GDP Non-Compliance Report for Austrian API Distributor
Recommendation

8 September 2026
Basel, Switzerland
Specifics in the Distribution of Medicinal Products
The Austrian Agency for Health and Food Safety has entered a new GDP Non-Compliance Report dated 07 December 2023 into the EudraGMDP database. During an inspection, it came out that an active substance (API) distributor located in Vienna does not comply with the GDP principles for active substances.
The authority writes that "all registered active substances distributed are affected" and that "concerned member states are informed".
The Wholesale Distribution Authorisation (WDA) was withdrawn.
Source: EudraGMDP Database (Inspection Date: 31 August 2023; Report Number: 481791-101212189). *
* 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
14.07.2026USP Proposes to Revise the Definition of Controlled Room Temperature in Chapter <659>
14.07.2026GDP in Hong Kong: Authority Provides Additional Information
14.07.2026GDP Inspection Responses: MHRA’s Expectations for AI Use in GxP Replies
14.07.2026FDA Warning Letter to Amazon: Unapproved New Drugs Sold via Online Marketplace
18.06.2026GDPA Participated as an Observer in the EMA GMDP-IWG Interested Parties Meeting


