- Regulatory Science Network (RSN)
The Regulatory Science Network (RSN) is a network of Australian Government agencies and departments responsible for regulating chemicals and biological agents in Australia. Each agency covers specific duties, but all…
- Contents Agricultural chemical products and approved labels – 1 Veterinary chemical products and approved labels – 15 Approved active constituents – 18 Notice of cancellation at the request of the holder – 21
As a world-class regulator, the Australian Pesticides and Veterinary Medicines Authority (APVMA) participates in a number of international committees and working groups. The APVMA actively engages in the harmonisation of data guidelines with our…
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has a long-standing policy of using overseas or international assessments to facilitate the approval of new active constituents and registration of products based on the submission…
The APVMA invites comment on the proposed use of fluroxypyr on rice.
We invite written comment from 20 January 2022 to 17 February 2022 on the trade implications of this proposal.
The APVMA is able to consider comments relating to the…
The APVMA invites comment on the proposed use of imazamox and imazapyr in the product Nufarm Intercept Herbicide, for use on faba beans.
We invite written comment from 5 March 2021 to 6 April 2021 on the trade implications of this proposal.
The APVMA invites comment on the proposed use of chlorantraniliprole in the product E2Y45 Insecticide, for use on pulses.
We invite written comment from 5 March 2021 to 6 April 2021 on the trade implications of this proposal.
The APVMA…
The APVMA invites comment on the proposed use of fluxapyroxad and mefentrifluconazole in the product Revystar Fungicide, for use on wheat, barley, oats and canola.
We invite written comment from 29 March 2021 to 27 April 2021 on the trade…
The Australian Pesticides and Veterinary Medicines Authority (APVMA) invites comment on the proposed use of fludioxonil and pydiflumetofen in the product Miravis Star Adepidyn Technology Fungicide, for use on canola and pulses.
We invite…
The end date for this consultation has been extended to 28 February 2021
The Australian Pesticides and Veterinary Medicines Authority (APVMA) invites comment on the proposed use of amitraz in the product APIVAR 500 mg…
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Applying for permits
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Data guidelines
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Veterinary data guidelines
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Chemistry and manufacture (Part 2)
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- Residues (Part 5A)
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Labelling Codes
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Specific labelling requirements
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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
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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
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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
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I want to register a new product with an existing active or new combination of approved actives
- Get assistance
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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
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Active constituents
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Regulation
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Chemical review
- Chemical review process
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Listing of chemical reviews
- Reconsiderations listed in the Ministerial Direction
- List of voluntary cancellations at the request of the holder
- Voluntary suspensions at the request of the holder
- Prioritisation of chemicals nominated for review
- 2010 spray drift label review nominations
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- Hormonal growth promotants
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Manufacturing
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About
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About us
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Section 6A Guidelines
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