Adverse Event Reporting and Cosmetovigilance

Receipt, assessment and reporting of undesirable and serious undesirable effects under Article 23, with direct interface to the competent authority on the brand's behalf.

Assessment of reported undesirable and serious undesirable effects (SUE)

Notification of serious undesirable effects to the competent authority under Article 23 and the EU SUE Reporting Guidelines

Maintenance of the cosmetovigilance record within the Product Information File

Direct correspondence with the authority, for example the HPRA in Ireland, on the brand's behalf

Cosmetovigilance is the continuing duty to monitor, assess and report the undesirable effects a cosmetic causes in use. It does not end at launch, and it rests on the Responsible Person.

Regulation (EC) No 1223/2009 distinguishes an undesirable effect (Article 2(1)(o)) from a serious undesirable effect (Article 2(1)(p)), the latter resulting in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomaly, immediate vital risk, or death. Under Article 23, the Responsible Person must, without delay, notify the competent authority of all serious undesirable effects known or reasonably expected to be known to it, the corrective measures taken, and the information identifying the product. Distributors must pass such reports to the Responsible Person, and the authority shares them with the authorities of other Member States. The notification follows the European Commission’s SUE Reporting Guidelines, and the cosmetovigilance record is maintained within the Product Information File under Article 11.

We receive and assess reports, make the Article 23 notifications within the required timeframes, and correspond with the authority, for example the HPRA in Ireland, on the brand’s behalf. Where an effect points to a wider problem it feeds into recall and reformulation decisions. This work forms part of our Responsible Person service.