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Registration Standards and Guidelines - ACVM

This page contains links to the standards and guidelines for various processes regulated by the ACVM Group. The dates on these links refer to the dates the requirements in these documents become mandatory.

Note 1

New Zealand, together with Australia, participates in the VICH process. New Zealand has implemented finalised VICH guidelines, and as part of its ongoing harmonisation of registration standards with VICH considers both the NZ and VICH standards to be equivalent.

Further details of the VICH Guidelines may be obtained at the following URL: http://www.vichsec.org/en/guidelines2.htm

Note 2

*It should be noted that the GLP requirements in these documents will be mandatory for studies submitted to the ACVM Group after 1 January 2003. Analytical work must be done in an accredited laboratory, and field work must be done in accordance with the ACVM Research standard.

Note 3

*Note change in agricultural security threshold

See also Regulatory Standards

Chemistry

• ACVM Registration Standard and Guideline for the Chemistry of Veterinary Medicines
• ACVM Registration Standard and Guideline for the Chemistry of Plant Compounds
• ACVM Registration Standard and Guideline for the Chemistry of Vertebrate Toxic Agents

*Residue Data

• ACVM Data Requirements for a Food or Feed Use Clearance Plant Compounds (39 pages)
• ACVM Registration Standard and Guideline for Determination of a Residue Withholding Period for Veterinary Medicines (48 pages)

*Research

• ACVM - Research Standard

Target Animal Safety

• ACVM Registration Standard and Guideline for Target Animal Safety

Efficacy

• ACVM - Registration Standard and Guideline for Efficacy of Anthelmintics in Cattle, Sheep, Goats and Deer (9 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Antibloat Products (12 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Anticoccidials in Poultry [mandatory from 1 July 2000] (16 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Antihistamine Products
• ACVM - Registration Standard and Guideline for Efficacy of Antispasmodic Products [mandatory from 10 Jan 2001] (8 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Corticosteroids
• ACVM - Registration Standard and Guideline for Efficacy of Emetics (10 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Intramammary Antimicrobials (10 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Oral Rehydration Therapy (10 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Teat Sanitisers (8 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Vaccines [mandatory from 1 Aug 2001] (21 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Vertebrate Pesticides (17 pages)
• ACVM - Registration Standard and Guideline for Efficacy of Zinc Prophylactic Products for Facial Eczema [mandatory from 1 Dec 2000] (15 pages)

Therapeutic Equivalence of Trade Name Products

• ACVM - Registration Standard and Guideline for Therapeutic Equivalence of Trade Name Products (15 pages)

Hormonal Growth Promotants

• ACVM - Standard for Distributors of Hormonal Growth Promotants (15 pages)

Risk Assessment and Hazard Analysis

• Guidelines for Risk Assessment and Hazard Analysis under the ACVM Act 1997 [mandatory from Nov 2000] (32 pages)

Vertebrate Toxic Agents

• ACVM Standard for Vertebrate Toxic Agents