Inspection Section is responsible according Act No. 378/2007 Coll., on pharmaceuticals, for following areas: issuing of manufacturing licence for veterinary medicinal products including medicated feedingstuffs and autogenous vaccines, and including variations of issued licences issuing of licences of control laboratories for testing of VMPs, including variations of issued licences issuing of distribution licences, including variations of issued licences issuing of certificates for manufacturers, control laboratories and distributors to confirm compliance with GMP or GDP principles performing inspections focused on compliance with Act No. 378/2007 Coll., on pharmaceuticals, and GMP, GDP and conditions defined in relevant licences publishing registers of relevant stakeholders praticipation in international activities
Inspection Section is according Act No. 166/1999 Coll., on veterinary care, also responsible for area of veterinary preparations: inspections focused on compliance with relevant parts of Act on veterinary care issuing of certificates for manufacturers of veterinary preparartions supervision in the filed of manufacture, placing on the market and using of veterinary preparations
This part of ÚSKVBL internet web pages is divided into five parts: distribution - you can find here forms, applications, guidances, templates aplicable for distribution of veterinary medicinal productsl, including registers of approved distributors, distribution sites, withdrawn licences manufacture and control of VMPs - forms, applications, guidances, EU GMP Guide in Czech language, templates aplicable for manufcature and control of veterinary medicinal productsl, including registers of approved manufactures and control laboratories, manufacturers of APIs manufacture of medicated feedingstuffs - specific guidance documents and forms, teplastes and registers valid for medicated feedingstuffs manufacture and control retail sale - documents, forms, tepmlates and guidance specific for retail sale of selected VMPs questions and answers - publishing of answers to the most frequent questions raised by stakeholders
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