GDP Non-Compliance Report for German Wholesale Distributor: RP is not Continuously Contactable

Recommendation

4/5 October 2023

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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:

• "Parts of the wholesale activities are conducted outside authorised premises that are not covered by a separate wholesale distribution authorisation."
• "The responsible person does not fulfil their responsibilities personally and is not continuously contactable. The deputy responsible person has not the appropriate competence and official approval and is not involved in all of the wholesale activities, especially the activities conducted outside the authorised premises."
• "The quality system does not ensure that the medicinal products procured, supplied, imported or exported in a way that is compliant with the requirements of GDP."

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.