IRIS contact point for worksharing variations

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

Dear Paolo,

The “IRIS guide for applicants” (EMA/444925/2018)  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-applicants_en.pdf states:

"For PLM procedures “submission contact” is the “Person/Company authorised for Communication between MAH and Authorities after Authorisation” of the lead Authorisation Product within the current submission, held by EMA. For worksharing or grouped variations affecting more than  one product, the lead Authorisation product is the product as indicated by the Applicant in the Letter of  Intent."

This means that the contact (recorded at EMA) of the lead product will become the contact of the case (submission contact) in the IRIS portal.

The "submission contact" role can be reassigned at any moment for draft and ongoing submissions, and repeatedly, by any of the Industry/Parallel distribution managers associated to that submission, but the EMA will send communications only to the “single” "submission contact", assigned in that moment, by default. This is for efficiency and security reasons."

Once the submission is created on the IRIS  portal (case is recorded by EMA), the default contact (contact for the lead product) will receive an email. If you are not the contact of the lead product, then the default contact can set your user as a contact (if you have IRIS Industry manager role)  once the case (submission) is created.  They can log on the IRIS portal and set you ( for example) as contact for that case and you will be able to receive all communication to your email, as usual. Please go ahead and request and IRIS Industry Manager role for the organisation LOC ID which is the marketing authorisation holder (MAH) for the products part of the worksharing.

Best regards,
IRIS team