-
QUALITY GUIDELINES
-
TOXICOLOGY GUIDELINES
-
EFFICACY GUIDELINES
-
SAFETY GUIDELINES
-
MRLS, RESIDUES AND WITHDRAWAL PERIODS GUIDELINES
| Number | File Name | Year Updated | Version | Document Type | Download |
|---|---|---|---|---|---|
| 2.33 | ADR Reporting Post Marketing | 2020 | 6 | Guideline | Download PDF |
| 2.48 | Veterinary Medicines Exemptions guidelines | 2020 | 1 | Guideline | Download PDF |
| 3.14 | Veterinary Clinical Guideline | 2020 | 1 | Guideline | Download PDF |
| GL 1 | Validation of Analytical Procedures: Definition and Terminology | N/A | N/A | Guideline | TBC |
| GL 2 | Validation of Analytical Procedures: Methodology | N/A | N/A | Guideline | TBC |
| GL 3 | Stability Testing of New Veterinary Drug Substances and Medicinal Products | N/A | N/A | Guideline | TBC |
| GL 4 | Stability Testing for New Veterinary Dosage Forms | N/A | N/A | Guideline | TBC |
| GL 5 | Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products | N/A | N/A | Guideline | TBC |
| GL 8 | Stability Testing for Medicated Premixes | N/A | N/A | Guideline | TBC |
| GL 10 | Impurities in New Veterinary Drug Substances | N/A | N/A | Guideline | TBC |
| GL 11 | Impurities in New Veterinary Medicinal Products | N/A | N/A | Guideline | TBC |
| GL 17 | Stability Testing of New Biotechnological / Biological Veterinary Medicinal Products | N/A | N/A | Guideline | TBC |
| GL 18 | Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients | N/A | N/A | Guideline | TBC |
| GL 25 | Testing of Residual Formaldehyde | N/A | N/A | Guideline | TBC |
| GL 26 | Testing of Residual Moisture | N/A | N/A | Guideline | TBC |
| GL 45 | Quality – Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products | N/A | N/A | Guideline | TBC |
| GL 51 | Statistical evaluation of stability data | N/A | N/A | Guideline | TBC |
| Number | File Name | Year Updated | Version | Document Type | Download |
|---|---|---|---|---|---|
| GL 22 | Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing | N/A | N/A | Guideline | TBC |
| GL 23 | Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing | N/A | N/A | Guideline | TBC |
| GL 28 | Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing | N/A | N/A | Guideline | TBC |
| GL 31 | Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: Repeat-Dose (90 Days) Toxicity Testing | N/A | N/A | Guideline | TBC |
| GL 32 | Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing | N/A | N/A | Guideline | TBC |
| GL 33 | Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to Testing | N/A | N/A | Guideline | TBC |
| GL 37 | Guidance for Industry: Studies to Evaluate the Safety of residues of veterinary drugs in human food: Repeat-Dose Chronic toxicity testing | N/A | N/A | Guideline | TBC |
| GL 54 | Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General approach to establish an acute reference dose (ARfD) | N/A | N/A | Guideline | TBC |
| Number | File Name | Year Updated | Version | Document Type | Download |
|---|---|---|---|---|---|
| GL 52 | Blood Level Bioequivalence Study | N/A | N/A | Guideline | TBC |
| Number | File Name | Year Updated | Version | Document Type | Download |
|---|---|---|---|---|---|
| GL 43 | Target Animal Safety – Pharmaceuticals: Target Animal Safety for Veterinary Pharmaceutical Products | N/A | N/A | Guideline | TBC |
| Number | File Name | Year Updated | Version | Document Type | Download |
|---|---|---|---|---|---|
| GL 36 | Studies to Evaluate the Safety of residues of veterinary drugs in human food: General Approach to Establish a Microbiological acceptable daily intake (ADI) | N/A | N/A | Guideline | TBC |
| GL 46 | Studies 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 residues | N/A | N/A | Guideline | TBC |
| GL 47 | Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animals | N/A | N/A | Guideline | TBC |
| GL 48 | Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods | N/A | N/A | Guideline | TBC |
| GL 49 | Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Validation of analytical methods used in residue depletion studies | N/A | N/A | Guideline | TBC |
| GL 56 | Studies 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/A | N/A | Guideline | TBC |
| GL 57 | Studies 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 species | N/A | N/A | Guideline | TBC |