GDP Non-Compliance Report for Austrian Wholesale Distributor

Recommendation

13/14 December 2023

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On 09 October 2023, the Austrian Medicines and Medical Devices Agency has entered a new GPD Non-Compliance Report into the EudraGMDP database. The authority blames the wholesale distributor in question for a whole series of Good Distribution Practice (GDP) violations.

From the knowledge gained during an inspection performed on 03 October 2023, the authority came to the conclusion that the company does not comply with the GDP requirements. As a consequence, the Wholesale Distribution Authorisation (WDA) was withdrawn.

One aspect mentioned in the report is that the company performed several activities without permission:

• Selling products (products with special requirements are not covered by the authorisation);
• Exporting medicinal products (export is not covered by the authorisation);
• Buying medicinal products from companies outside the EEA (the company does not hold an authorisation to import medicinal products from third countries).

Furthermore, the authority writes that the company does not comply with the EU GDP Guidelines for the following reasons:

• Qualification of suppliers and supply is not in compliance with the Guideline;
• An effective quality system is not maintained;
• The Responsible Person doesn't have appropriate competence and experience as well as knowledge of GDP and doesn't carry out her duties in such a way as to ensure that the distributor demonstrates GDP compliance.

Source: EudraGMDP Database (Inspection Date: 03 October 2023; Report Number: INS-484035-102397839). *

* 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.