APVMA Cost Recovery Arrangements
The APVMA is funded by fees, charges and levies imposed on the industry it regulates. Chemical companies pay fees for the APVMA to evaluate registration proposals and a levy based on the wholesale sales of chemical products.
29 November 2012—The APVMA has published the Cost Recovery Impact Statement covering the period 1 July 2013 – 30 June 2015
26 October 2012—The Department of Agriculture, Fisheries and Forestry (DAFF) has published the initial public submissions (external site) received for a First-principles Review of the cost recovery arrangements for the APVMA and aims to examine and recommend options to strengthen the financial sustainability, transparency and accountability of the APVMA’s cost recovery arrangements.
The review is focused on the structure of the APVMA’s cost recovery framework. The review does not include consideration of the scope and level of the APVMA’s regulatory activities.
An invitation from DAFF for further submissions will follow the development of a new draft cost recovery framework (expected to be released in the first half of 2013).
For more information on the First-principles Review—go to the DAFF website (external site).
The current APVMA cost recovery arrangements were implemented in July 2005, and reviewed in 2008. At this time, we sought stakeholder input into the process and released a draft cost recovery impact statement (CRIS) in December 2008.
In early 2010, the then Minister for Agriculture, Fisheries and Forestry, decided that a 10 per cent increase in fees would be applied from 1 July 2010, pending development of a revised cost recovery impact statement.
The 10 per cent increase applied to the annual fee on product registrations, new application fees for evaluation and approval (category and modular), hormonal growth promotants notification number application and renewal fees, Certificate of Export fees, new good manufacturing practice licences and database information fees. Levies did not change. These changes were given effect by a variation to the 2005 CRIS.
The 10 per cent increase was an interim measure. Further changes to the APVMA's cost recovery arrangements were to be considered in the context of expected reforms to the operation of the APVMA announced in the government's August 2010 election commitment for the Better Regulation of Agricultural and Veterinary Chemicals. The government announced its intention to proceed with the Better Regulation of Agricultural and Veterinary Chemicals in early 2011─details of the proposed reforms can be found on the DAFF website (external site).
In December 2011, we published a discussion paper that proposed further interim cost recovery arrangements for the APVMA in 2012–15. The paper focused on ensuring appropriate and sustainable revenue to enable efficient and effective administration of agvet chemical regulation and to minimise risks while a longer-term First-principles Review (external site) is being undertaken by the Department of Agriculture, Fisheries and Forestry.
The December 2011 discussion paper also proposed a number of changes to the current arrangements for the recovery of costs associated with the assessment of compliance with Good Manufacturing Practice (GMP), which affects manufacturers of veterinary medicines in the Australian marketplace and registrants of imported veterinary products. Following consultation with a number of veterinary medicines industry groups we developed an alternate proposal for the recovery of costs associated with the assessment of compliance with GMP.
Following consultation with a number of veterinary medicines industry groups we developed an alternate proposal for the recovery of costs associated with the assessment of compliance with GMP.
This alternative proposal was presented in a supplementary discussion paper on the Cost Recovery of Compliance with GMP was published in May 2012. Submissions closed on 15 June 2012 and have been published online.
A CRIS was then developed based on the two discussion papers and the consultation undertaken.
The Minister for Agriculture, Fisheries and Forestry approved the CRIS in November 2012.
The Cost Recovery Impact Statement (PDF, 1.40Mb) | (DOC, 1.12Mb) commences on 1 July 2013 (subject to the passage of the Better Regulation of Agricultural and Veterinary Chemicals legislative reforms (external site)).
The interim cost arrangements outlined above will be in place while the First-principles Review of the cost recovery arrangements for the APVMA is undertaken by the Department of Agriculture Fisheries and Forestry. This review will examine all existing fees and charges.
The Terms of Reference for this First-principles Review can be found on the DAFF website (external site).
- Cost Recovery Impact Statement (PDF, 1.40Mb) | (DOC, 1.12Mb)
- Seeking input into an alternate proposal for the recovery of costs for assessment of compliance with Good Manufacturing Practice
- Seeking input to the APVMA interim cost recovery arrangements 2012–15 – 14 December 2011
- Better Regulation of Pesticides and Veterinary Medicines
- Review of APVMA cost recovery arrangements - 5 August 2011
- Changes to cost recovery arrangements now in effect - 1 July 2010
- Ministerial decision on cost recovery arrangements - 5 May 2010
- 2005 Cost Recovery Impact Statement report (external site)
Executive Director, Corporate Services
PO Box 6182
Kingston ACT 2604
Ph: (02) 6210 4844
Fax: (02) 6210 4874