Regulations

📎The Law of Ukraine “On Veterinary Medicine” (in Ukrainian)

📎State Pharmacological Commission (Article 61) Law of Ukraine “On Veterinary Medicine” (in Ukrainian)

📎Resolution of the Cabinet of Ministers of 21 November 2007 N 1349 (On Approval of Regulations on State Registration of Veterinary Medicinal Products, Feed Additives, Premixes and Finished Feeds) (in Ukrainian)

📎Order No. 133 dated 14.07.2008 “On Approval of Application Forms, Text Information on Packaging (Labelling), List of Materials of Registration Dossier and Procedure for its Formation” (in Ukrainian)

📎Order No. 606 dated 10.11.2018 “On Approval of the Regulation on Basic Requirements for the Production of Veterinary Medicinal Products and the Rules of Good Manufacturing Practice for Veterinary Medicinal Products” (in Ukrainian)

📎Registration scheme (in Ukrainian)

📎Applicant’s notebook (in Ukrainian)

📎”Dossier of the Veterinary Medicines Manufacturer’s Site” Guidelines. (in Ukrainian)

📎Methodological recommendations on the procedure for conducting pharmacokinetic equivalence (bioequivalence) tests of veterinary drugs (in Ukrainian)

📎”Procedure For Confirming The Conformity Of Veterinary Drugs Production With The Requirements Of Good Manufacturing Practice (GMP)” (DRAFT in Ukrainan)

📎International harmonisation and cooperation (VICH)

📎International requirements for determining the efficacy of antiparasitic drugs for different animal species (VICH)