Order No. 137 of the State Committee of Veterinary Medicine validating application forms, text information on packaging (marking), and list of materials on registration dossier and order of its formation.

The registration dossier must contain an administrative part and sections that regulate the quality, safety and efficacy of the veterinary drug. The dossier shall be written in Ukrainian or English, and Sections A and B of Part I must be written exclusively in Ukrainian. The dossier should be clearly divided into sections, all pages should be numbered. Each volume of a dossier is numbered in Arabic numerals, marked with a brochure and must have a clear identification. If the dossier is accompanied by graphic material, it must be clear, presented in the required number with the necessary descriptions and explanations. At the end of each section of the registration dossier, a conclusion is presented, which sets out the summary of the section with links to the registration dossier pages. The dossier must contain full copies of all bibliographic references, if necessary, it is necessary to submit their translations. The registration dossier for veterinary drugs consists of four parts: Part I. Administrative; Part II. Chemical, pharmaceutical and biological documentation; Part III. Documentation confirming the safety and acceptable level of residues of the Preparation in livestock products; Part IV. Preclinical and clinical documentation. The registration dossier for veterinary immunobiological drugs consists of five parts. Part I. General characteristics. Part II. Analytical (physic-chemical, biological or microbiological) research methods of the VIP. Part III. Investigation of harmlessness. Part IV. Efficiency study. Part V. Additional information. The registration dossier for feed additives (premixes) for non-productive animals consists of four parts: Part I. Administrative; Part II. Chemical, pharmaceutical and biological documentation; Part III. Documentation confirming the safety of the feed additive (premix); Part IV. Preclinical and clinical documentation.