Mandatory Steps for Assessing Undesirable Effects (UE)

Mandatory Steps for Assessing Undesirable Effects (UE)

Collect as much information as possible concerning the case

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?

What happened?

Which product?

How was the product used?

Did the user contact a medical professional?

Inform your Responsible Person (RP)

Inform your Responsible Person (RP)

The RP will assess if the incident requires reporting

The RP will assess if the incident requires reporting

If yes, the RP will inform the Competent Authorities

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.

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!

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?

Facing a Vigilance case?

How to manage undesirable effects?

How to manage undesirable effects?

Cosmeto-Vigilance:

Cosmeto-Vigilance:

What's the difference between Undesirable Effects and Serious Undesirable Effects?

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"

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"

Serious Undesirable Effect (SUE) 

"Causes temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies or an immediate vital risk or death"

All Right Reserved 2021 © Obelis Group

All Right Reserved 2021 © Obelis Group

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We are introducing the new Vigilance Card program, providing you with everything you need in order to manage undesirable effects.

We are introducing the new Vigilance Card program, providing you with everything you need in order to manage undesirable effects.