The State Institute for Drug Control (SUKL) outlined its concerns about First Pharma s.r.o, Duchcovská distribucní s.r.o and WebCash s.r.o in reports posted on the EudraGMDP website.
All the firms are accused of breaching GDP guidlines set out in Article 84 of Directive 2001/83/EC, however, the inspectors only provide details of violations observed at the WebCash facility in Zlin.
According to the report, WebCash does not use authorized storage facilities. The document also states the firm failed “to ensure the services of a qualified person.”
Under GDP a “responsible person should be appointed by the management for each distribution site, who should have defined authority and responsibility for ensuring that a quality system is implemented and maintained.”
SUKL did not respond when we asked if the term “qualified person” had been used in error.
The agency suspended all three firms’ distribution licenses.
Non-compliance
GDP con-compliance reports are rare.
The three posted by SUKL are the only documents added to the EudraGMDP database this year.
The next most recent report – which was also posted by the Czech regulator – was made public last August.
UPDATE
SUKL spokeswoman Hana Pavlíčková told us "in the Czech Republic is the term 'qualified person' used in compliance with § 76 section 1 letter b) of the Act No. 378/2007 Coll., On Pharmaceuticals and therefore the qualified person is also the responsible person in compliance with EU instructions for GDP.
"At this moment, the term 'responsible person' means a person that is responsible for addictive substances."