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Submission receipt notification sent in error by IRIS for old, closed Paediatric procedures
During the migration of old, closed paediatric procedures from EMA's previous system into IRIS, the standard submission receipt notification has been erroneously sent to the case contact person by an automated workflow. This has affected more than 5000 cases.
Please ignore any submission receipt email for Paediatric cases with a case title starting with "EMEA-", as these are the migrated cases. There is no need to reply to the email or to undertake any action.
We apologise for any confusion induced, and we thank you for your understanding. -
RE: PIP Modification
IRIS contains procedural data, but not the complete outcome (adopted key elements) of the previous procedures or those managed in IRIS. A request for modification should specify the new proposed key elements. For issues c and d, please create a ServiceDesk ticket in Report an issue with IRIS, including detailed information and screenshots of the problems encountered. -
RE: Generation of report from PIP deferral
The generated application form is indeed downloadable, but for Paediatric procedures not all structured fields are currently included in the document, as tables would become unreadable if too many columns are added to them. As the submission and its data in structured fields are always accessible in the portal, a possible alternative for Industry would be to use a web scraping (screen scraping) application to download the information.
Regarding the second issue reported, if a submission contact (portal contact) leaves an organization, for draft or ongoing submissions a user with the role of "IRIS Industry coordinator" can add new users to the submission with the role of IRIS Industry manager, so that they can visualize all data.
To address your suggestions, two user stories have been added to the IRIS development backlog:- 193553 - Extend addition of submission managers also to closed (completed) submissions, in the Industry Portal
- 193557 - Improve the "Application form" document for Initial PIPs, Modification, PSW and Compliance check (all structured data to be included in the document)
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RE: Limited information available for sPIP submission
Information on the planned date of submission of the MAA will be recorded in the RPI, so that it can be kept up to date for all submissions based on RPIs or Regulatory entitlements. EMA intends to track submission pipeline information for pre-submission products in early development via the RPI record. The information is about the forecasted date of submission of the next Marketing Authorization Application, eligibility basis and legal basis of the application.
The functionalities are currently in development, and are expected to be available later in the year. Industry owners of RPIs will be able to update the information at any time in the RPI, using the Industry portal; in addition, at every new submission based on an existing RPI or regulatory entitlement (e.g., Paediatric, Orphan, Scientific Advice and PRIME submissions) applicants will be offered the possibility to update this information in the RPI, or confirm its validity.
The information provided in the RPI is not binding and can be changed at any time by the RPI owner. The same functionality will also be available to update the Product Contact for the RPI. -
RE: Key Elements description
No field in the key elements is supposed to be limited to 88 characters. Please raise an incident in Report an issue with IRIS. -
RE: PIP submission in EMA IRIS Portal, includes questions on submission pipeline ?
EMA intends to track submission pipeline information for pre-submission products in early development via the RPI record. The information is about the forecasted date of submission of the next Marketing Authorization Application, eligibility basis and legal basis of the application.
The functionalities are currently in development, and are expected to be available later in the year. Industry owners of RPIs will be able to update the information at any time in the RPI, using the Industry portal; in addition, at every new submission based on an existing RPI or regulatory entitlement (e.g., Paediatric, Orphan, Scientific Advice and PRIME submissions) applicants will be offered the possibility to update this information in the RPI, or confirm its validity.
The information provided in the RPI is not binding and can be changed at any time by the RPI owner. The same functionality will also be available to update the Product Contact for the RPI. -
RE: Combination product with separate RPIs
There are three possibilities:
1) fixed dose combination: must be a single RPI
2) combination pack (two or more separate formulations in different immediate containers, but co-packaged in the same presentation): must be a single RPI
3) co-administration treatment: (two separate products, in different formulations and separate presentations, but administered together in the same clinical trial): these must be separate RPIs. For Orphan designations and Paediatric Investigation plans, only one RPI should be provided per application, and separate submissions should be done for the two products (if desired). For Scientific Advice, it is necessary to specify the main RPI, but it is possible to mention separate RPIs for co-administration product(s) in the submission; these RPIs must also be "owned" by the applicant. -
RE: PIP Initial Submission and use of IRIS from 04 June 2024
For specific issues with a Regulatory entitlement, please Report an issue with IRIS which will create an incident ticket in ServiceNow. Please provide as much information as possible, including screenshots of the portal, any error messages shown, the list of contact persons displayed, and the email of the user attempting to update the information. -
RE: PIP Initial Submission and use of IRIS from 04 June 2024
There is no plan to hold a webinar specifically for paediatric submissions in the IRIS Industry portal. However, please note that the Paediatric submissions in IRIS were shown in the EMA Quarterly System Demo Q1 - 2024, and that the processes shares most of the steps with the other procedures already managed in IRIS, for example Orphan designations, Scientific Advice or PRIME designation. Video recordings of previous webinars for these procedures are available in the Guidance and Support Section of the IRIS homepage.
Regarding the IRIS Guide to Applicants (creation of submissions), this is in progress and the updated guidance will be available by the go-live date. -
Paediatric Regulatory entitlements in IRIS (Decisions on PIPs and product-specific waivers)
Communication to Industry on data reconciliation for Paediatric Decisions in IRIS
As part of the transition of Paediatric procedures to IRIS, EMA has assigned a specific Industry organisation and location to each Paediatric Regulatory Entitlement in IRIS. These correspond to the EMA Decisions granting a PIP (Paediatric Investigation Plan) or a product-specific waiver, or a modification of an existing PIP.
The latest decision on a PIP, that is either the initial one if no modification has been requested or the latest modification of the PIP, and all decisions on product-specific waivers are already visible for the holders, in the IRIS portal section named “Org. Reg. Entitl.”. IRIS Industry users will be able to check which Paediatric regulatory entitlements are assigned to the organisation(s) to which they are affiliated.
In addition, the Excel file attached contains the list of all latest decisions on paediatric regulatory entitlements, with the assigned organisation / location.
Please note that the reconciliation and assignment has not always been possible to the address mentioned in the original EMA decision, for reasons including for example:
- The address may not correspond to an existing, active location in OMS (Organisation Management Service, the master data used in IRIS).
- The organization of the holder does not exist anymore in that country, due to closure or merger.
- The name of the organization in the original application and decision may not correspond sufficiently to that stored in OMS and IRIS.
- The application and decision were in the name of an individual, who does not have an IRIS contact or has moved to a different organization.
Holders of PIP/waiver decisions are invited to check the attached list, including decisions still assigned to EMA; should they wish to transfer a Paediatric Regulatory Entitlement (PIP/waiver decision) to another location of the same or a different organisation, the procedure can be done directly in IRIS, using the the process type “transfer of PIP or waiver”. This process type allows a current holder of a Paediatric Regulatory Entitlement to directly transfer an entitlement to a different location of a same or another organization, via a self-service process in IRIS. Note that Regulatory entitlements, including PIPs and product-specific waivers, should be assigned to the location corresponding to the legal seat of an organisation.
In case of problems, please raise an incident in the EMA ServiceNow platform (use “Reassignment of Paediatric Regulatory entitlement(s) in IRIS” as the subject of the request, to facilitate routing).
Finally, please note that for each Regulatory entitlement the contact person from the applicant and the email for interested parties have been added to the records. It is possible for holder to edit these data directly in the IRIS portal, and to add a telephone number for interested parties, simply by clicking on each blue Entitlement Number (decision number) in the tab “Org. Reg. Entitl.”.
EMA plans to publish Paediatric Regulatory Entitlements, including the email and telephone number for interested parties (but not the contact person), in a future Register in the IRIS portal, like the existing one on orphan designations.
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