Following the recent synchronisation of IRIS with Organisation Management Service (OMS), some organisation names may appear in IRIS with a prefix "[INACTIVE]" in front of the organisation name, (e.g., [INACTIVE]ABC Pharma).  

What does the prefix "[INACTIVE]" mean? It is an indication that organisation and/ or location record was made inactive in OMS, but not in IRIS as the organisation and/ or location might be linked to regulatory records, e.g., ongoing procedures, regulatory entitlements, products, manufacturing operations, or similar. This is a temporary solution to identify organisations and/ or locations in IRIS that will be inactivated once their connections to existing regulatory records in IRIS are resolved.  

Note: The presence of the prefix does not directly corelate to the validity of Wholesale distribution authorisation, Manufacturing importation authorisation, or similar, for that location.  

Steps to inactivate the organisation and locations in OMS: Organisations and locations in OMS can be inactivated following the request of the organisations or as part of data mastering. For more information on OMS please refer to these guidance documents. 

----> Required actions from IRIS applicants/ marketing authorisation holders

  • For completed procedures: If the company name OR organisation related to your submission appears in IRIS with the prefix "[INACTIVE]", please follow the respective procedural guidance and, if required, make a regulatory submission to move your regulatory entitlements to a new active location/address. 

  • For ongoing procedures: If the company name OR organisation related to your submission appears in IRIS with the prefix "[INACTIVE]", raise a ticket using dedicated Service Desk ticket category “IRIS – report an issue”. EMA will review each of these cases individually. 

  • For new procedure submission: Do not use organisations or locations with pre-fix "[INACTIVE]" unless you are applying to transfer the records to active locations or updating the name and/or address on the regulatory entitlements.