GDP Non-Compliance Report for Belgian Wholesale Distributor
![GDP in Switzerland (GDP 3)](files/eca/userImages/training.img/Z-GDP3-GDP-in-Switzerland-neues-Layout.jpg)
Recommendation
12 September 2024
Basel, Switzerland
Specifics in the Distribution of Medicinal Products (Course in english language!)
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
16.07.2024Templates for Shortage Prevention and Mitigation Plans issued by EMA
16.07.2024New Measures to Report Medicine Disappearances
16.07.2024GDP Non-Compliance Report for Czech Wholesale Distributor
16.07.2024Checklist for Implementation of GDP Principles - Part 9: Transportation
12.06.2024EU adopts Supply Chain Law - Implications for pharmaceutical Companies