The following updates have been made to the IRIS platform:
1. Transferring an RPI from an existing RPI sponsor to a new RPI sponsor can now be done in IRIS:
Users with the role "Industry Manager" can transfer the RPI by completing the following steps:
- From the IRIS home page, click on “Draft submissions” and then click “New draft”;
- Select the "Sponsor Type" (Organisation or Individual);
- If applying on behalf on an organisation, a list will appear in the "Organisation" field when clicking on the magnifier, showing only the organisation(s) to which you are affiliated. Once an organisation is selected, select the relevant location;
- Under "Submission Type" select "Transfer a Research Product" and confirm; under "Manager" select at least one manager for the application;
- Click on "Create and Next": you can now add contributors to your submission (optional). Click on "Continue to Submission form";
- Click on "Select Research product to be transferred", then select the proper RPI using the search icon option and click on “Save and Return”;
- Click on "Transfer Details", then select the "New Sponsor Type" (Organisation or Individual) and the "New Organisation" including correct address. Once all details have been added, click on “Save and Return”;
- Click on "Declaration", than select the checkbox for the declaration and click on “Save and Return”;
- Once the step above have been completed, click on “Submit Application”. The RPI will be transferred automatically and an email will be sent to the old sponsor and the new sponsor regarding the changes made.
This process replaces the previous RPI transfer process of having to raise a request to the EMA Service Desk.
2. The "My Draft Submissions", "Ongoing Submissions", and "Completed Submissions" tabs have been merged into one "Submissions" tab on the Industry Portal
When clicking on the "Submissions" tab, the user still has the option to click on the "My Draft Submissions", "Ongoing Submissions", and "Completed Submissions" sub tabs. There has been no change in functionality to any of the three sub tabs.
3. A "Regulatory Entitlement" tab has been added to the Industry Portal
The new tab enables users to see a list of all regulatory entitlements related to the organisation(s) the user is affiliated to. It is possible to filter the regulatory entitlements by entitlement number, entitlement type, sponsor, product name, EU number, and date of decision.
