What is Cosmetic Adverse Effect Reporting?

Cosmetovigilance can be defined as “The collection, assessment, and ongoing monitoring of spontaneous reports detailing adverse events observed during or after the typical or reasonably anticipated use of a cosmetic product.”

Cosmetic Adverse Effect Reporting (AERs) is therefore the same in principle as other Pharmacovigilance disciplines, in that the details of each reported case are required to be recorded, reviewed, and forwarded to an official agency who will hold that information and potentially take further actions.

Cosmetic AER Management differs however in two fundamental ways:

The obligation to manage and report Serious Undesirable Effects (SUEs) lies squarely with the manufacturer’s designated Responsible Person.
Cases are reported to the National Competent Authority (NCA) where the effect occurred.

Click for more information about our cosmetic Responsible Person services.

Click for more information on the Cosmetics Product Regulation.

Cosmetic product UEs, SUEs & Misuse.

Reporting Cosmetic AERs.

Adverse effects fall into three categories:

UE (Undesirable Effect):
An adverse reaction to human health linked to the normal or reasonably anticipated use of a cosmetic product.

SUE (Serious Undesirable Effect):
An adverse reaction resulting in temporary or permanent functional impairment, disability, hospitalization, congenital anomalies, immediate life-threatening risk, or death.

Misuse:
The intentional and inappropriate use of a cosmetic product in a manner inconsistent with its normal or reasonably anticipated use or its specified warnings and precautions.

Who Should Report Cosmetic Adverse Effects?

The Responsible Person is obligated to report all serious adverse effects that are known to them or reasonably expected to be known.

Healthcare Professionals (HCPs) must report all serious adverse effects attributed to the normal or reasonably anticipated use of a cosmetic product. They may also report other adverse effects, including those resulting from product misuse.

Beauty Professionals and Consumers are encouraged to report all adverse or serious adverse effects, including those stemming from product misuse.

Click for information on Pharmacovigilance.

Why choose Aegisana for all your Cosmetic Adverse Effect Reporting needs?

We understand AERs.

Our deep experience and expertise in handling all types of case reporting across all forms of pharmacovigilance ensures the management of your cosmetic product cases will be efficient and fully compliant

A choice of options.

We can act as the Responsible Person for your products, or alongside your Responsible Person, and are able to work with our systems or your systems to handle all your cosmetic case processing needs.