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PE009-13, the PIC/S guide to GMP for medicinal products
TGA interpretation and expectations for demonstrating compliance
Complaints and product recall (Chapter 8)
Clauses 8.7 and 8.8 of PE009-13 require that the procedures on complaints handling should include an assessment for counterfeit products. If counterfeiting is detected the TGA must be notified in accordance with the Uniform Recall Procedure for Therapeutic Goods.