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.
The necessity of a recall will depend on the risk classification, which will also determine whether a recall is to take place at wholesale, veterinarian/retail or end user level. A notification often does not require a recall.
If you observe a quality defect, you will report it via the notification form. The Veterinary Medicinal Products Unit will then arrive at agreements with you on the measures to be taken. If a quality defect could have consequences for humans, animals or the environment, you must contact the Veterinary Affairs Coordinator at the Veterinary Medicinal Products Unit immediately on 088 224 8040 or 06 52 75 63 44 (during and after office hours) or on general number 088 224 8000 if there is no answer on the first two numbers. You will be expected to report a situation of this nature via the notification form too.