In this section you will find:
- applications, annexes to applications and questionnaires for applicants for authorisation to manufacture veterinary medicinal products (VMPs), including authorisations within the scope of activities of the control laboratory, and for applicants for variations to authorisations,
- forms for applicants for the issue of a GMP certificate - intended for special applications outside the normal automatic GMP certificate issuance regime after a GMP inspection,
- forms for applicants for the issue of a manufacturer's certificate of active substances (API) for VMP,
- forms for manufacturers for notification of the start of production of a batch of veterinary autogenous vaccine (VAV), notification of the start of production of a batch of veterinary autochthonous convalescent serum (ARS) and notification of the start of production of a batch of autologous stem cells,
- veterinary prescription forms for the production of a veterinary autogenous vaccine (VAV), for the production of veterinary autochthonous convalescent serum (ARS) and for the production of a product containing autologous stem cells.
Documents are available in the form of forms - i.e. to be filled in in the parts intended for the applicant. The applicant shall attach annexes to each application in accordance with the list of annexes set out in his or her application.
In cases where the submission of an application is linked to the payment of an administrative fee and reimbursement of expenses for professional activities carried out on request pursuant to Section 112 of Act No 378/2007 Coll. on Pharmaceuticals, as amended, the applicant shall also attach pre-filled tax documents (Administrative fee receipt and Certificate of reimbursement of expenses for professional activities carried out within the scope of the ÚSKVBL), on which the ÚSKVBL shall acknowledge receipt of the payment and send them back to the applicant. Detailed information on payments can be found in the ÚSKVBL Guideline on administrative fees and reimbursement of expenses for professional activities carried out within the scope of the ÚSKVBL, available here.
Documents which are available only in Czech are at this link.