GDP Non-Compliance Report: No Responsible Person, proper Storage and Distribution not ensured
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The Competent Authority of Germany (Landesamt Fuer Gesundheit Und Soziales Mecklenburg Vorpommern) has entered a new GDP Non-Compliance Report into the EudraGMDP database.
In the report dated 16 April 2025, the authority writes that from the knowledge gained during an inspection on 15 April 2025, the following nature of GDP non-compliance was observed at a wholesale distributor located in Schwerin:
- "The wholesale distributor can not designate a responsible person.
- Furthermore, there are no suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products.
- The NCA was unable to carry out an inspection in accordance with § 64 of the Medicinal Products Act."
The wholesale authorisation was suspended. The suspension of the WDA is limited to two months. After this time, the WDA will be revoked.
Source: EudraGMDP Database (Inspection Date: 15 April 2025; Report Number: NC/410.0410/2025). *
* 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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