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Specific guidelines

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  • Search products and permits
    • Search PubCRIS (Opens in a new tab/window)
    • Using PubCRIS
  • Chemical product registration
    • Applying for approvals, registrations and variations
    • Applying for a label approval
    • Which products/chemicals require registration
      • Does my veterinary product need to be registered?
        • User guide: what is or isn't a veterinary product?
          • Animal cosmetic products
            • Excluded animal cosmetic products – acceptable cosmetic messages
          • Animal feed products
            • Acceptable nutritional messages
            • Feed supplements – acceptable nutritional messages
            • Other requirements for whole unprocessed animal tissue
          • Devices, equipment and physical barrier products
          • Other products that don't require registration
        • Registration self-assessment tool (veterinary)
      • Does my agricultural product need to be registered?
      • Stockfeed and petfood regulation
        • END product FAQs
      • Novel products
      • Arrangements for products of low regulatory concern
        • Registration models
          • Oral electrolyte products for the treatment of horses in exercise
        • Reserved chemical products
        • Listed chemical product
      • Substances not permitted for use on food-producing animals in Australia
      • Lures and attractants
    • Before you apply
      • About the approval and registration process
      • Who can apply
      • Restricted chemical products
      • Conditions of approval or registration and label approval
      • Minor variations
      • The risk analysis process
      • Timeframes and fees
      • Interchangeable Constituent Determination – Item 29
    • What to include in your application
      • Data guidelines
      • Guidance for preparing information lists
      • Dossiers
      • Required information
      • Statutory criteria
        • Active constituent
        • Chemical product
        • Satisfying the statutory criteria
      • Providing evidence of GMP
      • Guidance for applicants – submission of international data, standards and assessments
        • Accepted international data and standards
        • International and other national assessments
        • How to submit an international assessment
        • What happens once I submit my overseas/international assessment?
    • Guide to completing an online application
      • Online Services Portal
      • Decision tree
      • Identification, applicant and nominated agent details
      • Data and information lists
        • Using the information list editor
      • Access to information
      • Formulation
      • Manufacturing
      • Packaging and storage
      • Labels
      • Submitting an application
      • Submitting third party information
    • After you apply
      • Preliminary assessment process
        • Preliminary assessment guideline
      • Altering applications
      • Requiring additional information
      • Requiring samples to be given for analysis
      • Extended assessment period and maximum response period
      • Requesting information from applicants
    • Primary and secondary applications
    • Renew a registration
    • Technical policy
    • After registration
      • Annual returns
        • Annual returns – FAQs
      • Changes to products and actives
        • Holders to notify the APVMA of new information
      • Levies charged on chemical products
        • Declaration of leviable values
        • Notice of levy calculation
    • APVMA Permit-to-label project
      • Permit-to-label project background
  • Applying for permits
    • Before you apply
      • About the application process
      • Types of permits
        • Export, research and miscellaneous permits
        • Minor use and emergency permits
          • Guide for determining emergency uses or research purposes
          • Guide for determining minor uses
      • Who can apply
      • Timeframes and fees
      • Ability to comply with conditions
    • What to include in your application
      • Required information
      • Statutory criteria
      • Labelling requirements
    • After you apply
      • What happens next
      • Requiring samples or further information
    • Extend the duration of a permit
    • Search for a permit
  • Data guidelines
    • Agricultural data guidelines
      • Adopted international technical guidance material
      • Chemistry and manufacture (Part 2)
        • Generation of storage stability data for agricultural chemical products
      • Toxicology (Part 3)
      • Metabolism and kinetics (Part 4)
      • Residues (Part 5A)
        • Specific guidelines
      • Overseas trade (Part 5B)
      • Occupational health and safety (Part 6)
      • Environment (Part 7)
        • Roadmap for insect pollinator risk assessments in Australia
      • Pesticides efficacy and crop safety general guideline (Part 8)
        • Specific guidelines
      • Special data (Part 10) - Products of gene technology
      • Special data (Part 10) – Products of nanotechnology
      • Guideline for the regulation of biological agricultural products
      • Guidance on assessment and registration of anti-fouling paints
      • Relevant data for module levels – agricultural chemical products
    • Veterinary data guidelines
      • Adopted international technical guidance material
      • Chemistry and manufacture (Part 2)
        • Chemistry and manufacture of active constituents (Part 2)
          • Approval of active constituents for which information is not readily available
        • Chemistry and manufacture of products (Part 2)
        • Additional data guidelines for chemistry and manufacture (Part 2)
      • Toxicology (Part 3)
      • Metabolism and kinetics (Part 4)
        • Comparative metabolism studies, selection of marker residues and ratios of marker residues to total residues
      • Residues (Part 5A)
        • Specific guidelines
      • Overseas trade (Part 5B)
        • Veterinary drug residues in food commodities and overseas trade
      • Occupational health and safety (Part 6)
      • Environment (Part 7)
      • Efficacy and target animal safety general guideline (Part 8)
      • Special data (Part 10)
      • Specific guidelines
      • Relevant data for module levels – veterinary chemical products
      • Guidelines for data to support efficacy and safety of teat disinfectants
    • Crop Groups
      • What is crop grouping?
      • Crop groupings project – consolidated responses to phase one consultation
        • NWPGP grain industry comments
    • Module descriptors
    • Risk assessment manuals
  • Labelling Codes
    • Agricultural Labelling Code
    • Veterinary Labelling Code
      • Specific labelling requirements
        • Anthelmintics for dogs and cats
        • Anthelmintics for horses
        • Anthelmintics for sheep, goats and cattle
        • Anti-inflammatories
        • Antibiotics
        • Complementary animal health products
        • Ectoparasiticides for dogs and cats
        • Ectoparasiticides for sheep and goats
        • Euthanasiates
        • Hormonal growth promotants
        • Immunobiological products (veterinary vaccines, antisera, biologicals)
        • Intramammary preparations
        • Intraruminal products
        • Non-prescription injectable products
        • Products containing minerals
        • Products for application to wounds
        • Professional packs of oral non-prescription products
        • Stomach tubing products
        • Teat dips and sprays
        • Therapeutic pet food products
      • Preparing a label and approval process
      • Label content
        • General labelling requirements
        • Anthelmintics for dogs and cats
        • Anthelmintics for horses
        • Anthelmintics for sheep, goats and cattle
        • Anti-inflammatories
        • Antibiotics
        • Complementary animal health products
        • Ectoparasiticides for dogs and cats
        • Ectoparasiticides for sheep and goats
        • Euthanasiates
        • Hormonal growth promotants
        • Immunobiological products (veterinary vaccines, antisera, biologicals)
        • Intramammary preparations
        • Intraruminal products
        • Non-prescription injectable products
        • Products containing minerals
        • Products for application to wounds
        • Professional packs of oral non-prescription products
        • Stomach tubing products
        • Teat dips and sprays
        • Therapeutic pet food products
      • Label presentation and layout
        • Information required on labels
        • Label layout
        • Printing and legibility requirements
      • Additional guidance
        • Globally harmonized system of classification and labelling
        • Promotional and display packs
        • Individual, multi- and variable dose forms
        • QR codes in the labelling and/or package leaflet
        • Removable labels for small single-dose veterinary vaccines
        • Professional packs of oral non-prescription veterinary products
    • Globally harmonized system of classification and labelling
  • Import and export
    • Importing agricultural chemicals or veterinary medicines
    • Export permits
    • Export certificates
      • Before you apply
        • About the application process
        • Timeframes and fees
        • Who can apply
        • Common types of certificates
      • What to include in your application
        • Information to be provided with a request for a section 70 certificate
    • Consent to import chemical products
  • Holders and nominated agents
    • Change a holder or nominated agent
      • Timeframes and fees for changing a holder or nominated agent
    • Definition of roles and actions for holders, nominated and authorised agents and authorising parties
  • Other government requirements
    • Drinking water guidelines – pesticides
  • Limits on use and disclosure of information
    • Limitation periods
    • Information lists
    • Authorising party
  • Application guidance
    • I want to register a new product with an existing active or new combination of approved actives
      • I want to register a new agricultural product with an existing active or new combination of approved actives
      • I want to register a new veterinary product with an existing active or new combination of approved actives
    • I want to register a new product that contains a new active constituent
      • I want to register a new agricultural product that contains a new active constituent – full assessment (Item 1)
      • I want to register a new agricultural product that contains a new active constituent – less than a full assessment (Item 2)
      • I want to register a new veterinary product that contains a new active constituent (Item 2)
    • I want to register a product that is based on an existing registered reference product
      • I want to register an agricultural product that is similar to a registered reference product and efficacy and safety and chemistry and manufacture data is required (Item 5)
      • I want to register an agricultural product that is closely similar to a registered reference product and chemistry data is required (Item 6)
      • I want to register an agricultural product that is closely similar to a registered reference product – no further data required (Item 7)
      • I want to register a veterinary product that is based on an existing registered reference product and similar efficacy, safety, chemistry and manufacture data is required (Item 5)
      • I want to register a veterinary product that is based on an existing registered reference product and is closely similar and only chemistry data is required (Item 6)
      • I want to register a veterinary product that is based on an existing registered reference product and is closely similar and data is not required (Item 7)
    • I want to register a product that is the same as a reference product
      • I want to register an agricultural product that is the same as a reference product (Item 8)
      • I want to register a veterinary product that is the same as a reference product (Item 8)
    • I want to register a product and apply for the concurrent approval of a new source of active
    • I want to register or vary a product and I need information on spray drift assessment and labelling
    • I want an additional marketing name for my existing registered product
      • I want an additional marketing name for my existing registered agricultural product
      • I want an additional marketing name for my existing registered veterinary product
    • I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only)
      • I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only) and no technical assessment is required (Item 12)
      • I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only) and a technical assessment is required (Item 14)
    • I want to vary my product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
      • I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
        • I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and no technical assessment is required (Item 12)
        • I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and a technical assessment is required (Item 14)
      • I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
        • I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and no technical assessment is required (Item 12)
        • I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and a technical assessment is required (Item 14)
    • I want to vary a re-entry or handling instruction for my product
      • I want to vary a re-entry or handling instruction for my agricultural product and no technical assessment is required (Item 12)
      • I want to vary a re-entry or handling instruction for my agricultural product and a technical assessment is required (Item 14)
      • I want to vary a re-entry or handling instruction for my veterinary product and no technical assessment is required (Item 12)
      • I want to vary a re-entry or handling instruction for my veterinary product and a technical assessment is required (Item 14)
    • I want to vary a withholding period and/or export interval
      • I want to vary a withholding period and/or export interval for an agricultural product and no technical assessment is required (Item 12)
      • I want to vary a withholding period and/or export interval for an agricultural product and a technical assessment is required (Item 14)
      • I want to vary a withholding period and/or export interval for a veterinary product and no technical assessment is required (Item 12)
      • I want to vary a withholding period and/or export interval for a veterinary product and a technical assessment is required (Item 14)
    • I want to vary the use of a product to include a new crop, animal species or situation
      • I want to vary the use of an agricultural product to include a new crop or situation and no technical assessment is required (Item 12)
      • I want to vary the use of an agricultural product to include a non-food producing crop or situation (Item 14)
      • I want to vary the use of an agricultural product to include a food producing crop or situation (Item 14)
      • I want to vary the use of a veterinary product to include a new animal species or situation and no data of a technical nature is required (Item 12)
      • I want to vary the use of a veterinary product to include a non-food species, including companion animals (Item 14)
      • I want to vary the use of a veterinary product to include a food producing animal species (Item 14)
    • I want to vary the sites of product manufacture
      • I want to vary the site of manufacture for my veterinary product and the variation involves the addition of an overseas site of manufacture that performs a primary step/s of manufacture
      • Guideline for the transfer of a manufacturing site for immunobiological products
    • I want to vary the pack size of my registered product
    • I want to vary the use of a product to include a new use, new application method, or new use instructions within an existing crop or situation (agricultural chemical products only)
      • I want to vary the use of an agricultural product to include a new use, new application method, or new use instructions within an existing crop or situation and no technical assessment is required (Item 12)
      • I want to vary the use of an agricultural product to include a new use, new application method, or new use instructions within an existing crop or situation and a technical assessment is required (Item 14)
        • I want to vary my agricultural product to make a change to the product formulation and a Prescribed Variation is required (Item 13A – only changes to non-active constituents in limited circumstances)
    • I want to vary my product to make a change to the product formulation
      • I want to vary my agricultural product to make a change to the product formulation and a Prescribed Variation is required (Item 13A – only changes to non-active constituents in limited circumstances)
      • I want to vary my agricultural product to make a change to the product formulation and no technical assessment is required (Item 12)
      • I want to vary my agricultural product to make a change to the product formulation and a technical assessment is required (Item 14)
      • I want to vary my veterinary product to make a change to the product formulation and a Prescribed Variation is required (Item 13A – only changes to non-active constituents in limited circumstances)
      • I want to vary my veterinary product to make a change to the product formulation and no technical assessment is required (Item 12)
      • I want to vary my veterinary product to make a change to the product formulation and a technical assessment is required (Item 14)
    • I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only)
      • I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only) No technical assessment is required (Item 12)
      • I want to vary my veterinary product to include a new dose rate, frequency, route of administration or application method and a technical assessment is required (Item 14)
    • I want to submit a timeshift application
    • Active constituent applications guidance
    • Training resources
      • Permits module
      • Registrations module
  • Get assistance
    • Pre-application assistance
      • Applying for pre-application assistance
      • Getting the most out of pre-application assistance
      • Pre-application assistance – timeframes and fees
      • How to withdraw a request for pre-application assistance
    • Technical assessment
  • Seek review of a decision
    • Reviewing decisions
    • Approval or variation of an active constituent or registration
    • Permits
  • Application summaries
    • Application summaries FAQs
  • Analytical methodology
  • Food safety studies for veterinary drugs used in food-producing animals

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