GDP Non-Compliance Report for Belgian Wholesale Distributor

Recommendation

13/14 December 2023

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End of October 2022, the Competent Authority of Belgium (Federal Agency for Medicines and Health Products) added a new GDP Non-Compliance Report to the EudraGMDP database.

The document dated 21 October 2022 goes back to an inspection conducted on 07 October 2022 at a wholesale distributor in Bierbeek, Belgium.

The authority blames the company in question for a whole series of GDP violations:

• "Importation of medicinal products without importation authorization
• sales of medicinal products to non-authorized societies
• holding of medicinal products in non-authorized rooms
• distribution of API without API registration
• RP does not properly perform his or her duties"

As a consequence, the wholesale distribution authorisation (WDA) was suspended.

Source: EudraGMDP Database (Inspection Date: 07 October 2022; Report Number: BE/NC/2022/03). *

* To find the respective report, please click on "Non-Compliance Reports" in the menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.