Cosmetovigilance

Cosmetovigilance is defined by the collection, evaluation and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. Together with other tools, cosmetovigilance contributes to post market surveillance.

This task falls to the Responsible Person (RP) to continuously monitor and record such effects and regularly re-assess the risk associated with them.

From July 2013 the current European Cosmetics Directive was replaced by the Regulation (EC) No. 1223/2009. This new regulation places an obligation on distributors to notify serious undesirable effects occurring in Europe to the local competent authority.

We can help the Responsible Person (RP) to meet their regulatory, compliance and safety obligations for cosmetic products.

For more information please contact us at enquiries@pharmafile.ie