GDP Non-Compliance Report for Czech Wholesale Distributor
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The competent authority of Czechia (State Institute for Drug Control) has entered a new GDP Non-Compliance Report into the EudraGMDP database, marking the first report published in 2024.
The report dated 27 June 2024 goes back to an inspection conducted on 31 May 2024 at the site in Prague. This inspection uncovered serious violations of GDP requirements as specified in Article 84 of Directive 2001/83/EC.
The report details: "The company has seriously violated the conditions on which is the permission for actvities linked and fell short of the obligations set out in Section 76 of the Act of Pharmaceuticals by failing to ensure the services of a qualified person." It is unclear whether the term "qualified person" is being used correctly, or whether the "responsible person" is actually meant.
As a result, the company's wholesale authorization has been withdrawn.
Source: EudraGMDP Database (Inspection Date: 31 May 2024; Report Number: sukls49149/2024). *
* 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.
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