13/14 December 2023
On 09 October 2023, the Austrian Medicines and Medical Devices Agency has entered a new GPD Non-Compliance Report into the EudraGMDP database. The authority blames the wholesale distributor in question for a whole series of Good Distribution Practice (GDP) violations.
From the knowledge gained during an inspection performed on 03 October 2023, the authority came to the conclusion that the company does not comply with the GDP requirements. As a consequence, the Wholesale Distribution Authorisation (WDA) was withdrawn.
One aspect mentioned in the report is that the company performed several activities without permission:
Furthermore, the authority writes that the company does not comply with the EU GDP Guidelines for the following reasons:
Source: EudraGMDP Database (Inspection Date: 03 October 2023; Report Number: INS-484035-102397839). *
* 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.