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Veterinary Guidelines
| General | Chemistry | Residues | Bioequivalence | VICH |
| Ectoparasiticides | Anthelmintics | Feeds/Supplements | Intramammaries | Immunobiologicals |
Two new VICH guidelines released for comment A program aimed at harmonising technical requirements for veterinary product registration was officially launched in Paris in April 1996, as a cooperative effort between members of the regulatory authorities and the veterinary chemical industry from the European Union, U.S.A., and Japan. The program is the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (also known as VICH), which has drawn on the experience of the human pharmaceutical harmonisation initiative, ICH. The regulatory authorities of Australia and New Zealand have observer status on the VICH Steering Committee. VICH GL36 - Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI The APVMA proposes to adopt these guidelines after a period of public comment. Draft guidelines for immunobiological products. |
Registration
1. - 6. These guidelines are published as Fact Sheets and Information sheets on a range of topics including fees and levies, registration of agvet products, permits etc.
Stock Feeds/Vitamin and Mineral Supplements/Feed Enzymes/Direct Fed Microbials/Therapeutic Pet Food Diets
7. Policy on Stock Feeds and Stock Feed Additives
8. Guideline for Stockfeed Supplement Products Containing Vitamins, Minerals or Amino acids and Containing only 'Nutritional Messages' (
PDF - 84KB)
9. Guidelines for the Registration of Direct Fed Microbial Products used in Stock Feeds
10.
Guidelines for the Registration of Enzyme Based Products ( PDF - 136KB)
11. Therapeutic Pet Food Diets June 2005
Bioequivalence/Bioavailability Guidelines
13. Policy on the Requirement to Demonstrate Bioequivalence and Bioavailability April 2000
Companion Animal Ectoparasiticide Guidelines
16.
Guidelines for acceptable claims based on currently approved constituents
for ectoparasiticides ( PDF - 84KB) used
on cats, dogs or ornamental caged birds - May 1996
17. Guidelines for small animal ectoparasiticide efficacy submission - 24 July 1996
Food Producing Animal Ectoparasiticide Guidelines
18. Guidelines for the registration of agents for the control and treatment of non-benign ovine footrot - May 1996
19.
Guidelines for the 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) - May 1996 ( PDF - 48KB)
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) - May 1996
21. Guideline for blowfly specific (Flystrike preventatives and treatments) efficacy submissions - May 1996
22. Guidelines for ovine miticides efficacy submissions May 1996
23. Guidelines for ovine lousicides efficacy submissions - May 1996
Intramammaries
25. Guidelines for registration of intrammammary preparations for treatment of Bovine Mastitis
Anthelmintics
26. Guidelines for the Registration of Combination Anthelmintics
27. WAAVP guidelines for evaluating the Efficacy of Anthelmintics in Dogs and Cats (available by telephoning Vet Contact Officer on (02) 6210 4726)
28. WAAVP guidelines for evaluating the Efficacy of Anthelmintics in Equines (available by telephoning Vet Contact Officer on (02) 6210 4726)
29. WAAVP guidelines for evaluating the Efficacy of Anthelmintics in Ruminants (available by telephoning Vet Contact Officer on (02) 6210 4726)
30. WAAVP Guidelines for evaluating the Efficacy of Anthelmintics in Swine (available by telephoning Vet Contact Officer on (02) 6210 4726)
Immunobiologicals
47. Data requirements and guidelines for applications to register new veterinary immunobiological products ( PDF - 144KB) May 2006
49. Guidelines for variations to immunobiological products May 2006 ( PDF - 40KB)
General Guidelines
24. Guidelines for the Efficacy and Safety of Coccidiostats
31. Registration requirements for Allergenic Substances
32.
Policy on Limulus Amebocyte Lysate (LAL) Test ( PDF - 56KB)
40. Policy Document on Calcium, Magnesium, Glucose and Phosphorus Solutions for the Treatment of Metabolic Diseases in Sheep and Cattle
42.
Policy for the registration of Sheep Branding Substances ( PDF - 40KB)
46.
Guidelines for data to support efficacy and safety of teat
sanitisers - June 2002 ( PDF - 28KB)
Chemistry
68. Guidelines for the generation of storage stability data for veterinary chemical products June 2006 ( PDF - 200KB)
69. Guidelines for the validation of analytical methods October 2004 ( PDF - 164KB)
48. APVMA Requirements for the application / assessment / approval of extension of shelf-life ( PDF - 20KB) for a particular batch of a registered veterinary chemical product. June 2002
Residues
VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products)
51. VICH Guidelines for Efficacy of Anthelmintics - General Requirements Release Date 5 June 2001
52. VICH Guidelines for Efficacy of Anthelmintics - Specific Recommendations for Bovines Release Date 5 June 2001
53.VICH Guidelines for Efficacy of Anthelmintics - specific recommendations for ovines Release Date 5 June 2001
54.VICH Guidelines for Efficacy of Anthelmintics - specific recommendations for caprines
55. VICH Guidelines for Impurities in New Veterinary Drug Substances Release Date 1 May 2001
56. VICH Guidelines for Impurities in New Veterinary Chemical Products Release Date 1 May 2001
57. VICH Guidelines for Environment Impact Assessment for Veterinary Medicinal Products (VMPS) Amended 7 December 2004. The APVMA Guideline comprises two VICH Guidelines : Environmental impact assessment for veterinary medicinal products Phase I, GL6 and Environmental impact assessment for veterinary medicinal products Phase II, GL38.
58. VICH Guidelines for Good Clinical Practices Release Date 3 July 2001
59. VICH Guidelines for Stability Testing of Biotechnological/Biological Veterinary Medicinal Products Release Date 3 July 2001
60. VICH Guidelines for Impurities - residual solvents Release date 7 August 20001
61.VICH Efficacy of Anthelmintics: specific recommentations for equine Release date 2 July 2002
62.VICH Efficacy of Anthelmintics: specific recommentations for porcines Release date 2 July 2002
63.VICH Efficacy of Anthelmintics: specific recommentations for canines Release date 2 July 2002
64.VICH Efficacy of Anthelmintics: specific recommentations for felines Release date 2 July 2002
65.VICH Efficacy of Anthelmintics: specific recommentations for poultry Release date 2 July 2002
66. Studies to evaluate the safety of residues of veterinary drugs in human food: reproduction testing. The APVMA guidelines consists of VICH Guidelines no 22 and NRA Gazette no. NRA 8, 6 August 22 page 51. August 2002
67. Studies to evaluate the safety or residues of veterinary drugs in human food: genotoxicity testing. The APVMA guideline consists of VICH Guideline no. 23 dated June 2001 and the NRA Gazette no. NRA 8, 6 August 22 page 51
70 Safety of residues
of veterinary drugs in human food - Carcinogenicity studies
The APVMA guideline consists of VICH
Guideline no. 28 dated October 2002 and the APVMA
Gazette no. APVMA 10, 7 October 2003 pages 68-69.
71 Safety of residues of veterinary drugs in human food - Repeat-dose
(90 days) toxicity testing
The APVMA guideline consists of VICH
Guideline no. 31 dated October 2002 and the APVMA
Gazette no. APVMA 10, 7 October 2003 pages 68-69.
72 Safety of residues of veterinary drugs in human food - developmental
toxicity testing
The APVMA guideline consists of VICH
Guideline no. 32 dated October 2002 and the APVMA
Gazette no. APVMA 10, 7 October 2003 pages 68-69.
73 Safety of residues of veterinary drugs in human food - General approach
to testing.
The APVMA guideline consists of VICH
Guideline no. 33 dated October 2002 and the APVMA
Gazette no. APVMA 10, 7 October 2003 pages 68-69.