paolo chiarini

Hi, 

In my company there is a specific "cross-product team" in charge of work sharing (WS) applications. Currently I am acting as EU Agent for this cross-product team, even though I am not recorded as contact point in the EMA's database for any of the company's product.

According to what shared by EMA on 13 June 2024 during the “Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS”, after January 2025 for WS procedures Applicants will have to choose one of the product-specific contact points involved in the WS to act as "lead product". It seems that only one of the EU Agents of the products included in the WS can be the contact point allowed for communication to EMA. in other words, a role like mine above does not seem to be allowed since I am not a contact point for any product.

On the other hand, according to “IRIS guide for applicants” (EMA/444925/2018) the lead Authorisation product for WS is the product as indicated by the Applicant in the Letter of Intent. So, the person who is listed on the Letter of Intent, cover letter and application form as the point of contact with the agency will be the person who will be listed in IRIS as the point of contact when the case is opened and will be the person who will get the email from IRIS. Therefore, for WS procedures as long as I am listed on the letter of intent/cover letter/application form and have IRIS Industry Manager access for the relevant MAHs, I should be able to act as contact point.

QUESTION: Could you please clarify if I can act as contact point and can receive notification by IRIS for WS procedures considering the above scenario?

Many thanks in advance