Reporting quality defects as a manufacturer or supplier of medicinal products
Vendors/licensees of medicinal products (manufacturers, importers, distributors, pharmacies, hospital pharmacies, dispending doctors) should report quality defects to medicinal products to the health care inspectorate. This also applies to medicinal products for research.
It concerns reporting quality defects to for instance the packaging, to the patient information or to the product itself. Together with the report, a recommendation for a recall can be done. This may include notifications in the field of Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP) and also of the combinations Medical Technology/GMP and Blood & Tissues/GMP.
Quality defects to national or de-centrally authorised products should be reported to the Dutch Health Care Inspectorate. Quality defects to centrally authorised products can be reported to the European Medicines Agency (EMA).
Rapid Alerts are initiated by the National Competent Authorities and/or the EMA.
Reporting
Enter your notification as soon as possible. To do this, use the digital notification form.
What happens with the notification?
Upon arrival of a defective quality report, an inspector assesses the risk to public health and decides whether a recall (recall) is necessary. Recalls are performed by the holder of the marketing authorisation. More information about the modus operandi at recalls.
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