The Australian Pesticides and Veterinary Medicines Authority (APVMA) has finalised updates to the Good Manufacturing Practice (GMP) Audit Procedure.
BackgroundIn Australia, manufacturers of veterinary chemical products must be appropriately…
Click on the tabs for more information about the status of each phase in the review process. For more information about how each phase is conducted, please read about the reconsideration process.
- Background
The APVMA is seeking feedback on its revised stakeholder engagement model.
The APVMA has reviewed its engagement practices based on:
recommendations made by independent reviews of the APVMAthe findings of the 2024 stakeholder and… The Agricultural Chemicals Working Group facilitates engagement between the APVMA and registrants, permit holders, industry representatives, and other regulated entities on practical and operational matters related to the regulation of agricultural…
The Veterinary Medicines Working Group facilitates engagement between the APVMA and registrants, permit holders, industry representatives, and other regulated entities on practical and operational matters related to the regulation of veterinary…
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Registrations and permits
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Chemical product registration
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What to include in your application
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Guide to completing an online application
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After you apply
- Primary and secondary applications
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After registration
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Applying for permits
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Data guidelines
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Agricultural data guidelines
- Adopted international technical guidance material
- Chemistry and manufacture (Part 2)
- Toxicology (Part 3)
- Metabolism and kinetics (Part 4)
- Residues (Part 5A)
- Overseas trade (Part 5B)
- Occupational health and safety (Part 6)
- Environment (Part 7)
- Pesticides efficacy and crop safety general guideline (Part 8)
- 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
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Veterinary data guidelines
- Adopted international technical guidance material
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Chemistry and manufacture (Part 2)
- Toxicology (Part 3)
- Metabolism and kinetics (Part 4)
- Residues (Part 5A)
- Overseas trade (Part 5B)
- 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
- Module descriptors
- Risk assessment manuals
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Agricultural data guidelines
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Labelling Codes
- Agricultural Labelling Code
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Veterinary Labelling Code
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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
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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
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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
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Specific labelling requirements
- Globally harmonized system of classification and labelling
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Import and export
- Holders and nominated agents
- Other government requirements
- Limits on use and disclosure of information
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Application guidance
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I want to register a new product with an existing active or new combination of approved actives
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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)
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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 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
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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)
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I want to vary my product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
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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)
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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)
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I want to vary my agricultural product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions
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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)
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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)
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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)
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I want to vary the sites of product manufacture
- I want to vary the pack size of my registered product
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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)
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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)
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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)
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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
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I want to register a new product with an existing active or new combination of approved actives
- Get assistance
- Seek review of a decision
- Application summaries
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Chemicals and products
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Active constituents
- APVMA standards for active constituents for use in agricultural chemical products
- Active constituents exempt from the requirements of APVMA approval for use in agricultural or veterinary chemical products
- General list of impurities and classes of impurities of toxicological concern for agricultural active constituents
- Approval of active constituents
- Uniform expression of active constituents
- FAISD Handbook
- Health based guidance values
- Pesticides and veterinary residues
- Scheduled drugs and poisons
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Active constituents
- Regulation
- Resources
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About
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About us
- Agvet chemical regulation
- Use of agvet chemicals in Australia
- Access to information held by the APVMA
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Accountability and reporting
- Careers
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Communication and decision making
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Section 6A Guidelines
- Overarching principles and processes for the effective and efficient regulation of agricultural and veterinary chemical products
- Approvals and registrations
- Permits
- Remitting certain application fees under the Agvet Code
- Licences
- Recategorising applications
- Requesting information from applicants
- Limits on use of information
- Reconsidering approvals and registrations
- Varying relevant particulars and conditions
- Formulation types
- Previous s 6A Guidelines
- Communication between applicants and the APVMA
- Data handling by the APVMA
- External advice
- Transparency
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Section 6A Guidelines
- Stakeholder engagement
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International collaboration
- Our website and your privacy
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About us
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Registrations and permits
- Search products and permits
- Chemical product registration
- Applying for permits
- Data guidelines
- Labelling Codes
- Import and export
- Holders and nominated agents
- Other government requirements
- Limits on use and disclosure of information
- Application guidance
- Get assistance
- Seek review of a decision
- Application summaries
- Chemicals and products
- Regulation
- Resources