What is Cosmetovigilance?
Responsibilities of the Responsible Person 3 - Cosmetovigilance
What is Cosmetovigilance?
Cosmetovigilance refers to the collection, evaluation, and monitoring of spontaneous reports of unwanted effects observed during the normal or foreseeable use of cosmetic products.
Cosmetovigilance is vital for responsible individuals to ensure the safe use of cosmetic products by systematically monitoring unwanted effects and taking necessary measures to minimize the harm that cosmetic products may cause.
What is an Unwanted Effect/Serious Unwanted Effect?
Following the normal or foreseeable use of a cosmetic product, an Unwanted Effect (UE) refers to an unexpected effect that adversely affects human health, while a Serious Unwanted Effect (SUE) refers to an unwanted effect resulting in temporary or permanent functional impairment, disability, hospitalization, congenital anomalies, or sudden life-threatening risks or death.
How to Report Cosmetic Unwanted Effects?
Unwanted effect reports can be submitted through the PTS (Product Tracking System - UTS in Turkish) and the PTS Mobile application. End-users, healthcare professionals, and responsible persons can fill out and submit the "Unwanted effect/serious unwanted effect reporting form" when reporting unwanted effects related to cosmetic product use.
What are the Responsibilities of the Responsible Person?
- Establishing, operating, preparing, reporting, updating, and implementing all necessary working methods for monitoring and evaluating all suspected unwanted effects/serious unwanted effects received by the system for the conduct of cosmetovigilance activities,
- Collecting, recording, archiving, evaluating, and maintaining up-to-date information on the risks and safety of cosmetic products, including ensuring that up-to-date information is included in the product information files of cosmetic products within this scope,
- Providing the product information file, including safety studies, for the relevant cosmetic product, including sales information if requested by the institution, for the evaluation of the risks associated with the cosmetic product, immediately and in full,
- Conducting a causality assessment between SUE and the cosmetic product, reporting to the Institution within 15 working days without delay along with the measures taken, and providing other necessary information and documents requested by the Institution on time,
- Ensuring necessary cooperation and coordination with the Institution,
- Ensuring that information about the content of cosmetic products and SUEs is readily accessible to the public.