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anses

French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 08/04/2020

Batch recall of a veterinary medicinal product

A batch recall is considered following identification of a quality defect or pharmacovigilance problem, or following a decision to suspend/revoke a marketing authorisation or temporary authorisation for use.

A batch recall is requested by the Agency when a health risk to animals, humans or the environment is identified. It can take place at various stages of marketing depending on the severity: stock of the manufacturer, agent or wholesale distributor, veterinarians and other beneficiaries, and even the owner of the animal in the event of a critical risk.

Batch recalls may also be proposed by the veterinary medicinal product operator or the entity responsible for placing the product on the market.

The medicinal product operator is responsible for the successful implementation of the batch recall and carries it out according to the terms defined by the Agency (type of messages to be disseminated, scope of the recall, etc.). 

If you have any questions about batch recalls, please contact the Agency at the following address: defautsqualiteMV@anses.fr

Regulatory references

Public Health Code (Art R.5141-45, R.5141-70, R.5141-136, R.5142-52).

Good Distribution Practice (Chapter 6): procedure for organising a recall, assessment of its effectiveness, rapid execution at all times.