Absence of Approved Storage Facilities leads to GDP Non-Compliance Report

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 dated 06 August 2021 into the EudraGMDP database.

According to the authority, during an inspection conducted on 15 June 2021 of a wholesale distributor located in Karviná, Czechia, it came out that the company does not comply with the Good Distribution Practice requirements referred to in Article 84 of Directive 2001/83/EC. As a consequence, the wholesale authorisation was suspended in full.

The report states that "the company does not provide approved storage facilities and the services of a qualified person are not ensured."

Source: EudraGMDP Database (Inspection Date: 15 June 2021; Report Number: sukls162731/2021) *

* 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.