Two new GDP Non-Compliance Reports from Austria and Ireland published in the EudraGMDP database
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10/11 September 2025
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In recent weeks, two new violations of the EU GDP guidelines have been documented in the EudraGMDP database.
Austria
The first report, dated 19 May 2025 (Report Number: 482952-102672721), refers to an inspection conducted on 6 February 2025 and was entered into the database by the Austrian Federal Office for Safety In Health Care.
According to the report, the Vienna-based company does not comply with the GDP guidelines for medicinal products for human use. No specific details regarding the nature or extent of the deficiencies are provided. The Austrian authority has withdrawn the Wholesale Distribution Authorisation (WDA) and informed the concerned Member States.
Ireland
The second report (Report Number: 2024/35203/W13004/00001) was published on 4 June 2025 by the Irish Health Products Regulatory Authority (HPRA). It documents significant violations of several chapters of the EU GDP guidelines at a company based in Swords. In this case as well, the WDA was revoked.
The authority writes: "The company did not operate within the guidelines of EU Good Distribution Practice (GDP) in the activities relating to the procurement and supply of a specific product. This resulted in an increased risk of falsified medicines reaching patients. The holder failed to adhere to Chapters 4, 5, 7, and 9 of the EU GDP guidelines. A critical deficiency was identified in an inspection conducted on 24th July 2024, as the wholesaler was not operating within the terms of its Wholesale Distribution Authorisation (WDA). Following the inspection, the products in question were subject to a pharmacy level recall. The reason for the recall was that the products were not supplied in accordance with legal requirements and there was a lack of assurance that the packs had been under adequate cold chain temperature control during their transit to Ireland."
Source: EudraGMDP Database *
* 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.
