Mandatory Steps for Assessing Undesirable Effects (UE)
Collect as much information as possible concerning the case
What happened?
Which product?
How was the product used?
Did the user contact a medical professional?
Inform your Responsible Person (RP)
The RP will assess if the incident requires reporting
If yes, the RP will inform the Competent Authorities
Every product, sooner or later, will face an Undesirable Effect!
It is therefore crucial for any brand owner to know how to react.
Did you know?
It is a legal obligation to inform the Competent Authorities about any Serious Undesirable Effects!
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Facing a Vigilance case?
How to manage undesirable effects?
Cosmeto-Vigilance:
What's the difference between Undesirable Effects and Serious Undesirable Effects?
Undesirable Effect (UE)
"Adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product"
Serious Undesirable Effect (SUE)
"Causes temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies or an immediate vital risk or death"
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