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Inspections

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for distribution of veterinary medicinal productsl, including registers of approved distributors, distribution sites, withdrawn licences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


Inspections