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Chemistry and manufacture (Part 2)
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Residues (Part 5A)
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Residues (Part 5A)
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Environment (Part 7)
Roadmap for insect pollinator risk assessments in Australia
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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
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Veterinary data guidelines
Adopted international technical guidance material
Chemistry and manufacture (Part 2)
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Chemistry and manufacture (Part 2)
Chemistry and manufacture of active constituents (Part 2)
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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)
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Metabolism and kinetics (Part 4)
Comparative metabolism studies, selection of marker residues and ratios of marker residues to total residues
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Residues (Part 5A)
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Overseas trade (Part 5B)
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Overseas trade (Part 5B)
Veterinary drug residues in food commodities and overseas trade
Occupational health and safety (Part 6)
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Specific guidelines
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Guidelines for data to support efficacy and safety of teat disinfectants
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Crop groupings project – consolidated responses to phase one consultation
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Crop groupings project – consolidated responses to phase one consultation
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Specific labelling requirements
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Anthelmintics for dogs and cats
Anthelmintics for horses
Anthelmintics for sheep, goats and cattle
Anti-inflammatories
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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
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Label presentation and layout
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Additional guidance
Globally harmonized system of classification and labelling
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QR codes in the labelling and/or package leaflet
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Professional packs of oral non-prescription veterinary products
Globally harmonized system of classification and labelling
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Export certificates
Before you apply
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Application guidance
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 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
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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)
I want to register a product that is based on an existing registered reference product
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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
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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
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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)
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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)
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 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
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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)
I want to vary my veterinary 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 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
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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)
I want to vary a withholding period and/or export interval
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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)
I want to vary the use of a product to include a new crop, animal species or situation
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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)
I want to vary the sites of product manufacture
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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)
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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)
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 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
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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)
I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only)
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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
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Active constituents
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Approval of active constituents
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FAISD Handbook
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Health based guidance values
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2,4-D
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2,4-D
Technical note on standards for the classification of nozzles in Australia
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Bromoxynil
Mercury fungicides
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Hormonal growth promotants
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Levy audit program
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COVID-19: advice for veterinary medicine manufacturers and holders
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Good Manufacturing Practice
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Manufacturing Principles
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Chemicals in the news
1080
Cannabis in veterinary chemical products
Chlorpyrifos
Glyphosate
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Glyphosate
Glyphosate in Australia
How does the APVMA determine an agricultural chemical is safe to use in Australia?
The APVMA’s previous assessments of glyphosate
The IARC assessment explained
How is glyphosate regulated around the world?
Neonicotinoids
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Using chemicals
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Using chemicals correctly
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Spray drift
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Spray Drift Management Tool permit
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About
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APVMA basics
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APVMA basics
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2024 cost recovery review
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Agvet chemical regulation
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Use of agvet chemicals in Australia
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Access to information held by the APVMA
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Annual product sales data
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APS Employee Census
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Information Publication Scheme
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June 2024 performance report
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June 2024 performance report
Applications in detail
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March 2024 performance report
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March 2024 performance report
Applications in detail
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September 2024 performance report
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September 2024 performance report
Applications in detail
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December 2023 performance report
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December 2023 performance report
Applications in detail
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September 2023 performance report
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September 2023 performance report
Applications in detail
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Graduate Development Program
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Section 6A Guidelines
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Section 6A Guidelines
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Approvals and registrations
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Previous s 6A Guidelines
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Communication between applicants and the APVMA
Service charter
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