Cosmetovigilance services.
Protecting people and products.

What is Cosmetovigilance?

Cosmetovigilance encompasses the post-market surveillance of cosmetic products to identify and address health-related adverse effects resulting from their use.

It 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.”

The prevailing regulations governing all cosmetic products marketed in Europe derive from the Cosmetics Product Regulation (EC) No 1223/2009, which was introduced in 2013 to establish an efficient pharmacovigilance system.

This system facilitates the detection of adverse effects that were not initially identified during safety assessments conducted prior to the product’s market launch.

Cosmetovigilance Documentation.

Fundamentally, the key distinction between cosmetovigilance and pharmacovigilance centers on the designation of the ‘Responsible Person‘, who may be the manufacturer, importer, or a third-party service, such as Aegisana, authorized to oversee and report on the safety and effectiveness of their products, and their responsibilities under the legislation.

Cosmetovigilance, therefore, hinges on the following factors:

  • The execution of safety studies including the Cosmetic Product Safety Report (CSPR), the generation of other neccessary reports, and the implementation of any necessary corrective actions.
  • The reporting of adverse effects and associated information.
  • The documentation, investigation, validation, and assessment of adverse effect reports to prevent future occurrences.


What is a CSPR?

Before introducing a cosmetic product to the market, the appointed Responsible Person must ensure that it has undergone a cosmetic safety assessment, known as the Cosmetic Product Safety Report (CPSR). This assessment involves a comprehensive scientific evaluation of the cosmetic product’s safety, performed by a qualified individual (Safety Assessor). The Safety Assessor collaborates with the appointed Responsible Person to evaluate, document, and maintain the report.

The CPSR is an integral part of the Product Information File (PIF), a two-part regulatory dossier that contains information related to safety, manufacturing, packaging, labelling etc.

Click for information on Pharmacovigilance.

Why use Aeigisana’s Cosmetovigilance services?

Keeping you compliant.

Our pharmacovigilance team has the experience and understanding of all aspects of pharmacovigilance within the Cosmetic Products Regulation, and what is required to ensure your products are fully compliant.

We can efficiently handle all of your UE, SUE and Misuse cases within our system or in collaboration with yours. We can also assume the role of the Responsible Person for your products, ensuring that they adhere to all regulatory standards.

Our commitment is to establish a resilient and strategic partnership with you, covering your entire range of cosmetic products. Our goal is to ensure that your products stay safe, compliant and marketed.