GDP Non-Compliance Report for Belgian Wholesale Distributor
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
16.01.2025EMA adds Considerations for Wholesale Distributors and Brokers on suspicious Offers
16.01.2025Swissmed informs about Control Campaign against illegal Trading in Medicinal Products
16.01.2025Two new PICS Documents on Remote Assessments published
16.01.2025The GDP Non-Compliance Reports of 2024 - An Overview
17.12.2024GDP in the US: Pre-posting of USP Chapter <1079.2> on MKT
17.12.2024Romanian Authority Issues further GDP Non-Compliance Report