COSMETOVIGILANCE

COSMETOVIGILANCE: ISSUES AND STEPS

Cosmetic products are commonly used and are designed to be safe. Adverse reactions resulting from a normal or reasonably foreseeable condition are scarce, and completely reversible. But some undesirable effects may occur. It is important to monitor the cosmetic market to maintain a high level of safety.
Thus, the main missions of Cosmetovigilance are to gather this information, make the causal assessment and finally make the assessment of the the ingredients involved.

Cosmetics are used at a large scale by consumers, they are everyday products, and their safety must be ensured. However, users may report undesirable reactions due to the use of these products, ranging from irritation, itching to serious undesirables effects.

These adverse effects must be taken into account and have a place in the safety assessment. Post-marketing information are an additional and essential source of information to ensure the maintenance of a quality and safe product for users.
A Responsible Person has the obligation to have a cosmetovigilance procedure within the company to collect, record, evaluate and implement corrective actions.

What is a cosmetovigilance procedure?
What are the implications of cosmetovigilance?
What are the steps in reporting an undesirable reactions within the company?
 

AGENDA

• Introduction to cosmetovigilance: definitions
• Regulatory issues and context
• Stages of the cosmetovigilance procedure
• Case study 

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