A quality defect or product defect of a veterinary medicinal product on the market can have an impact on the efficacy of the veterinary medicinal product or public health. Reporting a product defect is therefore important in order to monitor the continuous quality of veterinary medicinal products.
Reporting a product defect as a marketing authorisation holder
If you are a marketing authorisation holder or a manufacturer of a veterinary medicinal product and discover or suspect that it does not meet the requirements or may endanger the health of humans or animals or the environment, you must report this immediately to the MEB Agency, Veterinary Medicinal Products Unit. You can use the notification form for this (add link).
Quality defects affecting centrally authorised veterinary medicinal products must be reported via the website of the European Medicines Agency (EMA).
When a report is received, the risks to animal and public health are assessed in consultation with the 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. Read more about the recall of a veterinary medicinal product.
Reporting a product defect as a livestock holder, veterinarian or distributor
If you are a livestock holder, veterinarian or distributor and you have detected a quality defect in a veterinary medicinal product (you did not cause yourself), report this immediately to the marketing authorisation holder. This is stated on the label and/or in the package leaflet of the veterinary medicinal product.
The marketing authorisation holder must have a proper system for handling complaints and quality defects about veterinary medicinal products and for the quick withdrawal of veterinary medicinal products from the market.
If you are dissatisfied with the way your report or complaint about the quality defect of a veterinary medicinal product was handled by the Marketing Authorisation Holder, you can also report this via the contact form to the Veterinary Medicinal Products Unit. We then handle this report further, discuss it with the enforcement parties and contact the relevant marketing authorisation holder, if necessary.
Reporting a general complaint
If you have a general complaint about veterinary medicinal products or the Veterinary Medicinal Products Unit, you can submit it by telephone or in writing. For more information, consult the page Suggestions and complaints handling.
If your complaint is not dealt with satisfactorily, you can also submit your complaint by email via email@example.com. You should indicate as clearly as possible what the complaint is about and whether you have had any previous contact in that regard with the Veterinary Medicinal Products Unit.