Documents for veterinary medicines

Registration and product data sheet

ACVM 1V Variation to registration of an ACVM trade name product

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ACVM 1R Renewal of registration of an ACVM trade name product

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Veterinary Medicine Product Data Sheet Guidance

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Guidance

Estimated fees for ACVM regulatory assessment of veterinary medicines

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Guidance

Veterinary Medicine Registration in New Zealand ACVM Information Requirements No 1

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Guidance

ACVM 1-2 Registration and product data sheet veterinary medicines

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Veterinary medicines

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ACVM 10 C3: change packaging

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ACVM 11 C3: change shelf life formulated product

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ACVM 12 C4 & C5: change or add target crops species claims diseases conditions

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ACVM 13 C6 & C7 change dose regime application rate or timing change method of administration application

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ACVM 14 C8: change withholding period

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ACVM 16 Approval to import and sell incorrectly labelled Veterinary Medicines, Agricultural Chemicals or Vertebrate Toxic Agents

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ACVM 17 Approval to import and/or distribute Hormonal Growth Promotants (HGPs)

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ACVM 18 Approval to manufacture Veterinary Medicines and/or Vertebrate Toxic Agents

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ACVM 21 Importation of veterinary medicines for use only on accompanied animals

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ACVM 22 Declaration: Imported product not to be sold or used as an agricultural compound

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ACVM 25 Adverse Event Report: Veterinary Medicines

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ACVM 26 Operating Plan Template for Agricultural Compounds Used under the Regulatory Exemption for Research, Testing and Teaching/Training Purposes

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Template

ACVM 27 Operating Plan Template for Sellers of Hormonal Growth Promotants

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Template

ACVM 28 Operating Plan Template for Sellers of Restricted Veterinary Medicines

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Template

ACVM 3 Special Circumstances: Import Approval Request

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ACVM 4 Provisional registration product data sheet of Agricultural Chemical or Veterinary Medicine or Vertebrate Toxic Agent

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ACVM 5 Research approval product data sheet of Agricultural Chemical or Veterinary Medicine or Vertebrate Toxic Agent

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ACVM 6 C1: Change Formulation

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ACVM 7 C2: change or add manufacturer active ingredient

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ACVM 8 C2: change or add manufacturer formulated product

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ACVM 9 C2 change manufacturing

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ACVM Expectations of hormal growth promotant (HGP) sellers with an approved operating plan

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Guidance

ACVM Guideline for Good Manufacturing Practice

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Guidance

ACVM Registration by Reference to APVMA Registration - ACVM Operational Interpretation No 192 August 2010

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR DETERMINATION OF A RESIDUE WITHHOLDING PERIOD FOR VETERINARY MEDICINES

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Standard

ACVM registration standard and guideline for efficacy of antibloat products - standard

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Standard

ACVM REGISTRATION STANDARD AND GUIDELINE FOR EFFICACY OF ANTICOCCIDIALS IN POULTRY

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR EFFICACY OF ANTIHISTAMINE PRODUCTS

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR EFFICACY OF ANTISPASMODIC PRODUCTS

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR EFFICACY OF CORTICOSTEROIDS

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR EFFICACY OF EMETICS

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR EFFICACY OF ORAL REHYDRATION THERAPY

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR EFFICACY OF VACCINES

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR EFFICACY OF ZINC PROPHYLACTIC PRODUCTS FOR FACIAL ECZEMA

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR TARGET ANIMAL SAFETY

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR THE CHEMISTRY OF VETERINARY MEDICINES

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Guidance

ACVM REGISTRATION STANDARD AND GUIDELINE FOR THERAPEUTIC EQUIVALENCE OF TRADE NAME PRODUCTS

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Guidance

Adverse Event Reporting Programme for Veterinary Medicines

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Guidance

Advertising guidelines for products registered under the ACVM Act

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Guidance

Anthelmintics-Efficacy-Cattle-Sheep-Goats-and-Deer

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Guidance

Antimicrobial Agents for Teat Disinfection - Testing efficacy and host safety of a teat disinfectant applied post milking

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Guidance

Changes to ACVM Registration Renewal

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Classification-Veterinary-Describes-Appropriate

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Definitions

Classification-Veterinary-States-Rules

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Guidance

Compounding-Veterinary-Preparation

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Guidance

Data assessment report for Veterinary Medicines - Chemistry and Manufacturing

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Data assessment report for Veterinary Medicines - Efficacy

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Data assessment report for Veterinary Medicines - Overall

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Data assessment report for Veterinary Medicines - Residues

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Data assessment report for Veterinary Medicines - Target Animal Safety

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E-files for ACVM applications

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Requirement

Estimated fees for ACVM regulatory assessment of veterinary medicines

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Guidance

Good Manufacturing Practice (GMP) Certificates - Notification of Name Change Request for New Certificate ACVM 20 (Feb 2017)

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Form

Good Manufacturing Practice (GMP) Certificates - Request for Additional Copies ACVM 19 (July 2015)

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Labelling veterinary medicines

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Requirement

Operating Plans for Restricted Veterinary Medicine Sellers - Guidance

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Requirement - Guidance

Registration-by-reference

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Requirement

Requirements for Authorising Veterinarians

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Guidance

SEPARATING OFF PORTIONS OF REGISTERED TRADE NAME PRODUCTS POLICY 178 ACVM 08/06

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Policy

Special Circumstances Approval ACVM Information Requirements

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Requirement

Veterinary Medicine Product Data Sheet Guidance

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Guidance

Veterinary Medicine Registration in New Zealand ACVM Information Requirements No 1

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Guidance

Veterinary Operating Instructions - Requirements for Authorising Veterinarians Notice

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Guidance
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