GDP Non-Compliance Report for Belgian Wholesale Distributor
Recommendation
14-16 May 2025
Vienna / Schwechat, Austria
Two-day training + 1-day Airport tour at Vienna Airport in cooperation with DHL
Register now for ECA's GMP Newsletter
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.
Related GMP News
23.04.2025MHRA Class 2 Recall due to Blister Pack Mislabeling
15.04.2025Falsified Medicinal Products: Swissmedic Intensifies Controls on International Trade
15.04.2025EMA's 3-Year Work Plan for GMDP Inspectors Working Group: What's Planned for GDP?
15.04.2025Two GDP Non-Compliance Reports published in March
15.04.2025Visit the DHL Vienna Airport Campus
15.04.2025Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 1