Linda Garner Manager

 I have a few questions regarding the assignment and role of the Lead Marketing Authorization Holder (MAH) in the PSUSA procedure as per the EMA guidelines:

1. Where should the assignment of the Lead MAH be captured? Is it required to be included in the XML delivery file?
2. How and where will the Lead MAH be displayed within the IRIS system?
3. Is there any change to the payment of fees due to the assignment of a Lead MAH? Specifically, will the fees still be divided among all the MAHs concerned proportionately to the number of chargeable units?

I would appreciate your clarification of the above points.

I would like to seek clarification on the access requirements for the Qualified Person for Pharmacovigilance (QPPV) within the IRIS system. Specifically, I have the following questions:

1. For which Marketing Authorization Holders (MAHs) does the QPPV need to have access within the IRIS system?  Does he need access for all MAHs held by the organisation, including those for EU national products
2. If an individual with the organisations has IRIS Industry Coordinator access for the same MAHs as the QPPV, can they, upon receiving a IRIS notification email from the QPPV, go into the IRIS system and assign a different portal contact to the case so that future communications for that case go to the new portal contact rather than the QPPV?  For example, if a safety referral had been initiated by EMA.

Your guidance in providing clarification in this area would be appreciated so we can ensure that our QPPV is ready to receive any future notifications.

I agree this is good news. Can you confirm whether we can have more than one person having the IRIS Industry Coordinator role for each organisation.