Product defects and recalls of veterinary medicinal products

A quality defect in a veterinary medicinal product that is on the market can have consequences for the efficacy of the veterinary medicinal product or for public health interests.

Anyone who markets a veterinary medicinal product in the Netherlands (the holder of the marketing authorisation as stated on the label) or produces it as the manufacturer must report any quality defects to the Veterinary Medicinal Products Unit if the supply of a veterinary medicinal product is restricted or halted as a result.

Quality defects affecting centrally authorised veterinary medicinal products can be reported via the website of the European Medicines Agency (EMA).

Others (for example a livestock farmer, veterinarian or a distributor of veterinary medicinal products) must in the first instance report the quality defect observed to the marketing authorisation holder or manufacturer of the veterinary medicinal product, because they must have a proper system for both handling complaints about veterinary medicinal products and for withdrawing such products from the market quickly. If the recipient of this notification does not deal with it correctly, the matter can be presented to the Veterinary Medicinal Products Unit using the contact form.

The report of the quality defect should be submitted immediately, stating the reasons, using the notification form.

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 other countries in Europe.

When a report is received, the risks for animal health and public health are assessed, working with the Dutch Health and Youth Care Inspectorate (IGJ). Because a veterinary medicinal product sometimes has to be recalled urgently from the market, the report will be handled immediately.

Whether or not a recall is required depends on the classification of urgency. The classification also determines whether the recall is done at the level of the veterinarian/retailer or of the wholesale supplier. A notification often does not require a recall. If it is deemed necessary, the marketing authorisation holder or the manufacturer of the veterinary medicinal product agrees the measures to be taken with the MEB’s Veterinary Medicinal Products Unit via taskforcegxp@cbg-meb.nl, telephone number +31 (0)88-224-8040 or +31 (0)88-224-8569.