Order No. 7-1/625 of the Minister of Agriculture validating the Regulation on coordination of normative and technical documentation for new, improved veterinary drugs, feed additives.

This Order sets forth the procedure for coordinating by natural and legal persons of normative and technical documentation for new, improved veterinary drugs, and feed additives. The applicant must submit to the competent authority application containing the following information and data: (a) standard of the requiring entity and (or) international standards in accordance with the Annex 1; (b) instructions for the manufacturing and control of veterinary drugs and feed additives, signed/approved by the developer of the veterinary drug, feed additive (physical person or a director of a legal entity) in accordance with the Annex 2; (c) guidance (instruction) on the use of veterinary drug, feed additives, elaborated by the developer, in accordance with the Annex 3; (d) certificate for manufacturing and control strains of microorganisms and for transferable cell culture lines in accordance with the Annex 4; (e) document attesting registration of veterinary drug, feed additives and (or) insertion in state official pharmacopoeia of third countries, except for the member countries of the Customs Union and Common Economic Area (if available); (f) notarized copy of the contract between the manufacturer and the patent holder for the components of a veterinary drug, feed additive, in case of availability of a patent(s) for individual components of the veterinary drug, feed additive (strains of microorganisms, used to manufacture/control a veterinary drug, feed additive) or for technology/method of making a veterinary drug, feed additive, or for its use/application; and (g) report of a scientific research institution.