GDP Non-Compliance Report for Austrian API Distributor
Register now for ECA's GMP Newsletter
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The Wholesale Distribution Authorisation (WDA) was withdrawn.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
16.01.2025EMA adds Considerations for Wholesale Distributors and Brokers on suspicious Offers
16.01.2025Swissmed informs about Control Campaign against illegal Trading in Medicinal Products
16.01.2025Two new PICS Documents on Remote Assessments published
16.01.2025The GDP Non-Compliance Reports of 2024 - An Overview
17.12.2024GDP in the US: Pre-posting of USP Chapter <1079.2> on MKT
17.12.2024Romanian Authority Issues further GDP Non-Compliance Report