A quality defect in a veterinary medicinal product on the market can have an impact on the efficacy of the veterinary medicinal product or public health to such an extent that a recall is required.
If you have detected a quality defect in a veterinary medicinal product, you must report this. You can read more about this on the page Reporting a product defect.
Reports of product defects arrive at the Veterinary Medicinal Products Unit via the manufacturer or marketing authorisation holder. Reports of product defects are also received from authorities abroad via a Rapid Alert Notification (RAN). EU member states use the RAN mechanism to inform each other about defects observed in veterinary medicinal products that may be on the market in multiple countries in Europe.
Whether or not a recall is required depends on the classification of the risk. (add link) The classification determines whether the recall is done at the level of the wholesale supplier, veterinarian/retailer or the end user. A notification often does not require a recall. If deemed necessary, the marketing authorisation holder or the manufacturer of the veterinary medicinal product coordinates the measures to be taken with the MEB's Veterinary Medicinal Products Unit via TaskforceGXP@cbg-meb.nl, tel: +31 (0)88-224-8040 or +31 (0)88-224-8569.