Each identified quality defect is assessed according to a procedure shared by the industry and ANMV. The risk assessment carried out successively by the two parties determines the criticality of the damage that the quality defect may cause to the health of the animals to be treated, or even indirectly to human health.

Procedure for managing quality defects and batch recalls (PDF).

A quality defect observed in one or more batches of a medicine is likely to lead to a batch recall, depending on the level of risk it represents, established by the manufacturer in application of the shared procedure. The recall is then proposed to Anses - ANMV by the MA holder or the person responsible for its marketing (RMM).

Veterinarians may also find a defect in a drug they administer or dispense. Quality defects observed by users themselves, whether veterinarians or animal owners, generally concern materially detectable non-conformities:

• an abnormal appearance of the product, before opening or on first use, in terms of color or consistency/viscosity in the case of a suspension, oral or intramammary paste, ointment, etc. ;
• the presence of visible particles (glass, colored particles) in an injectable or drinkable solution, the presence of a precipitate, a deposit on the walls or bottom of the container... ;
• drugs or devices breaking during use, during application or removal, or lost by animals during treatment;
• errors in the administration devices accompanying the product, such as an unsuitable dosing pump or the wrong solvent for a powder or lyophilisate...
• mislabeling concerning : 
  •  the exact name of the product;
  •  batch number discrepancies between outer packaging and label;
  •  dosage, target species, route of administration... ;
  •  the presence of an insert for another product, or one that does not comply with the current SPC;
  •  instructions or packaging not in French.

Exceptionally, a product may also appear to be an obvious counterfeit.Please note / the declaration of a quality defect must not be confused with that of an adverse reaction or a product efficacy defect. The latter must be reported to the Inspection, Surveillance and Pharmacovigilance Department of Anses-ANMV, using the specific form available on the Agency's website. 

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

 To declare a quality defect as a manufacturer

To declare a quality defect as a veterinarian/pharmacist

Batch recalls are proposed by the MA holder or the person responsible for placing the veterinary medicinal product on the market (TAMM / RMM), following a risk assessment of the quality defect, before being validated and notified by the Agency.

It may also be requested directly by the Agency, when a risk to the health of treated animals, or to humans or the environment, is identified by the Agency itself. 

Batch withdrawals can be carried out at various stages of the marketing process, depending on the extent of the risk involved: at the manufacturer's stock and RMM level, at wholesale distributor level, or even at the level of veterinarians and other entitled parties. In the case of the most critical risks, animal owners may also be informed.

The drug's TAMM/RMM is responsible for ensuring that the batch recall is carried out correctly, in accordance with the procedures defined with the Agency (nature of the messages to be disseminated, scope of the recall, etc.). 

If you have any questions about a batch recall, please contact the Agency at the following address DQ_ANMV@anses.fr

Regulatory references: 

Regulatory references:

Regulation (EU) 2019/6 of the European Parliament and of the Council, December 11, 2018, on veterinary medicinal products and repealing Directive 2001/82/EC.

French Public Health Code.

Current Good Manufacturing Practices and Good Distribution Practices.