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
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
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
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medicines sometimes need to be withdrawn from the market as a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.
Tel: +31 (88) 224 8234 / +31 (88) 224 8238