GDP Non-Compliance Report due to Lack of Authorized Storage Facilities

The Competent Authority of Czechia (State Institute For Drug Control) has entered a new GDP Non-Compliance Report into the EudraGMDP database.

In the report dated 13 November 2023, the authority writes that from the knowledge gained during an inspection on 23 October 2023, the wholesale distributor "has seriously violated the conditions on which is the permission for activities linked and fell short of the obligations set out in Section 76 of the Act on Pharmaceuticals by failing authorized storage facilities."

The wholesale authorisation was suspended.

Source: EudraGMDP Database (Inspection Date: 23 October 2023; Report Number: sukls67268/2023). *

* 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.