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Register a new trade name product
Application forms and guidance to register a new product or renew registration.
General registration forms and guidelines
- E-files for ACVM applications guideline [PDF, 384 KB]
- Registration of an ACVM trade name product form (ACVM 1) [DOC, 480 KB]
- Vertebrate toxic agent product data sheet guidance [PDF, 423 KB]
- Vertebrate toxic agent product data sheet template (ACVM 1-4) [DOC, 836 KB]
- Vertebrate toxic agent registration information requirements [PDF, 137 KB]
- Labelling vertebrate toxic agents [PDF, 282 KB]
Specific information for registration
Biosecurity
- Biosecurity approval of imported ACVMs guideline [DOCX, 84 KB]
- Biosecurity summary of information provided form [DOCX, 2.2 MB]
Chemistry and manufacturing
- Chemistry of vertebrate toxic agents standard and guideline [PDF, 76 KB]
- Good manufacturing practice (GMP) standard [PDF, 70 KB]
- Good manufacturing practice (GMP) guideline [PDF, 202 KB]
- Standard for vertebrate toxic agents [PDF, 45 KB]
Data assessment
Data protection
- Identification of confidential information for data protection form (ACVM 1DP) [DOCX, 338 KB]
- Protection of confidential information about ACVM trade name products guideline [PDF, 383 KB]
Efficacy
Equivalence and cross-reference
Registration renewal
Get a provisional registration or research approval
Application forms and guidance.
- Provisional registration in New Zealand information requirements [PDF, 91 KB]
- Provisional registration product data sheet template (ACVM 4) [DOC, 492 KB]
- Research approval information requirements [PDF, 91 KB]
- Research approval template (ACVM 5) [DOC, 495 KB]
- Research standard [PDF, 36 KB]
- Operating plans: see below under ‘Non-registration documents’
Vary an existing registration
Forms to vary your registration.
- Variation to registration of ACVM trade name product form (ACVM 1V) [DOC, 436 KB]
- C1 Change formulation form (ACVM 6) [DOC, 643 KB]
- C2 Change or add manufacturer active form (ACVM 7) [DOC, 643 KB]
- C2 Change or add manufacturer formulated product form (ACVM 8) [DOC, 658 KB]
- C2 Change manufacturing (ACVM 9) [DOC, 336 KB]
- C3 Change packaging form (ACVM 10) [DOC, 362 KB]
- C3 Change shelf life form (ACVM 11) [DOC, 344 KB]
- C4/C5 Change crops, species, diseases, conditions form (ACVM 12) [DOC, 706 KB]
- C6/C7 Change dose regime, application rate, timing, method form (ACVM 13) [DOC, 691 KB]
- C8 Change withholding period form (ACVM 14) [DOC, 679 KB]
Non-registration documents
Includes operating plans, class determinations, special circumstances approvals.
Adverse event reporting
Bait devices
- Bait devices definitions [PDF, 317 KB]
Best practice
- VTA registration and best practice tips [PDF, 66 KB]
Class determination and exempt products
- Class determination request form [DOCX, 131 KB]
- Class determination request guideline [DOCX, 99 KB]
- Obligations under the ACVM Regulations guideline [PDF, 418 KB]
- Products regulated under the ACVM Act guideline [PDF, 465 KB]
- Regulation of ACVM products in New Zealand overview [PDF, 322 KB]
Data assessor information and templates
Fees
- Estimated fees for ACVM regulatory assessment of vertebrate toxic agents [DOCX, 52 KB]
- Fees for ACVM regulated and discretionary services [DOCX, 76 KB]
- Revocation of waiver of fees, charges and levies for agricultural compounds and veterinary medicines
Manufacturing, sale, and use
- Advertising registered ACVM products guideline [PDF, 267 KB]
- Approval to import/sell incorrectly labelled ACVM product form (ACVM 16) [DOC, 374 KB]
- Application for Approval to Manufacture Veterinary Medicines and/or Vertebrate Toxic Agents and/or Exempt Products for Export: ACVM 39 [DOCX, 318 KB]
- Application to Vary Approval to Manufacture Veterinary Medicines and/or Vertebrate Toxic Agents and/or Exempt Products for Export: ACVM 71 [DOCX, 126 KB]
- Chemistry of vertebrate toxic agents standard and guideline [PDF, 76 KB]
- Good manufacturing practice (GMP) standard [PDF, 70 KB]
- Good manufacturing practice (GMP) guideline [PDF, 202 KB]
- Labelling vertebrate toxic agents [PDF, 282 KB]
- Separating off portions of registered trade name products policy [PDF, 65 KB]
Notices under the ACVM Act
Operating plans
- Operating plans relevant to the ACVM Act guideline [PDF, 126 KB]
- Operating plan template for RTTOs (ACVM 26) [DOC, 678 KB]
- Operating plan application form for RTTOs (ACVM 26A) [DOCX, 277 KB]
- Operating plans for RTTOs guideline [PDF, 157 KB]
Pindone handler
- Pindone handler application form (ACVM 42) [DOC, 754 KB]
Risk management
- Post-ACVM authorisation risk management overview [PDF, 446 KB]
- Risk management under the ACVM Act overview [PDF, 269 KB]
