COSMETOVIGILANCE FOR YOUR BRAND
As soon as a brand development project takes shape, the question quickly arises: who is responsible for bringing the product to market?
European manufacturer, non-European manufacturer wishing to sell in Europe or the UK, importer of a non-European brand, manufacturer of a brand wishing to sell in the US and registered with the FDA...
Globally, the position of responsibility meets specific and distinct requirements in terms of legal structure, associated degrees and competencies, and behavior towards the competent authority or the consumer. The Responsible Person ensures that all obligations related to product compliance have been met. Primarily, they ensure the legal responsibility for the product's safety by guaranteeing it poses no risk to human health.
The safety relationship established between the brand and its consumer is cosmetovigilance. It involves handling any public health incident reports, compiling adverse events related to the product, and communicating with competent authorities so they can take precautionary measures.
COSMETOVIGILANCE is the cornerstone of any consumer safety system for cosmetic products.
All countries in the world require a cosmetic brand to be safe for its consumers. In Europe and the UK, the brand is legally represented by a Responsible Person in their territory. The risk can therefore be assumed by the brand’s leader, but this responsibility can be delegated to CLEAR. In daily practice, CLEAR is obligated to ensure compliance with regulatory requirements (such requirements include: safety, GMP, PIF, notification, composition and ingredients, cosmetic product information file, labeling, claims, and communication of serious adverse effects...). We ensure cosmetovigilance for your brand.
To take any immediate corrective action, withdrawal/recall if appropriate in case of non-compliance. To immediately inform the competent authorities and other economic operators in case of a risk to human health. To provide the competent authorities with the information and documents to demonstrate compliance with cosmetic regulations upon their request. To keep the Product Information File easily accessible to the competent authorities for a period of 10 years after the last batch is placed on the market.
