Post-Market Surveillance

Ensuring Compliance

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.