This situation usually occurs when the Initial Scientific advice of reference (Regulatory Entitlement) was given to a different Organization (legal entity in a country, for example Initial advice given to ACME France, but now ACME Germany is requesting the follow up), or even to a different Location of the same organization (e.g. initial advice given to ACME France, Paris, but follow up being requested on behalf of ACME France, Lyon). This is a general rule of IRIS: currently only Regulatory Entitlements and RPIs assigned to the same Location are visible when creating a submission on behalf of a specific location.
There are two workarounds for Scientific Advice:
- If the initial Scientific Advice was granted to another Organization: the initial Organization can transfer the Scientific Advice Regulatory Entitlement to the new Organization. This is done in IRIS with a specific, automated process.
- If the initial Scientific Advice was granted to another Location of the same Organization: create the submission on behalf of the same Location of the Initial Scientific Advice. (workaround 1 could also be applied here).
Of note, we are working to remove the issues caused by the second situation, by making visible all Regulatory Entitlements (Orphan designations, Initial Scientific Advice letters, etc.) and RPIs associated to a given Organization, regardless of the Location, but this is not yet in production.
If the workarounds above do not solve your issue, please send a ServiceDesk ticket with the specific details of the Scientific Advice procedure in question.