Competent Authority of Czechia issues four new GDP Non-Compliance Reports

Recommendation

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After the public access to the GDP Non-Compliance Reports in EudraGMDP did not function for several weeks, reports can now be accessed again. In the meantime, four new documents have been added, all from the competent authority of Czechia (State Institute for Drug Control).

Wholesale Distributor in Ostrava

One of the reports (report number: sukls32154/2023, issue date: 09 February 2023) is about a wholesale distributor from Ostrava. From the knowledge gained during an inspection of this wholesale distributor, the authority came to the conclusion that "the company has seriously violated [the GDP requirements] by failing authorized storage facilities." 

Wholesale Distributor in Opava

The second report (report number: sukls39183/2023; issue date: 15 February 2023) relates to a company in Opava. Also in this case, the authority writes that the firm has seriously violated the GDP requirements by failing authorized storage facilities.

The additional comments section of the report states that "The WDL was suspended in full due to the fact, that the company does not provide approved storage facilities and the services of a qualified person are not ensured."

Wholesale Distributor in Prague

The other two reports (report number: sukls223529/2022; issue date: 27 January 2023 / report number: sukls22447/2023; issue date: 01 February 2023) both refer to the same wholesale distributor. The company's wholesale distribution authorisations (WDLs) were suspended in full due to the fact that the company does not provide authorized/approved storage facilities.

Access to GDP Non-Compliance Reports

To find the respective reports, please go to the EudraGMDP Database and 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. The latest inspections of the above mentioned wholesale distributors took place in October/November 2022. After clicking on "Search" the results list will be displayed, from which you can choose the report with the numbers mentioned above.