GDP Non-Compliance Report due to GDP Violations concerning RP, Supplier Qualification, Operations and Trading
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The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 18 January 2022 into the EudraGMDP database.
On 12 January 2022, the authority inspected a company located in North Rhine-Westphalia, Germany. During that inspection, it came to light that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC.
In the report, the authority lists the following four deficiencies:
- "no responsible person who possesses the required expert knowledge
- the wholesaler is unable to guarantee that the regulations governing proper operations are being observed
- missing qualification of suppliers and customers
- trading of medicinal products which are not included in wholesale authorisation"
As a consequence, the wholesale authorisation was suspended.
Source: EudraGMDP Database (Inspection Date: 12 January 2022; Report Number: 24.05.17-07-0030) *
* 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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