Wrong MAH address in IRIS

Dear EMA,

We have noticed that when trying to enter the Marketing Status in IRIS that the MAH addresses for our products are incorrect despite the addresses being updated in the XEVMPD database several years ago.

Please can you explain how we can assign the products to the correct MAH address which is available in IRIS but our products are assigned to the old addresses.

Kind regards,

Pending the release of PMS (SPOR), IRIS data on Authorisation Medicinal Products are derived from SIAMED2. However, due to an incomplete synchronisation of IRIS with SIAMED2, some authorised product are associated with an old location (of the same or another organisation). EMA is aware of the problem and a process has been set up to reconcile the data prospectively and retrospectively.

For specific cases of urgency, please submit a Servicedesk request, indicating each product and the location ID of the correct marketing authorisation holder. Data will then be updated from the back end.