CEPRA offers a consultancy service for the management of surveillance of cosmetic products already placed on the market (COSMETOVIGILANCE).
Regulation 1223/2009 requires the Responsible Person to promptly notify the competent authorities of any case of serious undesirable effect (SUE) resulting from the use of a cosmetic product.
CEPRA provides companies with full assistance in the management of cosmetovigilance by providing the following services:
- Establishment and management of a post-marketing surveillance system: We support companies in establishing and maintaining an internal continuous monitoring system for the detection and management of undesirable effects.
- Collection, evaluation and monitoring of adverse effect reports: We manage the collection of reports of undesirable effects observed during or after product use, providing all the information needed to open a file and launch a thorough investigation.
- Causality assessment: We analyse the possible correlation between the reported effects and the use of the suspected cosmetic product.
- Notification to competent authorities: In case of an SUE, we take care of the official notification to the competent authorities, filling out the appropriate forms and ensuring that all information is complete and timely.
- Updating the Cosmetic Product Safety Report (CPSR): We support the continuous updating of the CPSR, taking into account data on serious undesirable effects and cosmetic product safety.
- Archiving and organisation of documentation: We take care of the systematic archiving and management of all documentation relating to undesirable effects (UE).