product defects and recall

A quality defect in a veterinary medicine that is on the market can result in consequences for:

• the efficacy of the veterinary medicine, or;
• the protection of public health.

The marketing authorisation holder of a veterinary medicine – authorised by a national, MRP  or decentralised procedure - who markets a veterinary medicine in the Netherlands, or produces it as manufacturer, is obliged to report quality defects to the MEB – Veterinary Medicinal Products Unit – if the supply of a veterinary medicine will be limited or suspended as a result.

Qualitydefects on marketing authorisation with a centralised procedure should report this to the European Medicines Agency (EMA).

Others (e.g. animalkeeper, veterinarian or distributor of a veterinary medicine) should first report the detected qualitydefect to the authorisation holder or the manufacturer of the veterinary medicine, because they are required to implement an effective procedure for handling complaints and for the recall of defective products. If the receiver/ addressee doesn’t handle the information properly, this should be reported to the MEB, unit veterinary Medicinal Products.

The report of a quality defect to the MEB, unit Veterinary Medicinal Products should be submitted immediately and providing reasons, by using this reportform.

Reports are also received from foreign authorities. These so-called “Rapid Alerts” relate to veterinary medicines that are marketed in Europe and therefore possible also in the Netherlands.
Upon receipt of a report, the Veterinary Medicinal Products Unit together with the Health Care Inspectorate will immediately evaluate the risks to animal and public health. As veterinary medicines sometimes need to be withdrawn from the market as a matter of urgency, the report will be processed immediately.

The classification of the risc determines whether a recall is necessary. The classification also determines whether the recall takes place at the level of the veterinarian/retailer, or at a wholesale level and whether or not foreign authorities will be informed by means of a Rapid Alert.

Contact details

Vetpharvig@cbg-meb.nl
Tel: +31 (88) 224 8234 / +31 (88) 224 8238