Post-Market Surveillance
It is the responsibility of each brand owner to continue to collect information related to the use of their products after they have been made available to consumers as well as to ensure that they continue to comply with the applicable legislation considering the ongoing regulatory updates.
Manufacturers must keep their EU Responsible Person informed of any changes in formulation, claims, product names or any other matters that could potentially impact the compliance of their product.
As consumers use the products, any undesirable or serious undesirable effects (SUE) reported by end-users should also be recorded within the respective Product Information File (PIF), revised within the Safety Assessment report if needed and, depending on the circumstances, reported to the Competent Authorities.
When a manufacturer becomes aware of a non-compliant product entering the market, non-compliant batches, etc. They along with the Responsible Person must take action immediately to resolve the situation.
Learn More:
- Scope & Classification
- The Regulation: EC 1223/2009
- EU Responsible Person
- Product Information File
- Good Manufacturing Practices
- Cosmetic Product Safety Report (CPSR) - Part A & B
- Mandatory Safety Testing
- EU Labeling
- Pre-Market Notification: Cosmetic Product Notification Portal (CPNP)
- Nanomaterials
- Risks of Non-Compliance
Questions about the post market surveillance? Contact us now to learn more!
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