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Authorisation and approval

Welcome to the marketing authorisation and approval section where we would like to give you all important information about the marketing authorisation of veterinary medicinal products in the Czech Republic and EU. Application forms and regulatory guidelines issued by the ISCVBM incl. links to guidelines issued by European Commission, EMEA and VICH are available for applicants/MAH holders in this section too.

Further you will find here information about an approval procedure for borderline products, registration of veterinary devices, approval of clinical trials and biocidal products.

The section includes the questions and answers page that addresse a number of questions that have been brought to the attention of ISCVBM by Marketing Authorisation Holders (MAHs) on matters related to the marketing authorisation. The list of questions is continuously updated.

Authorisation and approval