Competent Authority of Austria issues new GDP Non-Compliance Report
Register now for ECA's GMP Newsletter
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 As a consequence, the Wholesale Distribution Authorisation (WDA) for human and veterinary medicinal products was withdrawn.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.
Related GMP News
10.06.2025Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)
10.06.2025New MHRA Blog Post: Supplying Medicines to Ships, Aircraft and Oil Platforms
10.06.2025Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 3
10.06.2025Meet the GDPA Board Members at the GDP Forum in Barcelona
10.06.2025Swissmedic Technical Interpretation: What Counts as a Major Change in GDP?
10.06.2025MHRA informes about Validity Date of UK issued GDP Certificates