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14/02/2022

Quality defects and batch recall of a veterinary medicinal product

The manufacturer of veterinary medicinal products shall ensure the quality of each batch before placing it on the market. However, it may not become aware until after marketing of an incident which occurred during the manufacture or during the distribution of the medicinal product. If, as a result, the medicinal product does not comply or no longer complies with its marketing authorisation, it is referred to as a quality defect.  

A batch reminder is envisaged following the identification of a quality defect, but also of a pharmacovigilance problem or following a decision to suspend/withdraw the marketing authorisation or temporary authorisation for use.

Quality defect of a veterinary medicinal product

A quality defect is assessed according to a procedure shared between ANMV and Industry. The risk assessment carried out by both parties makes it possible to determine the criticality of the damage to animal or even human health caused by the lack of quality presented by the medicinal product.
Procedure for management of quality defects and batch recalls of a veterinary medicinal product (PDF)

The quality defect observed in one or more batches of medicinal products may lead to a batch recall. This reminder is then proposed to Anses-ANMV by the laboratory responsible for placing it on the market (operator). 

A veterinarian may also detect a defect in one or more units which he is required to administer or issue. The quality defects found by users themselves, veterinarians or animal owners, mainly concern physically detectable non-conformities :

  • an abnormal appearance, before opening or when the product is first used, on the colour or consistency/viscosity in the case of suspension, oral/intramammar paste, apple, etc...;
  • the presence of particles in an injectable or oral solution (glass, black particles) or a precipitate, a deposit on the walls or at the bottom of the container; 
  • medicinal products or devices that break during use, during installation, removal, or lost by animals during treatment; Errors in administration devices accompanying the product, such as an inappropriate dosing pump or a bad solvent for a powder or lyophilisate...
  • loss of labelling relating to: 
    • the exact name of the product;
    • a difference in batch number between that on the external packaging and that on the label;
    • detection, target species, route of administration;
    • the package leaflet of another product, or not in conformity with the SmPC or not updated; 
    • notice or packaging which is not in French;
    • a product may also, exceptionally, be presented as a manifest infringement.

A product may also, exceptionally, be presented as a manifest infringement. 

Your attention is drawn to the fact that the declaration of a quality defect should not be confused with the declaration of an adverse reaction (serious or not) or a lack of efficacy of the product. This must be declared to the Anses-ANMV Inspection, Surveillance and Pharmacovigilance Department using the specific form, made available on the Agency’s website

If you have any questions about a quality defect, you can contact the Agency at the following address: DQ_ANMV@anses.fr 

Regulatory references: Good Manufacturing Practices (Chapter 8): Obligation to notify the Director-General of Anses of any quality defect after release of the lot.


To declare a defect quality as an industrial 

Batch recall of a veterinary medicinal product

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

Regulatory references

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.