VETERINARY MEDICINES GUIDELNES

NumberFile NameYear UpdatedVersionDocument TypeDownload
2.33ADR Reporting Post Marketing20206Guideline
2.48Veterinary Medicines Exemptions guidelines20201Guideline
3.14Veterinary Clinical Guideline20201Guideline
GL 1Validation of Analytical Procedures: Definition and TerminologyN/AN/AGuidelineTBC
GL 2Validation of Analytical Procedures: MethodologyN/AN/AGuidelineTBC
GL 3Stability Testing of New Veterinary Drug Substances and Medicinal ProductsN/AN/AGuidelineTBC
GL 4Stability Testing for New Veterinary Dosage FormsN/AN/AGuidelineTBC
GL 5Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal ProductsN/AN/AGuidelineTBC
GL 8Stability Testing for Medicated PremixesN/AN/AGuidelineTBC
GL 10Impurities in New Veterinary Drug SubstancesN/AN/AGuidelineTBC
GL 11Impurities in New Veterinary Medicinal ProductsN/AN/AGuidelineTBC
GL 17Stability Testing of New Biotechnological / Biological Veterinary Medicinal ProductsN/AN/AGuidelineTBC
GL 18Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and ExcipientsN/AN/AGuidelineTBC
GL 25Testing of Residual FormaldehydeN/AN/AGuidelineTBC
GL 26Testing of Residual Moisture N/AN/AGuidelineTBC
GL 45Quality – Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal productsN/AN/AGuidelineTBC
GL 51Statistical evaluation of stability dataN/AN/AGuidelineTBC
NumberFile NameYear UpdatedVersionDocument TypeDownload
GL 22Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction TestingN/AN/AGuidelineTBC
GL 23Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity TestingN/AN/AGuidelineTBC
GL 28Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity TestingN/AN/AGuidelineTBC
GL 31Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: Repeat-Dose (90 Days) Toxicity TestingN/AN/AGuidelineTBC
GL 32Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity TestingN/AN/AGuidelineTBC
GL 33Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to TestingN/AN/AGuidelineTBC
GL 37Guidance for Industry: Studies to Evaluate the Safety of residues of veterinary drugs in human food: Repeat-Dose Chronic toxicity testingN/AN/AGuidelineTBC
GL 54Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General approach to establish an acute reference dose (ARfD)N/AN/AGuidelineTBC
NumberFile NameYear UpdatedVersionDocument TypeDownload
GL 52Blood Level Bioequivalence StudyN/AN/AGuidelineTBC
NumberFile NameYear UpdatedVersionDocument TypeDownload
GL 43Target Animal Safety – Pharmaceuticals: Target Animal Safety for Veterinary Pharmaceutical ProductsN/AN/AGuidelineTBC
NumberFile NameYear UpdatedVersionDocument TypeDownload
GL 36Studies to Evaluate the Safety of residues of veterinary drugs in human food: General Approach to Establish a Microbiological acceptable daily intake (ADI)N/AN/AGuidelineTBC
GL 46Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Metabolism study to determine the quantity and identify the nature of residuesN/AN/AGuidelineTBC
GL 47Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animalsN/AN/AGuidelineTBC
GL 48Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periodsN/AN/AGuidelineTBC
GL 49Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Validation of analytical methods used in residue depletion studiesN/AN/AGuidelineTBC
GL 56Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods (draft: under consideration)N/AN/AGuidelineTBC
GL 57Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic speciesN/AN/AGuidelineTBC