Risk Compendium Volume 1: Principles that underpin APVMA regulatory activities
A key component of the Better Regulation reforms is the development of a comprehensive risk compendium that explains how the APVMA applies the suite of agvet legislation, its policies and its decision-making processes. The Risk Compendium will also aid understanding of the APVMA's regulatory requirements and provide guidance about the types of information necessary to inform its scientific assessment processes.
Volume 1 of the risk compendium comprises a series of framework documents that outline the principles that underpin APVMA's regulatory activities. Each framework will introduce key elements of a specific regulatory activity including an overview of the critical processes, the application of statutory tests and/or an outline of key steps that the APVMA or an applicant must take.
Note: these draft frameworks reflect the current legislative arrangements and set out the key areas of change arising from the Better Regulation reform process. Some frameworks were previously published to this website that to reflect the draft Agricultural and Veterinary Chemicals Legislation Amendment Bill 2011 (external site).The framework documents are now being updated to reflect the legislative arrangements proposed in the revised draft Bill 2012 (external site) released by the Department of Agricultural, Fisheries and Forestry in October 2012. The updated frameworks are identified below with a publishing date of October 2012.
These frameworks have been published in DRAFT form to support our stakeholders during the legislative reform process and provide operational context to the new Bill (external site). We will update these frameworks in the coming weeks to provide a more accessible option for viewing the content and to reflect any changes in the legislative reform process.
- Overview of APVMA Operations and Future Direction (revised October 2012)
- Registration (released October 2012)
- Continuation (Re-registration and Re-approval) —drafting, due for revision in October 2012
- Chemical Review (Reconsideration) (released October 2012)
- Permits—drafting, due for revision in October 2012
- Manufacturing Quality and Licensing Scheme (released October 2012)
- Compliance and Enforcement (revised October 2012)
- Risk Analysis (drafting)
The draft Overview document provides an introduction to the operations of the APVMA and the suite of reforms (external site) that will transform those operations. It introduces the APVMA Risk Compendium and is intended to assist stakeholders to engage and participate in the consultative process of reforming APVMA operations and business improvement.
- Download the draft Overview of APVMA Operations and Future Direction (October 2012) (PDF, 991kb) | (DOC, 11.5MB)
How the compendium supports Business improvement
One of the reform measures proposed by the Minister for Agriculture, Fisheries and Forestry through the Better Regulation Partnership is substantial Business improvement (external site) which aims to;
- improve the quality of applications received by the APVMA, and
- reduce time spent by the APVMA in dealing with incomplete or poor quality applications.
Business improvement will be delivered through amendments to existing legislation (external site), and include proposed changes to:
- how the APVMA can receive and manage information
- the statutory timeframes for assessment and evaluation, including the way they are measured, and
- the introduction of statutory timeframes for chemical review (reconsideration of existing chemicals).
Business improvement places an onus on would-be registrants to submit complete and correct applications to the APVMA. To support applicants to deliver these standards the compendium will provide detailed information about the requirements for an application including comprehensive information on data requirements and the corresponding category requirements.
Industry Reference Groups
Stakeholders can inform the refinement of elements of the APVMAs business transformation and the development of the risk compendium through participation in one of the targeted industry reference groups.
For enquiries about the reforms to the regulation of agricultural and veterinary chemicals.
+61 2 6210 4877
Fax: +61 2 6210 4813