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Non-compliance report with respect to GDP issued in EudraGMDP by Czech Republic

The competent authority of the Czech Republic issued three GDP non-compliance reports to three companies which were entered into the community database for GMP and GDP compliance. While GMP Non-Compliance Reports are entered frequently, reports about GDP compliance issues are not published very often.

The first concerned company is First Pharma s.r.o. The warehouse is in Alliance Healthcare s.r.o., Podle Trati c.p. 624/7, Praha 10 - Malešice, 108 00, Czech Republic. During the inspection of the company the inspectors found that it does not comply with the Good Distribution Practice requirements referred to in Article 84 of Directive 2001/83/EC." No further details have been published about the details of the findings. The second company is Duchcovská distribucní s.r.o., Nemocnicní 264, Duchcov, 419 01, Czech Republic for which the details have not been provided about the reasons of the GDP Non-Compliance.

The third company is WebCash s.r.o., warehouse is in Námestí Práce 1099/1, Zlín, 760 01, Czech Republic. According to the report the company failed to use authorized storage facilities. Also the company has not ensured "the services of a qualified person". This might be translation error because a Qualified Person is not needed for a GDP facility but a "Responsible Person". The wholesale authorization was suspended for all three companies.


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