Not Approved Storage Facilities lead to GDP Non-Compliance Report for Czech Wholesale Distributor

Recommendation

13/14 December 2022

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The competent authority of Czechia (State Institute for Drug Control) has entered a new GPD Non-Compliance Report into the EudraGMDP database.

During an inspection conducted in November 2020 at a Czech wholesale distributor, it came out that the company does not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC. As a consequence, the wholesale permission was suspended.

According to the Czech authority, "the company 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. [...] The WDL was suspended in full due to the fact, that the company does not provide approved storage facilities."

Source: EudraGMDP Database (Inspection Date: 11 November 2020; Report Number: sukls268540/2020) *

* 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.