Carlotte Lucas

The following updates have been made to the IRIS platform:

Hi Isha, the training will be posted on the IRIS website within a few days. In the meantime please reference the "IRIS guide to applicants (scientific applications)" also found in "Guidance & support" for any questions you may have. 

On 19 October 2020, the IRIS platform will go live with scientific advice. This means that as of that date EMA will require scientific advice applicants to use IRIS to manage scientific advice processes with EMA. The procedures concerned are:

• Human domain: Initial and Follow-up Scientific Advice, Initial and Follow-up Protocol Assistance, Initial and Follow-up Qualification Procedure
• Veterinary domain: Initial and Follow-up Scientific Advice

Registration steps

To begin using the platform from 19 October 2020, it is recommended that scientific advice applicants complete the registration steps ahead of time. You may find it helpful to refer to the quick interactive guide to IRIS registration process which provides a summary of registration actions in order to ensure that:

1. You have an active EMA account.
2. Your organisation is registered in EMA’s Organisation Management Service (OMS). It can take from five to ten working days to update or register a new organisation. You can also check if your organisation is already registered in OMS (and correctly mirrored in IRIS) directly in the IRIS system, at the IRIS locations list. 
3. You have the appropriate user access role and affiliation to an organisation. IRIS user roles are requested in the EMA Account Management portal.

To be able to submit your scientific application via IRIS you will also need to ensure that:

1. You have a valid EMA customer account number, which is a unique reference number for financial matters required to submit scientific advice applications.
2. You have a valid Research Product Identifier (RPI) that EMA uses to track medicines through pre-authorisation procedures. Requests for new RPIs, including requests for transfers of RPIs, are submitted via IRIS. In cases, where a request for RPI also requires registration of an active substance in the EMA’s public list of substances this may take up to five working days.

IRIS registration steps are explained in detail in the IRIS guide to registration.

Upcoming trainings

· IRIS registration and request of RPI - 24 September

· How to submit an Initial and Follow-up Scientific Advice (human) application in IRIS - 13 October

· How to submit an Initial Scientific Advice and Follow-up (veterinary) application in IRIS - 14 October

More information on how to attend the live sessions is available by clicking on the training links and visiting the events page on the EMA corporate website. Links to the broadcast will be published closer to the training dates. Please note you do not have to register for the trainings.

The training sessions will not be interactive but participants can submit questions in writing afterwards, which EMA will address in its written guidance materials that will be shared after the trainings. EMA will also publish the training video recordings.

The following updates have been made to the IRIS platform:

• 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.