Agricultural and Veterinary Chemicals Legislation Amendment (Improvements) Regulations 2021
On 16 December 2021, the Agricultural and Veterinary Chemicals Legislation Amendment (Improvements) Regulations 2021 were made to improve the efficiency and effectiveness of the national system for regulating agvet chemicals. The changes amend the:
- Agricultural and Veterinary Chemicals Code Regulations 1995
- Agricultural and Veterinary Chemicals (Administration) Regulations 1995.
Key measures include:
- prescribing certain kinds of information that the Australian Pesticides and Veterinary Medicines Authority (APVMA ) may take into account during the assessment period for an application
- authorising the APVMA to set application fees and assessment periods certain for applications
- requiring the APVMA, when publishing the summary of relevant applications, to include a statement that relevant protection periods or limitation periods may be extended as a result of granting the application
- declaring that certain voluntary recall notices submitted to the APVMA do not need to be published
- providing the APVMA with the ability to issue infringement notices for alleged contraventions of civil penalty provisions relating to:
- failing to comply with annual return reporting or record keeping requirements
- providing the APVMA with false or misleading information or documents
- failing to notify the APVMA of a voluntary recall.
Public consultation on these changes was conducted from 12 December 2018 to 20 February 2019 as a part of the consultation on the Agricultural and Veterinary Chemicals Legislation Amendment (Timeshift Applications and Other Measures) Regulations 2019.
Further public consultation was conducted from 14 July 2021 to 27 August 2021 as a part of the consultation on the Agricultural and Veterinary Chemicals Code Amendment (Miscellaneous Measures) Regulations 2021.
Visit Have Your Say for more information on this consultation (now closed) including the submissions received.
Agricultural and Veterinary Chemicals Code Amendment (Miscellaneous Measures) Regulations 2021
On 16 December 2021, the Agricultural and Veterinary Chemicals Code Amendment (Miscellaneous Measures) Regulations 2021 were made to improve access to agvet chemicals. The changes amend the Agricultural and Veterinary Chemicals Code Regulations 1995.
Key measures include:
- changing the definition of ‘minor use’ to implement an agreed approach by Australia’s Commonwealth, state and territory agricultural ministers to improve the harmonisation of off-label access to agvet chemicals
- providing for the APVMA to develop a standard setting out the allowed differences for constituents in a registered chemical product
- excluding a limited range of enzyme products from regulation as agvet chemical products.
Public consultation on these changes was conducted from 14 July 2021 to 27 August 2021.
Visit Have Your Say for more information on this consultation and to view the submissions received.
Agricultural and Veterinary Chemicals Code (Conditions of Approval or Registration) Order 2021
On 13 July 2021, the Agricultural and Veterinary Chemicals Code (Conditions of Approval or Registration) Order 2021 was made to ensure that the APVMA can respond appropriately should it establish that registered agricultural chemical products (or approved active constituents for such products) are not compliant with any licencing requirement (however described, for example manufacturing permits, certificates or authorisations) in the country of manufacture.
The Order protects the credibility and reputation of Australia’s regulatory controls for agricultural chemicals. The reputation of Australia’s regulatory controls for veterinary chemical products is already sufficiently protected by the existing system (Good Manufacturing Practice).
Agricultural and Veterinary Chemicals Legislation Amendment (Timeshift Applications and Other Measures) Regulations
On 21 March 2019, the Agricultural and Veterinary Chemicals Legislation Amendment (Timeshift Applications and Other Measures) Regulations 2019 were made to improve the efficient and effective regulation of agvet chemicals.
The changes amended the:
- Agricultural and Veterinary Chemicals (Administration) Regulations 1995
- Agricultural and Veterinary Chemicals Code Regulations 1995
- Agricultural and Veterinary Chemical Products (Collection of Levy) Regulations 1995.
Key measures include:
- extending the range of application types that can be assessed as timeshift applications
- providing for greater use of disallowable ministerial orders
- removing APVMA regulation of certain substances
- modernising hormonal growth promotant supply requirements
- addressing an anomaly about advertising in agvet chemical legislation
- clarifying when the APVMA can use information provided by another party to support the registration of a proposed chemical product
- allowing for certain approvals to be dealt with simultaneously as part of an application for registration.
Public consultation on these changes was conducted from 12 December 2018 to 20 February 2019.
Consultation
The following submissions were received in response to the original consultation document and exposure draft on proposed changes to agricultural and veterinary chemical regulations.
Download
| Document | File size |
|---|---|
| Animal Medicines Australia PDF | 580 MB |
| Australian Competition & Consumer Commission PDF | 168 KB |
| CropLife Australia PDF | 548 KB |
| National Farmers' Federation PDF | 552 KB |
| The Veterinary Manufacturers and Distributors Association Ltd PDF | 124 KB |
Published submissions may not meet Australian Government accessibility guidelines as they have not been prepared by the department.
Although the period for submissions has closed, the original consultation document and exposure draft is still available to view.
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If you have difficulty accessing these files, visit web accessibility for assistance.
The exposure draft set out information about the proposed changes.
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These publications were not prepared by the department and may not meet Australian Government accessibility guidelines. If you require an accessible version of the publication, please contact the department.