FMEB and IGZ
On January 2nd 2017, the Medicine shortages and defects notification centre went live. The centre is coordinated by the Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ).
Via one central point, marketing authorisation holders and manufacturers can 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
- A possible shortage because a medicinal product is being placed on the market in smaller quantities
- A quality defect in relation to a medicinal product
Please keep in mind that as stipulated in Article 49 of the Dutch Medicines Act marketing authorisation holders and manufacturers are obliged to report the availability on the market and (possible) shortages of a medicinal product.