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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. The usability of the form has been optimised on the basis of feedback from users.

Marketing authorisation holders and manufacturers can visit the notification centre to submit the following notifications:

  • A medicinal product is placed on the market for the first time, or again following an interruption;
  • The marketing of a medicinal product is being discontinued or interrupted (including a possible shortage);
  • A possible shortage because a medicinal product is being placed on the market in smaller quantities or to an insufficient degree;
  • A quality defect in relation to a medicinal product.

A notification form is available to report the above. You can find additional details and a clarification of the notification procedures in the user guide.

Coordination 
The Medicine shortages and defects notification centre is coordinated by the Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ). The notification centre is commissioned by the Ministry of Health, Welfare and Sport (VWS).

More information
Medicine shortages and defects notification centre

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.