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Update active substance name & RPI
Update active substance name & RPI
Posted
Wed, 15 Jan 2025 12:26:42 GMT
by
Marion Bailly
How to change the name (active substance name) associated to my RPI?
The name given to the active substance and so linked to the RPI is not accurate and needs to be updated for accuracy purpose.
Answer
Posted
Thu, 16 Jan 2025 14:59:08 GMT
by
Paolo Tomasi
EMA
An RPI name is the concatenation of the preferred terms for each substance contained in the RPI, in alphabetical order. To change the name of an RPI it is necessary to update the name of the concerned substance(s) in SMS. You can update the name by providing the necessary information, including the substance ID, in this form:
Request SMS services
.
Once the substance name is updated in SMS, the RPI name will change automatically. If there is any ongoing case associated to the RPI, before the Opinion, the name of the product in the case will also change automatically, and this will be reflected in the Regulatory entitlement created or modified (if any).
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