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

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 (Report Number: sukls162731/2021)

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