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.


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