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, 467 KB]
• Vertebrate toxic agent product data sheet guidance [PDF, 423 KB]
• Vertebrate toxic agent product data sheet template (ACVM 1-4) [DOC, 300 KB]
• Vertebrate toxic agent registration information requirements [PDF, 137 KB]

Specific information for registration

Biosecurity

• Biosecurity approval of imported ACVMs guideline [PDF, 229 KB]
• Biosecurity summary of information provided form [DOC, 1.4 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

• Find assessment report templates on the data assessor web page

Data protection

• Identification of confidential information for data protection form (ACVM 1DP) [DOCX, 369 KB]
• Protection of confidential information about ACVM trade name products guideline [PDF, 505 KB]

Efficacy

• Efficacy of vertebrate pesticides standard and guideline [PDF, 52 KB]

Equivalence and cross-reference

• Deviation from information specified in ACVM registration guidance [PDF, 107 KB]

Registration renewal

• Renewal of registration of ACVM trade name product form (ACVM 1R) [DOC, 463 KB]

• Provisional registration in New Zealand information requirements [PDF, 91 KB]
• Provisional registration product data sheet template (ACVM 4) [DOC, 536 KB]
• Research approval information requirements [PDF, 91 KB]
• Research approval template (ACVM 5) [DOC, 528 KB]
• Research standard [PDF, 36 KB]
• Operating plans: see below under ‘Non-registration documents’

• Variation to registration of ACVM trade name product form (ACVM 1V) [DOC, 471 KB]
• C1 Change formulation form (ACVM 6) [DOC, 536 KB]
• C2 Change or add manufacturer active form (ACVM 7) [DOC, 531 KB]
• C2 Change or add manufacturer formulated product form (ACVM 8) [DOC, 547 KB]
• C2 Change manufacturing (ACVM 9) [DOC, 388 KB]
• C3 Change packaging form (ACVM 10) [DOC, 411 KB]
• C3 Change shelf life form (ACVM 11) [DOC, 394 KB]
• C4/C5 Change crops, species, diseases, conditions form (ACVM 12) [DOC, 542 KB]
• C6/C7 Change dose regime, application rate, timing, method form (ACVM 13) [DOC, 527 KB]
• C8 Change withholding period form (ACVM 14) [DOC, 516 KB]

Adverse event reporting

• Check the adverse events web page 

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 [DOC, 435 KB]
• Class determination request guideline [PDF, 244 KB]
• Obligations under the ACVM Regulations guideline [PDF, 242 KB]
• Products regulated under the ACVM Act guideline [PDF, 428 KB]
• Regulation of ACVM products in New Zealand overview [PDF, 322 KB]

Data assessor information and templates

• Check the data assessors web page

Fees

• Estimated fees for ACVM regulatory assessment of vertebrate toxic agents [PDF, 230 KB]
• Fees for ACVM regulated and discretionary services [PDF, 186 KB]
• Waiver of fees, charges and levies for ACVMs [PDF, 222 KB]

Manufacturing, sale, and use

• Advertising registered ACVM products guideline [PDF, 129 KB]
• Approval to import/sell incorrectly labelled ACVM product form (ACVM 16) [PDF, 203 KB]
• Approval to manufacture veterinary medicines and/or vertebrate toxic agents (ACVM 18) [DOC, 455 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

• Check the ACVM notices page

Operating plans

• Operating plans relevant to the ACVM Act guideline [PDF, 126 KB]
• Operating plan template for RTTOs (ACVM 26) [DOC, 451 KB]
• Operating plan application form for RTTOs (ACVM 26A) [DOC, 429 KB]
• Operating plans for RTTOs guideline [PDF, 157 KB]

Pindone handler

• Pindone handler application form (ACVM 31) [PDF, 475 KB]

Risk management

• Post-ACVM authorisation risk management overview [PDF, 446 KB]
• Risk management under the ACVM Act overview [PDF, 269 KB]

Special circumstances approvals

• Approval to import ACVM product in special circumstances information guideline [PDF, 297 KB]
• Approval to import ACVM product in special circumstances form (ACVM 3) [DOC, 493 KB]