We have undertaken MAH transfer activities for several products, including the RPI within IRIS, but the products are not currently visible within the marketing status reports. Is there another action needed in order to be able to report marketing status updates for these products?
Suggestion
Please note that RPIs have no relationship with marketing status submissions. All “Authorisation Products” have a parent RPI, and multiple authorisation products may share the same RPI, for example in the case of duplicates, informed consent, orphan and non-orphan products containing the same active substance(s).
Marketing status submissions must be done for an “Authorisation Product” which has a valid Marketing Authorisation, not for an RPI.
Regarding transfers:
- an RPI can be transferred to another location of the same organisation, or to a different organisation, directly by the current RPI owner via an IRIS submission. The process is completely automated and is almost immediate.
- On the other hand, a transfer of MAH for an authorised product is a different procedure, requires a decision from the EC, and is not currently managed in IRIS. Once a transfer of MAH for an authorised product is completed, the new MAH is (manually) updated in IRIS as well. This may require a few days. If you suspect that this update has not been done in IRIS, please raise a ServiceNow incident.