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:
- You have an active EMA account.
- 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.
- 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:
- You have a valid EMA customer account number, which is a unique reference number for financial matters required to submit scientific advice applications.
- 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.
