The Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 (Improvements Bill) passed through Parliament on 1 December 2021.
On 7 December 2021, the Improvements Bill received the Royal Assent and is now the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Act 2021 (Improvements Act). The Improvements Act will be incorporated into the compilations of the Agricultural and Veterinary Chemicals Code Act 1994, the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994.
The measures (parts) in the Act are described in the Explanatory Memorandum.
Implementation of the measures will be staggered, with some to commence on Royal Assent or within the next 3, 6 or 12 months.
You can subscribe to receive email updates from the Australian Pesticides and Veterinary Medicines Authority (APVMA) to be notified as the implementation of the following measures occurs. Questions about the Improvements Act may be directed to the APVMA Enquiries Team.
The Board
Schedule 2 of the Improvements Act describes the APVMA Board and how it will be established and operate. The Board is the body established under the Agricultural and Veterinary Chemicals (Administration) Act 1992 to govern the APVMA and conduct financial, risk and audit oversight amongst other functions and duties.
On 3 March 2022, the Governor-General signed the proclamation that brought these changes into effect. As a result, from 4 March 2022, the Accountable Authority of the APVMA is the Board under the Public Governance, Performance and Accountability (PGPA) Act 2013.
On Friday 8 April 2022, the then Minister for Agriculture and Northern Australia announced the members of the APVMA Board.
The list of Board members and the APVMA's organisational structure is available on our website.
Other improvements
Schedule 1 of the Improvements Act contains the ‘other improvements’. The tables below contain details of these reforms and their commencement dates.
- Amendments commenced 7 December 2021 to 1 January 2022
- Amendments commenced 7 March 2022
- Amendments commenced 7 June 2022
- Amendments commenced 7 December 2022
Part* |
Description |
Stakeholder implications |
---|---|---|
3 |
This amendment extends the period of time (up to a maximum of 5 additional years) during which the APVMA must not use information subject to data restrictions (protected information and information with limits on use) to support the registration, variation or reconsideration of another chemical product or active constituent without the owner of the information providing consent. |
This provides an incentive for the holders to register certain uses (priority uses) of chemical products.
The priority uses have been identified by growers and other stakeholders.
A legislative instrument has been developed by the Department of Agriculture, Fisheries and Forestry that details these priority use patterns. |
7 |
Applications for variation of an active constituent or chemical product: This amendment enables the APVMA to vary, as part of a variation application, the relevant particulars or conditions of an active constituent, a chemical product, or a label for containers for a chemical product, in a way other than as set out in the original application for variation.
This may include granting part of a variation application. |
In practice, the APVMA works with applicants to vary their applications where an application might otherwise be refused.
If the APVMA proposes to vary an active constituent, product or label in a way other than what was set out in a variation application, an applicant would have the opportunity to provide a written submission.
This situation already applies for registration applications and is very rarely used. |
8 |
This amendment enables the APVMA to deal with suspended label approvals or registrations and to address the reason for a suspension.
It will also allow holders to request a suspension of an approval or registration. |
A holder can apply to vary the relevant particulars and conditions for a label approval or product registration that is suspended, provided the application relates to the reasons for the suspension.
This means that the issues with a label or product that led to its suspension can be rectified prior to a suspension being lifted.
Previously, holders could only request cancellation of their approval or registration. This amendment allows them to request a suspension if this is needed. |
9 |
This clarifies the offence of providing false or misleading information or documents to the APVMA, orally or in writing, and allows the APVMA to seek civil penalties. |
Clarification of the law and the prospect of civil penalties for relevant contraventions. This is expected to encourage compliance with the Administration Act and Agvet Code and provides the APVMA greater flexibility to respond to circumstances of non-compliance. |
10 |
This amendment provides the APVMA with more comprehensive grounds for suspending or cancelling approvals or registrations where information is provided that is false or misleading. This includes information provided in certain applications that were not previously covered and by persons other than the holder. |
The provision of false or misleading information may lead to suspension or cancellation of active constituent approvals and product registrations in more circumstances.
The APVMA will still provide the holder with a notice of reasons for a proposed decision and review processes continue to apply. |
11 |
This amendment to the Agvet Code requires persons to inform the APVMA when they are undertaking certain voluntary recalls and requires the APVMA to publish such recalls.
This person need not be the holder of an approval or registration, as there are a number of different points in the supply chain of a chemical product where a voluntary recall may occur. |
Persons undertaking certain voluntary recalls will be required to inform the APVMA. |
12 |
This amendment requires holders of label approvals, and applicants for label approvals and variations to provide relevant information to the APVMA.
Relevant information is information that shows an active constituent, chemical product or label may not meet the statutory criteria or contradicts information already provided or held by the APVMA.
This will ensure the APVMA has access to the latest information related to an active constituent, chemical product or product label to ensure it continues to meet safety, efficacy and trade criteria.
|
This provision extends requirements that already apply to applicants and holders of product registrations and active constituent approvals. Holders of approval of a label for containers now have the same obligations to provide relevant information as other holders. |
* Each measure is referred to as a ‘Part’ in the Improvements Act and the Explanatory Memorandum. For example, Part 1 of the Act describes measure 1.