Not Approved Storage Facilities lead to GDP Non-Compliance Report for Czech Wholesale Distributor
Recommendation
9 September 2025
Basel, Switzerland
Specifics in the Distribution of Medicinal Products
Register now for ECA's GMP Newsletter
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.
Related GMP News
10.06.2025Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)
10.06.2025New MHRA Blog Post: Supplying Medicines to Ships, Aircraft and Oil Platforms
10.06.2025Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 3
10.06.2025Meet the GDPA Board Members at the GDP Forum in Barcelona
10.06.2025Swissmedic Technical Interpretation: What Counts as a Major Change in GDP?
10.06.2025MHRA informes about Validity Date of UK issued GDP Certificates