The procedures on complaints handling require an assessment for counterfeit products (clauses 8.7 and 8.8 of PE009-13). If counterfeiting is detected the TGA must be notified in accordance with the Uniform Recall Procedure for Therapeutic Goods.
A recall procedure should be in place as per the requirements of uniform recall procedure for therapeutic goods.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.