Authorisation of activities related to Good Manufacturing Practice (GMP) for veterinary medicinal products (VMP)

In this section you will find documents and information for the following areas:

• GMP requirements for the production of VMP (including information for the production and prescription of veterinary autogenous vaccines (VAV), veterinary autochthonous convalescent sera (ARS) and autologous stem cells),
• GMP requirements for the production of active substances (API) for VMP,
• authorisation of production of VMP and authorisation of production of VLP in the scope of quality control (control laboratories),
• certification of manufacturers of API for VMP.

The section is divided into:

Guidelines and information - GMP guidelines of the EU GMP and other specifying guidelines of the USKVBL issued pursuant to Act No. 378/2007 Coll., on Pharmaceuticals, as amended.

Forms - applications for issuing authorisations or amending authorisations for individual types of activities, annexes to these applications (questionnaires, etc.).

Contact persons for GMP are: Mgr. Hana Jiřikovská (This email address is being protected from spambots. You need JavaScript enabled to view it., +420 541 518 274) and MVDr. Martin Jůza (This email address is being protected from spambots. You need JavaScript enabled to view it., +420 541 518 273). (Please note: official requests must always be sent only through the mailroom of the USKVBL)