Tuesday, 11 May 2021 14.00 - 15.30 h
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 (Report Number: sukls268540/2020)