German Authority issues new GDP Non-Compliance Report

The competent authority of Germany (Bezirksregierung Koeln) has issued a new GDP Non-Compliance Report in the EudraGMDP database. During a reinspection at a wholesale distributor in Cologne conducted on 18 April 2024, it was found that the issues from the inspection on 19 October 2023 had not been resolved. Furthermore, new critical and serious findings were identified.

The company's activities included procurement, holding, supply, export, and transportation of human medicinal products. 

In the report dated 29 July 2024, the authority stated that the inspections revealed that the company did not meet Good Distribution Practice (GDP) standards. Specifically, there were issues with customer and supplier qualification systems, verification checks, and transportation of medicinal products. Additionally, inadequate documentation and non-compliance in outsourced activities were identified.

As a result, the wholesale distribution authorization was suspended on 02 January 2024, and later revoked on 17 July 2024.

Source: EudraGMDP Database (Inspection Date: 18 April 2024; Report Number: DE_NW_04_NonCompliance_2023-0023). *

* 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.