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Guidelines

Below is a list of all APVMA guidelines as well as links to key international guidelines. Guidelines published by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products are distinguished with prefix VICH.

The list also includes guidelines for applications to register agricultural and veterinary products. Please see Ag MORAG and Vet MORAG for detailed information on the registration application requirements.

See also: Operational Notices

Guidelines by Title

A B C D E F GHIJKLMNOPQR STUV WXYZ

A

B

Bioequivalence Guidelines for Veterinary Chemical Products - Guideline No. 13

C

D

E

F

G

I

M

Maximum Residue Limit Proposals 'at or about the Limit of Analytical Quantitation' - Residue Guideline No.4

P

R

S

V

W

Withholding Periods - APVMA Residue Guideline No.10

Guidelines by Keyword

A B C D E F G H IJKL MNO PQR S T U V WXYZ

A

Abalone - Residues in Abolone - Residue Guideline No.29
Allergenic substances - Guidelines for Registration of Allergenic Substances - Guideline No.31
Analytical methods - Validation of Analytical Methods for Active Constituent, Agricultural and Veterinary Chemical products - Guideline No.69 (PDF, 164kb)
Analytical methods - Residue Analytical Method Residue Guideline No.19
Analytical methods (veterinary drug) - Veterinary Drug Residue Analytical Methods - Residue Guideline No.26
Analytical quantitation - Maximum Residue Limit Proposals 'at or about the Limit of Analytical Quantitation' - Residue Guideline No.4
Animal Housing - Residue Guideline No.13
Animal tissue trials - Data Requirements for Animal Tissue Residue Trials - Residue Guideline No.23
Animal Transfer Studies - Residue Guideline No.1
Antifouling Efficacy Data Guidelines
Anthelmintics - Canine VICH GL19 (external site)
Anthelmintics - Efficacy Standards for Ruminant Anthelmintics in Australia (PDF, 11kb)
Anthelmintics - Bovines VICH GL12 (external site)
Anthelmintics - Canine VICH GL19 (external site)
Anthelmintics - Caprine VICH GL14 (external site)
Anthelmintics - Equine VICH GL15 (external site)
Anthelmintics - Feline VICH GL20 (external site)
Anthelmintics - General VICH GL7 (external site)
Anthelmintics - Ovine VICH GL13 (external site)
Anthelmintics - Poultry VICH GL21 (external site)
Anthelmintics - Swine VICH GL16 (external site)

B

C

Combination products - Veterinary Combination Products - Residue Guideline No.9
Canine anthelmintics - VICH GL19 (external site)
Carcinogenicity - VICH GL28 (external site)
Cattle - External Treatment of Cattle with Ectoparasiticides - Residue Guideline No.3
Cattle tick - Guideline for the Establishment of Efficacy and Management Data in Support of Applications for the Registration of Products to be Used in Control of the Cattle Tick (Boophilus Microplus) - Guideline No.20
Clinical practices (GCP) VICH GL9
Coccidiostats - Guideline for Evaluation of the Efficacy and Safety of Coccidiostats - Guideline No.24
Crop to animal transfer - Animal Transfer Studies - Residue Guideline No.1
Crops - Failed Crops - Residue Guideline No.2
Crops - Post-Harvest Applications Except Fumigants and Grain Protectants - Residue Guideline No.14

D

E

Ectoparasiticide Residues in Sheep Tissues - Residue Guideline No.27
Ectoparasiticides - Guidelines for Acceptable Claims Based on Currently Approved Active Constituents for Ectoparasiticides Used on Cats, Dogs or Ornamental Caged Birds - Guideline No.16 (PDF, 83kb)
Ectoparasiticides - Guideline for Establishment of Efficacy and Management Data in support of Applications for the Registration of Products to be used in Control of the Buffalo Fly (Haematobia Irritans Exigua) - Guideline No.19 (PDF, 45kb)
Ectoparasiticides - Guideline for the Establishment of Efficacy and Management Data in Support of Applications for the Registration of Products to be Used in Control of the Cattle Tick (Boophilus Microplus) - Guideline No.20
Ectoparasiticides - External Treatment of Cattle with Ectoparasiticides - Residue Guideline No.3
Ectoparasiticides - Guidelines for Ovine Lousicides Efficacy Submissions - Guideline No.23
Ectoparasiticides - Guidelines for Ovine Miticides Efficacy Submissions - Guideline No.22
Ectoparasiticides - Guidelines for the Registration of Agents for the Control and Treatment of Non-benign Ovine Footrot - Guideline No.18
Ectoparasiticides - Guidelines for Small Animal Ectoparasiticide Efficiacy Submission - Guideline No.17
Ecotoxicity - Phase 1 VICH GL6 (external site)
Ecotoxicity - Phase II VICH GL38 (external site)
Equine electrolyte products - Oral electrolyte products for the treatment of horses in exercise
Extension of Shelf-life - Requirements and Guidelines for a Particular Batch Shelf Life Extension Permit for a Registered Veterinary Chemical Product - Guideline No.48 (PDF, 65kb)
Extrapolation of Data - Isomers - Residue Guideline No.20

F

Failed Crops - Residue Guideline No.2
Feeds/Supplements - Guidelines for the Registration of Direct Fed Microbial Products - Guideline No.9
Feeds/Supplements - Guidelines for the Registration of Enzyme Based Products used in Stock Feeds - Guideline No.10 (PDF, 136kb)
Feeds/Supplements - Guidelines for Stock Foods and Stock Food Additives - Guideline No.7
Feeds/Supplements - Guideline for Stockfeed Supplement Products Containing Vitamins, Minerals or Amino Acids and Containing Only ‘Nutritional Messages’ - Guideline No.8 (PDF, 82kb)
Feeds/Supplements - Guidelines for Therapeutic Pet Foods that Require Registration by the APVMA as Veterinary Chemical Products’ - Guideline No.11 (PDF, 471kb)
Flystrike - Guideline for Blowfly Specific (Flystrike Preventatives and Treatments) Efficacy Submissions - Guideline No.21
Formulation Changes - Animal Health - Residue Guideline No.18
Fumigants - Residue Guideline No.15

G

H

Honey - Residues in Honey - Residue Guideline No. 28
Herbal Remedies - Requirements and Guidelines for Veterinary Herbal Remedies Guideline No.70
Herbicides - Guidelines for Efficacy Evaluation of Herbicides - Weeds in Australian Forests (PDF, 246kb)

I

Immunobiological Products - Data Requirements and Guidelines for Registration of New Veterinary Immunobiological Products - Guideline No.47 (PDF, 257kb)
Immunobiological Products - Data Requirements and Guidelines for Variations to Immunobiological Products - Guideline No.49 (PDF, 141kb)
Impurities - New Substances VICH GL10 (external site)
Impurities - New Veterinary Medicinal Products (VMPs) VICH GL11 (external site)
Impurities - Residual Solvents VICH GL18 (external site)
Injectable products - Injectable Veterinary Products - Residue Guideline No.16
Intramammaries - Guidelines for Registration of Intramammary Preparations for Treatment of Bovine Mastitis - Guideline No.25
Isomer forms - Extrapolation of Data - Isomers - Residue Guideline No.20

L

LAL test - Policy on Limulus Amebocyte Lysate (LAL) Test - Guideline No.32 (PDF, 55kb)
Limit of analytical quantitation - Maximum Residue Limit Proposals 'at or about the Limit of Analytical Quantitation' - Residue Guideline No.4
Limulus Amebocyte Lysate - Policy on Limulus Amebocyte Lysate (LAL) Test - Guideline No.32 (PDF, 55kb)

M

Maximum residue limits - Residue Trials to Obtain Permanent MRLS for Crops - Residue Guideline No.24
Metabolic diseases, treatment of sheep and cattle - Draft Policy on Calcium, Magnesium, Glucose and Phosphorus Solutions for the Treatment of Metabolic Diseases in Sheep and Cattle - Guideline No.40
Milk - Residues in Milk - Parasiticides and Drugs other than Antimicrobials - Residue Guideline No.22

O

Ovine footrot - Guidelines for the Registration of Agents for the Control and Treatment of Non-benign Ovine Footrot - Guideline No.18
Ovine lousicides - Guidelines for Ovine Lousicides Efficacy Submissions - Guideline No.23
Ovine miticides - Guidelines for Ovine Miticides Efficacy Submissions - Guideline No.22

P

Paraciticides - External Treatment of Cattle with Ectoparasiticides - Residue Guideline No.3
Pastures - Residue Guideline No.5
Pet foods - Guidelines for Therapeutic Pet Foods that Require Registration by the APVMA as Veterinary Chemical Products’ - Guideline No.11 (PDF, 471kb)
Pool sanitisers - Demonstrating efficacy of pool and spa sanitisers (PDF, 124kb)
Post harvest treatments - Registration of Post Harvest Treatments - Registration of Post Harvest Treatments (PDF, 333kb)
Post harvest application - Crops - Post-Harvest Applications Except Fumigants and Grain Protectants - Residue Guideline No.14
Poultry tissues and eggs - Residues in Poultry Tissues and Eggs - Residue Guideline No.31 (PDF, 34kb)
Processing Studies - Residue Guideline No.7
Pro-pesticides or Drugs - Residue Guideline No.12

R

S

Safety - Carcinogenicity VICH GL28 (external site)
Safety - Developmental Toxicity VICH GL32 (external site)
Safety - General Approach VICH GL33 (external site)
Safety - Genotoxicity VICH GL23 (external site)
Safety - Repeat-dose Toxicity VICH GL31 (external site)
Safety - Reproduction VICH GL22 (external site)
Sheep and cattle - Draft Policy on Calcium, Magnesium, Glucose and Phosphorus Solutions for the Treatment of Metabolic Diseases in Sheep and Cattle - Guideline No.40
Sheep branding substances - Policy for Registration of Sheep Branding Substances - Guideline No.42 (PDF, 37kb)
Sheep tissue - Ectoparasiticide Residues in Sheep Tissues - Residue Guideline No.27
Shelf-life - Requirements and Guidelines for a Particular Batch Shelf Life Extension Permit for a Registered Veterinary Chemical Product - Guideline No.48 (PDF, 65kb)
Spa sanitisers - Demonstrating efficacy of pool and spa sanitisers (PDF, 124kb)
Stockfeed Guidelines 1. Primary Feed Commodities as a Proportion of Livestock Diets (PDF, 32kb)
Stockfeed Guidelines 2. Setting Animal Commodity MRLs Based on Livestock Dietary Exposure (PDF, 28kb)
Stock Feed - Guidelines for the Registration of Enzyme Based Products used in Stock Feeds - Guideline No.10 (PDF, 136kb)
Stock Feed - Guidelines for Stock Foods and Stock Food Additives - Guideline No.7
Stock Feed - Guideline for Stockfeed Supplement Products Containing Vitamins, Minerals or Amino Acids and Containing Only ‘Nutritional Messages’ - Guideline No.8 (PDF, 82kb)
Stability of residues during storage - Chemicals and Products - Residue Guideline No.8
Storage stability data - Generation of Storage Stability Data of Agricultural Chemical Products - PDF, 333kb)
Storage stability data - Generation of Storage Stability Data of Veterinary Chemical Products - Guideline No.68 (PDF, 197kb)

T

Teat sanitisers - Interim guidelines for Data to Support Efficacy and Safety of Teat Sanitisers - Guideline No.46 (PDF, 34kb)
Tissue trials - Data Requirements for Animal Tissue Residue Trials - Residue Guideline No.23
Toxicity - VICH GL32 (external site)

V

Validating analytical methods - Validation of Analytical Methods for Active Constituent, Agricultural and Veterinary Chemical Products - APVMA Guideline No.69 (PDF, 164kb)
Veterinary chemical products - Bioequivalence Guidelines for Veterinary Chemical Products - APVMA Guideline No.13
Veterinary Drug Residue Analytical Methods - Residue Guideline No.26

W

Withholding Periods - APVMA Residue Guideline No.10

Guidelines by Type and Number

Guidelines Residue Guidelines Other APVMA Guidelines VICH Guidelines

Numbered Guidelines

Guideline No.7 - Guidelines for Stock Foods and Stock Food Additives - Guideline No.7
Guideline No.8 - Guideline for Stockfeed Supplement Products Containing Vitamins, Minerals or Amino Acids and Containing Only ‘Nutritional Messages’ - Guideline No.8 (PDF, 82kb)
Guideline No.9 - Guidelines for the Registration of Direct Fed Microbial Products - Guideline No.9
Guideline No.10 - Guidelines for the Registration of Enzyme Based Products used in Stock Feeds - Guideline No.10 (PDF, 136kb)
Guideline No.11 - Guidelines for Therapeutic Pet Foods that Require Registration by the APVMA as Veterinary Chemical Products’ - Guideline No.11 (PDF, 471kb)
Guideline No.13 - Bioequivalence Guidelines for Veterinary Chemical Products - Guideline No.13
Guideline No.16 - Guidelines for Acceptable Claims Based on Currently Approved Active Constituents for Ectoparasiticides Used on Cats, Dogs or Ornamental Caged Birds - Guideline No.16 (PDF, 83kb)
Guideline No.17 - Guidelines for Small Animal Ectoparasiticide Efficiacy Submission - Guideline No.17
Guideline No.18 - Guidelines for the Registration of Agents for the Control and Treatment of Non-benign Ovine Footrot - Guideline No.18
Guideline No.19 - Guideline for Establishment of Efficacy and Management Data in support of Applications for the Registration of Products to be used in Control of the Buffalo Fly (Haematobia Irritans Exigua) - Guideline No.19 (PDF, 45kb)
Guideline No.20 - Guideline for the Establishment of Efficacy and Management Data in Support of Applications for the Registration of Products to be Used in Control of the Cattle Tick (Boophilus Microplus) - Guideline No.20
Guideline No.21 - Guideline for Blowfly Specific (Flystrike Preventatives and Treatments) Efficacy Submissions - Guideline No.21
Guideline No.22 - Guidelines for Ovine Miticides Efficacy Submissions - Guideline No.22
Guideline No.23 - Guidelines for Ovine Lousicides Efficacy Submissions - Guideline No.23
Guideline No.24 - Guideline for Evaluation of the Efficacy and Safety of Coccidiostats - Guideline No.24
Guideline No.25 - Guidelines for Registration of Intramammary Preparations for Treatment of Bovine Mastitis - Guideline No.25
Guideline No.31 - Guidelines for Registration of Allergenic Substances - Guideline No.31
Guideline No.32 - Policy on Limulus Amebocyte Lysate (LAL) Test - Guideline No.32 (PDF, 55kb)
Guideline No.40 - Draft Policy on Calcium, Magnesium, Glucose and Phosphorus Solutions for the Treatment of Metabolic Diseases in Sheep and Cattle - Guideline No.40
Guideline No.42 - Policy for Registration of Sheep Branding Substances - Guideline No.42 (PDF, 37kb)
Guideline No.46 - Interim guidelines for Data to Support Efficacy and Safety of Teat Sanitisers - Guideline No.46 (PDF, 34kb)
Guideline No.47 - Data Requirements and Guidelines for Registration of New Veterinary Immunobiological Products - Guideline No.47 (PDF, 257kb)
Guideline No.48 - Requirements and Guidelines for a Particular Batch Shelf Life Extension Permit for a Registered Veterinary Chemical Product - Guideline No.48 (PDF, 65kb)
Guideline No.49 - Data Requirements and Guidelines for Variations to Immunobiological Products - Guideline No.49 (PDF, 141kb)
Guideline No.68 - Guidelines for the Generation of Storage Stability Data of Veterinary Chemical Products - Guideline No. 68 (PDF, 197kb)
Guideline No.69 - Validation of Analytical Methods for Active Constituent, Agricultural and Veterinary Chemical Products - Guideline No.69 (PDF, 164kb)
Guideline No.70 - Requirements and Guidelines for Veterinary Herbal Remedies
Guideline No.71 - Oral electrolyte products for the treatment of horses in exercise

Residue Guidelines

Residue Guideline No.1 - Animal Transfer Studies - Residue Guideline No.1
Residue Guideline No.2 - Failed Crops - Residue Guideline No.2
Residue Guideline No.3 - External Treatment of Cattle with Ectoparasiticides - Residue Guideline No.3
Residue Guideline No.4 - Maximum Residue Limit Proposals 'at or about the Limit of Analytical Quantitation' - Residue Guideline No.4
Residue Guideline No.5 - Pastures - Residue Guideline No.5
Residue Guideline No.6 - Definition of Residues for Purpose of Setting an MRL - Residue Guideline No.6
Residue Guideline No.7 - Processing Studies - Residue Guideline No.7
Residue Guideline No.8 - Residue Guideline No.8 - Chemicals and Products
Residue Guideline No.9 - Veterinary Combination Products - Residue Guideline No.9
Residue Guideline No.10 - Withholding Periods - APVMA Residue Guideline No.10
Residue Guideline No.11 - Reporting of Residue Trials - Residue Guideline No.11
Residue Guideline No.12 - Pro-pesticides or Drugs - Residue Guideline No.12
Residue Guideline No.13 - Animal Housing - Residue Guideline No.13
Residue Guideline No.14 - Crops - Post-Harvest Applications Except Fumigants and Grain Protectants - Residue Guideline No.14
Residue Guideline No.15 - Fumigants - Residue Guideline No.15
Residue Guideline No.16 - Injectable Veterinary Products - Residue Guideline No.16
Residue Guideline No.17 - Rodenticides - Residue Guideline No.17
Residue Guideline No.18 - Animal Health - Residue Guideline No.18
Residue Guideline No.19 - Residue Analytical Method Residue Guideline No.19
Residue Guideline No.20 - Extrapolation of Data - Isomers - Residue Guideline No.20
Residue Guideline No.21 - Grapes - Residue Guideline No.21
Residue Guideline No.22 - Residues in Milk - Parasiticides and Drugs other than Antimicrobials - Residue Guideline No.22
Residue Guideline No.23 - Data Requirements for Animal Tissue Residue Trials - Residue Guideline No.23
Residue Guideline No.24 - Residue Trials to Obtain Permanent MRLS for Crops - Residue Guideline No.24
Residue Guideline No.25 - Residues in Milk – Antimicrobials - Residue Guideline No.25
Residue Guideline No.26 - Veterinary Drug Residue Analytical Methods - Residue Guideline No.26
Residue Guideline No.27 - Ectoparasiticide Residues in Sheep Tissues - Residue Guideline No.27
Residue Guideline No.28 - Residues in Honey - Residue Guideline No.28
Residue Guideline No.29 - Residues in Abolone - Residue Guideline No.29
Residue Guideline No.30 - Assessment of the Effect of Antimicrobial Substances on Activity of Dairy Starter Cultures - Residue Guideline No.30
Residue Guideline No.31 - Residues in Poultry Tissues and Eggs - Residue Guideline No.31 (PDF, 34kb)

Other APVMA Guidelines

VICH Guidelines

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