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anses

French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 08/04/2020

Quality defect in a veterinary medicinal product

The veterinary medicinal product manufacturer ensures the quality of each batch before placing it on the market. However, there may be occasions when the manufacturer only becomes aware of an incident that occurred during manufacture or distribution after the medicinal product has been marketed. If the medicinal product does not comply with its marketing authorisation, this is known as a quality defect.

The quality defect may be observed on one or more batches of the medicinal product and is liable to lead to a batch recall. This is reported to ANSES-ANMV by the pharmaceutical company responsible for placing it on the market (the operator).

  • Quality defect reporting form for the operator: here

The quality defect is assessed according to a procedure shared between the ANMV and industry. The risk assessment determines the criticality of the damage that the quality defect in the medicinal product could cause to animal or even human health.

  • Procedure for managing quality defects and batch recalls of a veterinary medicinal product: here

The veterinarian may also find a defect on the units he/she administers or dispenses. These quality defects observed by the users themselves, whether veterinarians or animal owners, mainly concern materially detectable defects:

  • An abnormal appearance, before opening or during the first use of the product, in the colour or consistency-viscosity in the case of a suspension, oral/intramammary paste, ointment, etc.;
  • The presence of particles in an injectable or drinkable solution (glass, black particles), or a precipitate or deposit on the walls or bottom of the container;
  • Veterinary medicinal product devices that break during use, application or removal, or are lost by animals during treatment; errors in delivery devices accompanying the product, such as an unsuitable dosing pump or a poor solvent for a powder or lyophilisate;
  • Labelling defects concerning:
    • The exact name of the product;
    • A difference in batch number between the one on the outer packaging and the one on the label;
    • The dosage, target species or route of administration;
    • The leaflet of another product, or one that does not comply with the SPC or has not been updated;
    • Leaflet or packaging that is not in French.

A product may also, exceptionally, present itself as an obvious counterfeit.

Faced with such findings, the practitioner should in every case and in the first instance contact the pharmaceutical company responsible for placing the medicinal product on the market, whose contact information is on the packaging. He/she may also notify ANSES-ANMV, depending on the seriousness of the finding or the need for information or rapid action, or in the event of a lack of response from the pharmaceutical company.

  • Quality defect reporting form for the veterinarian/pharmacist: here

Your attention is drawn to the fact that reporting a quality defect should not be confused with reporting an adverse reaction (serious or not) or a lack of efficacy. This should be reported to the ANSES-ANMV Pharmacovigilance Department using the specific form provided on the Agency's website.

All reports of quality defects should be sent to the Inspection and Market Surveillance Department via the email address: defautsqualitéMV@anses.fr.

Regulatory references

Good Manufacturing Practice (Chapter 8): obligation to report to the Director General of ANSES any quality defect after batch release.