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Product defect reports and recalls

A defective medical product in general circulation could have serious adverse health effects. Any company which markets a medical product in the Netherlands is obliged to report instances of defective quality to the Health Care Inspectorate and to the Medicines Evaluation Board. Reports can also be made by individual pharmacists.

On occasion, the Inspectorate may receive a report from a counterpart in another country. Together, these inspectorates are responsible for the quality of pharmaceutical products marketed throughout Europe, and hence possibly in the Netherlands. Each year, the Inspectorate analyses all incoming reports and establishes priorities for its inspection activities.
Upon receipt of a product defect report, an inspector will assess the risk to public health.

Because the product may have to be recalled immediately, at least one inspector is on duty at all times. A decision to recall the product is based on the classification of risk. This classification will also determine whether the recall is to be at the patient level or that of pharmacists and/or distributors, and whether inspectorates in other countries must be informed.

In many cases, a recall is considered unnecessary. If the Inspectorate is considering a recall, it will first consult the marketing authorisation holder. The Inspectorate does not order the recall: this is the responsibility of the marketing authorisation holder, although it is required to submit the recall notice for the approval of the Inspectorate. A recall notice must be sent out in a special 'Orange Hand’ envelope. Because these envelopes are used only for this purpose, pharmacists will immediately recognise their importance. The envelopes and the necessary mailing lists can be obtained from Nefarma.

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