applicant- Possibility to delete documents
Documents already uploaded can be deleted from a submission, but only while the submission is in "draft" status, i.e. it has not been sent to EMA yet. Additionally, the whole submission can be deleted when in "draft" status, including all uploaded documents, allowing an applicant to restart from scratch.
Once an application has been submitted to EMA, it is only possible to request a withdrawal, but not to delete the submission, or to remove any files uploaded, even if the submission is reopened for an update. This is by design and there are no plans to change this in the future. -
RE: Will PAM procedures transition to IRIS for lifecycle management?
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RE: IRIS notifications' recipients
Please see the reply to: IRIS portal communication by mail or on the portal? · IRIS (europa.eu) -
RE: IRIS portal communication by mail or on the portal?
Automated emails from the IRIS system are sent only to the "Portal contact" (a.k.a. "Submission contact") of the submission.
For emails sent manually, the EMA staff member will also normally include only the "Portal contact" as the addressee. If an email sent to the IRIS system contains other addressees, and the EMA staff person replying uses reply-to-all, then other addressees may also receive the reply; however it is to be noted that the IRIS interface used at EMA rejects email addresses that are not registered as users/contacts in the system.
By default, the Portal contact is the person who has created the submission in IRIS, however this role can be reassigned in the Industry portal by any Industry Manager associated to the submission (or by the Industry IRIS coordinator for all submissions), to any other Industry Manager associated to the same submission. This can be done any number of times. More details can be found in section 2.4 of the IRIS guide for applicants, available in the IRIS Portal.
Portal contacts are encouraged to change the portal contact as appropriate, for example before a period of absence or when leaving the company, and to set up auto-forward rules in their own email server, if desired.
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RE: Question regarding the meaning of the "Scoring foreseen ?" field
Tablet scoring refers to the breakage of a tablet to attain a desired efficacy dose. For more information, see for example Applied Sciences | Free Full-Text | Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps.
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