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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. -
Paediatric submissions in IRIS: no need for Letter of Authorization or the Part A PDF form
IRIS Industry Users should note that uploading a Letter of Authorization is not required in IRIS for Paediatric submissions (or for Scientific Advice, PRIME, Orphan, or ITF submissions), since the portal already performs authentication of the user at login. In addition, there is no need to create and upload also the old Part A PDF form, since the information required is already included in the webforms of the IRIS Industry Portal, or to upload previous EMA paediatric decisions for the same product.
EMA aims at improving and simplifying submissions for scientific procedures via the IRIS portal. -
Paediatric submissions in IRIS: one condition per submission
In IRIS each submission for a Paediatric Investigation Plan or a Product-specific Waiver must specify a single condition. For example, if a PIPs is required for two separate conditions (not indications in the same condition), then two separate submissions are required, one for each condition, and separate Regulatory Entitlements will be generated by IRIS after a positive decision.
This is due to legal and technical reasons, among which the following are of particular relevance:
- Regulatory entitlements for development-related procedures in IRIS are linked to a single condition, as for Scientific Advice and Orphan Designations.
- Art. 14 of the Paediatric Regulation requires EMA to publish a list of the waivers granted, which is not possible if a Regulatory entitlement contains several conditions, for some of which a PIP may be granted and for others a Product-specific waiver is granted. Regulatory entitlements for paediatric applications are thus of two categories, Paediatric Investigation Plan (with or without deferrals or partial waivers) and Product-specific waiver.
- Experience with the past system and database has shown that it is more convenient for applicants to have separate PIP decisions for different conditions, to prevent the "never-ending PIP" issue and to be able to claim the reward after completion of development in a single condition (i.e. after completing the "reward PIP"). For additional information on this, please see EMA policy on changes in scope of PIP decisions (europa.eu).
Each submission should contain all the relevant information and documents. It is of course possible to re-upload the same document(s) several times, and copy paste the same data sections for more than one application, whenever the applicant believes this to be appropriate. In IRIS, it is possible to open multiple instances of the IRIS portal in different browser tabs, at the same time, and create separate submissions in parallel.
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