Update of the procedure for managing quality defects and batch recalls for veterinary medicinal products
ANMV has updated its procedure for managing quality defects and batch recalls in veterinary medicines.
A quality defect observed on a veterinary medicinal product during marketing must be declared to ANMV and assessed by both the manufacturer concerned and ANMV. The procedure for managing quality defects and batch recalls describes, step by step, the steps involved in declaring and assessing a quality defect, right up to the management of a possible batch recall.
This procedure has just been updated to incorporate the provisions of European regulation 2019/6. It also presents an evolution of the quality defect rating grid for declared veterinary medicinal products. This rating makes it possible to assign a criticality level to the quality defect detected, and thus to guide the level of batch recall when it is deemed necessary.