1/2 March 2023
The competent authority of Germany (Trade and Industry Inspection Agency of State of Lower Saxony - Agency Lüneburg; Staatliches Gewerbeaufsichtsamt Lüneburg) has entered a new GPD Non-Compliance Report dated 21 July 2021 into the EudraGMDP database. The reasons for the report are critical violations of GDP requirements at a German wholesale distributor located in Hambühren.
During an inspection conducted on 06 July 2021, it came to light that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC. The severity of the violations led to a full suspension of the activities under the company's licence.
The authority lists the following three types of violations:
Source: EudraGMDP Database (Inspection Date: 6 July 2021; Report Number: DE GAALG 41403/085) *
* 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.