Batch recall shall be proposed by the operator of the veterinary medicinal product or the person responsible for placing the product on the market following the risk assessment of the identified quality defect before being validated and notified by the Agency.
It may also be requested directly by the Agency where a health risk to animals, humans or the environment is identified.
Batch withdrawal may be carried out at various marketing stages depending on the extent of the risk involved: At the level of the manufacturer’s and depositary’s stock, wholesale distributors or veterinarians and other entitled persons, or even the owner of the animals in the event of a critical risk.
The operator of the medicinal product is responsible for the proper completion of the batch recall which he implements in accordance with the procedures laid down by the Agency (nature of the messages to be distributed, the scope of the recall, etc.).
If you have any questions about a lot reminder, you can contact the Agency at the following address: DQ_ANMV@anses.fr
Public Health Code (Articles R.5141-45, R.5141-70, R. 5141-136, R.5142-52).
Good distribution practices (Chapter 6): Procedure for the organisation of a reminder, assessment of its effectiveness, rapid execution at any time.