Responsible Person Service.
Represention & compliance for your cosmetic products.

What is a Responsible Person in cosmetovigilance?

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 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 and Veterinary Pharmacovigilance.

Why choose Aegisana's Responsible Person service?

Our depth of knowledge.

Our deep experience and expertise in handling all types of case reporting across all forms of pharmacovigilance makes us a great choice to designate for your Responsible Person service and ensures the management of your cosmetic product cases will be efficient and fully compliant.

We can also work alongside your existing or own Responsible Person and are able to work with our systems or yours to handle all your case processing needs.

Consistently good support.

Your confidence in our Cosmetovigilance services and solutions comes through excellent communications, and the consistent delivery of high-level support and outputs throughout your journey with us.

No matter how complex your requirements are, we can provide efficient and effective solutions to meet them.