Documents to be Submitted

The procedure to be followed for obtaining a special permit (licence) is specified in Cabinet Regulation No. 35 of 11 January 2011, Procedures for the Issuing, Suspension, Re-Registration and Revoking of Special Permits (Licences) for Veterinary Pharmaceutical Activity. A person in whose name the issue of a special permit (licence) is planned, shall first submit the following to the Food and Veterinary Service (hereinafter - FVS) at the head office or a territorial unit:
 
  • an application for the issue or re-registration of a special permit (licence) for the manufacturing and import of a veterinary medicinal product (Annex No. 1),
  • description of the manufacturing site (Annex No. 2),
  • if the veterinary medicinal products are manufactured exclusively for exporting, the list of manufactured veterinary medicinal products that are intended for export (Annex 3).
 
Review time of the Application:
 
  • FVS shall review the application for the issue or re-registration of a special permit (licence) for the manufacturing or import of veterinary medicinal products and the documents enclosed with the application within 5 business days. If additional information is required during the examination of the documents, it shall be requested from the applicant.