IRIS role for contact person scientific service and product defects/recall

Considering the new EMA requirement to have an active EMA account and relevant IRIS role for contact person scientific service and product defects/recall, in order to choose the most appropriate IRIS role could you please clarify which are the activities that the above people will be called to do/receive on IRIS portal? Could you please inform if the list of contact person for each CAP is listed on the platform or somewhere else?

Thank you so much
Kind regards
Elena

Dear Elena,

Please refer to the IRIS guide for applicants and the IRIS guide for registration. Regarding the list of persons registered for your organisation, we are not able to share this for GDPR reasons, however your organisation’s IRIS – eAF Industry User Admin should have the overview for their organisation’s registration.

Best regards,
Caterina

Dear Caterina, 

Like Elena we are struggling to understand what access in IRIS we should provide to the MAH contacts for receipt of EC decision, scientific services and product defect and recalls. 

the Iris guides you are referencing do not explain in detail why these contacts need to have access to IRIS or how the EMA intends to communicate with them e.g. do you now intend to send the EC decision via the IRIS portal??

Should these people be given an IRIS manager role for example, even though they will not be creating or editing any submissions etc. 

thanks
Nicola