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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 by reference to APVMA registration guideline [PDF, 63 KB]
- Registration of an ACVM trade name product form (ACVM 1) [DOC, 480 KB]
- Veterinary medicine product data sheet guidance [PDF, 457 KB]
- Veterinary medicine product data sheet template (ACVM 1-2) [DOC, 351 KB]
- Veterinary medicine registration information requirements [PDF, 127 KB]
- Labelling veterinary medicines [PDF, 217 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 and manufacture of veterinary medicines (chemical) [PDF, 965 KB]
- Good manufacturing practice (GMP) standard [PDF, 70 KB]
- Good manufacturing practice (GMP) guideline [PDF, 202 KB]
- Labelling veterinary medicines [PDF, 217 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
- Anthelmintics in cattle, sheep, goats and deer [PDF, 535 KB]
- Antibloat products [PDF, 38 KB]
- Anticoccidials in poultry [PDF, 41 KB]
- Antihistamine products [PDF, 238 KB]
- Antimicrobial agents for teat disinfection [PDF, 238 KB]
- Antispasmodic products [PDF, 27 KB]
- Corticosteroids [PDF, 42 KB]
- Emetics [PDF, 33 KB]
- Methane Inhibitor product [PDF, 366 KB]
- Oral rehydration therapy products [PDF, 33 KB]
- Vaccines [PDF, 37 KB]
- Zinc prophylactic products for facial eczema [PDF, 41 KB]
Equivalence and cross-reference
- Deviation from information specified in ACVM registration guidance [DOCX, 799 KB]
- Equivalence of veterinary medicine trade name products [PDF, 433 KB]
Residues
- Determination of residue withholding period for veterinary medicines [PDF, 148 KB]
- Maximum residue levels (MRLs)
Target animal safety
- Target animal safety standard and guideline [PDF, 54 KB]
Registration renewal
Get a Veterinary Medicine Trial Approval
Application forms and guidance.
- ACVM Guidance: Veterinary Medicine Trial Approvals [PDF, 462 KB]
- Veterinary Medicine Trial Approval Data Sheet (ACVM 81) [DOCX, 146 KB]
- Research standard [PDF, 36 KB]
Vary an existing registration
Forms to vary your registration.
- Application to Vary the Registration of a Veterinary Medicine Trade Name Product (ACVM 1V-VM) [DOCX, 121 KB]
- Application to Vary the Chemistry and or Manufacturing Information for a Veterinary Medicine Trade Name Product (ACVM 79) [DOCX, 141 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.
ACVM export certificate
Certificate of compliance request form ACVM 78 (July 2024) [DOCX, 69 KB]
Adverse event reporting
Antimicrobial resistance
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]
- Inclusion of a Registered Veterinary Medicine in an Oral Nutritional Compound Exempt from the Requirement for Registration [PDF, 214 KB]
Data assessor information and templates
Fees
- Estimated fees for ACVM regulatory assessment of veterinary medicines [DOCX, 82 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
Import declaration forms
- Declaration imported product not to be sold or used as an agricultural compound form (ACVM 22) [DOCX, 74 KB]
- Declaration importation of veterinary medicine only to be used on accompanied animal form (ACVM 21) [DOCX, 296 KB]
Manufacturing, sale, and use
- ACVM expectations of HGP sellers with an approved operating plan [PDF, 157 KB]
- Advertising registered ACVM products guideline [PDF, 267 KB]
- Approval to import/sell incorrectly labelled ACVM product form (ACVM 16) [DOC, 374 KB]
- Approval to import/distribute hormonal growth promotants form (ACVM 17) [DOCX, 604 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]
- Developing a documented system for compounding veterinary preparations guideline [PDF, 209 KB]
- Good manufacturing practice (GMP) standard [PDF, 70 KB]
- Good manufacturing practice (GMP) guideline [PDF, 202 KB]
- Good manufacturing practice (GMP) certificate (additional copies) form (ACVM 30) [DOCX, 995 KB]
- Labelling veterinary medicines [PDF, 217 KB]
- Separating off portions of registered trade name products policy [PDF, 65 KB]
Maximum residue levels (MRLs)
Notices under the ACVM Act
Operating plans
- ACVM expectations of HGP sellers with an approved operating plan [PDF, 157 KB]
- 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]
- Operating plan template for HGP sellers (ACVM 32) [DOC, 405 KB]
- Operating plan template for RVM sellers (ACVM 33) [DOC, 524 KB]
- Operating plans for RVM sellers guideline [PDF, 180 KB]
Risk management
- Classification of veterinary medicines policy [PDF, 75 KB]
- Classification of veterinary medicines in regard to sale, purchase and use policy [PDF, 81 KB]
- 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, 770 KB]
Veterinarians
- Requirements for authorising veterinarians [PDF, 223 KB]
- Veterinary operating instructions [PDF, 231 KB]
