Posted Fri, 09 May 2025 08:50:00 GMT by Michela Cesco Gaspere
We are about to submit a request for Removal of OD from EU Register.
When I created the draft submission, I noticed that the system has automatically updated the name of the active substance to a name that is not correct.
The name of AS still appears correct in the list of my Organization Reg Entitlements.
How should we proceed ?
Many thanks.
Posted Mon, 12 May 2025 18:39:16 GMT by Paolo Tomasi EMA
The name of the substance changes automatically if the preferred term changes in SMS. To provide an update to substance name(s) in SMS, please follow the procedure described in the IRIS guide to registration and RPIs v2.16

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