This content only applies to transition applications that were received before 1 July 2014. The content will be relevant for these applications until 30 June 2015.
For all other applications, including new applications, please visit www.apvma.gov.au
Manufacture of Veterinary Chemicals (Good Manufacturing Practice)
Veterinary chemical products are subject to a registration process that requires them to be fit for their intended use and to not place treated animals or users at risk due to inadequate safety, quality or efficacy. Veterinary chemical products must be manufactured in such a way that they comply with their registered particulars and that there is batch-to-batch consistency.
The ultimate responsibility for attaining these quality objectives lies with senior management, but their attainment also requires the participation and commitment of all staff, at all levels, within the manufacturing organisation. In order to achieve these objectives, the manufacturer must have in place a comprehensively designed, adequately resourced and correctly implemented system of quality assurance, incorporating the principles of good manufacturing practice (GMP).
View the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products (PDF, 507kb) and the Agricultural and Veterinary Chemicals Instrument No 1 (Manufacturing Principles) 2007 (ComLaw).
The APVMA operates two programs that monitor industry compliance with manufacturing quality standards and GMP:
- The Manufacturers’ Licensing Scheme for veterinary products manufactured in Australia and
- The Overseas GMP Scheme for veterinary products manufactured overseas.
GMP Compliance Assessment Fees
The fees charged by the APVMA for the Manufacturers Licensing Scheme prior to 1 July 2013 only recovered a small proportion of the total operating costs associated with this program and did not meet the principles outlined within the Australian Governments Cost Recovery Guidelines. As such the APVMA had to make changes to our Cost Recovery Arrangements. These changes underwent consultation in December 2011 and May 2012 and the final Cost Recovery Impact Statement was approved by the Minister in late 2012.
The Agricultural and Veterinary Chemicals Code Regulations were signed on 24 June 2013. The changes specified within the Amendment to the Cost Recovery Impact Statement commenced on 1 July 2013.
The following fees are now applicable:
- an annual licence fee of $7500.00 applies to all Category 1 licensed Manufacturers
- an annual licence fee of $7500.00 applies to all holders of multi Category licences (Manufacturers who hold licences to manufacture Category 2 and 3, Category 2 and 4, Category 2, 3, and 4 and Category 3 and 4 products)
- an annual licence fee of $5000.00 applies to Single Category manufacturers (Category 2, Category 3 or Category 4 products only)
- an annual licence fee of $1800.00 applies to all Category 6 licence holders
- a licence application fee of $900.00 applies for each new licence application received after 1 July 2013
- a licence variation application fee of $1800.00 applies for all partial audits for extension of licence scope conducted after 1 July 2013
- an annual overseas GMP compliance assessment fee of $1000.00 applies per overseas site of manufacture used per registrant
There will be an increase in costs for manufacturers as the full cost of compliance with Good Manufacturing Practice is recovered from those that benefit from the scheme. For those manufacturers who are also registrants the cost increase will be either fully or partially offset by a reduction in the levy rates for sales of the products. It should also be noted that registrants of product manufactured outside of Australia will also now significantly contribute to the cost of running the Overseas GMP Scheme.
This change in the fees will result in a decrease in the amount payable by product registrants in levies. Information regarding the change in levy rates is available in the Cost Recovery Impact Statement.
Frequently asked questions are avaialble including further information about the fees and the reason for the changes.
Good Manufacturing Practice
- Manufacture of veterinary chemicals
Phone: +61 2 6210 4899
Fax: +61 2 6210 4741