Competent Authority of Austria issues new GDP Non-Compliance Report

Recommendation

13/14 December 2023

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The Austrian Medicines and Medical Devices Agency has entered a new GPD Non-Compliance Report into the EudraGMDP database.

In the document dated 09 October 2023, the authority writes that "major deficiencies were detected in quality systems also related to the lacking awareness of the responsible person." As a consequence, the Wholesale Distribution Authorisation (WDA) for human and veterinary medicinal products was withdrawn.

According to the authority, the company located in Salzburg was operating in Austria only. Therefore, no further member states are affected.

Source: EudraGMDP Database (Inspection Date: 13 October 2021; Report Number: INS-482779-14059355). *

* 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.