The Australian Pesticides and Veterinary Medicines Authority (APVMA) invite stakeholders and industry participants to review and provide feedback on the Draft revised Australian code of Good Manufacturing Practice for veterinary chemical products (the GMP Code). We welcome your submissions to ensure the final code remains practical, modern, and legally robust.
Background
In Australia, manufacturers of veterinary chemical products involved in any step of the manufacturing process must be appropriately licensed by the APVMA, unless a specific exemption applies.
The APVMA administers the Manufacturers’ Licensing Scheme, and the ongoing maintenance of these licenses.
Legal authority for GMP Code
The legal enforcement of manufacturing quality relies on a multi-tiered legislative framework. This structure connects primary legislation down to specific administrative actions:
- Section 23 of the Agricultural and Veterinary Chemicals Act 1994 empowers the Minister or the APVMA to formally determine the Manufacturing Principles as a legislative instrument.
- Manufacturing Principles legally mandate that a manufacturer must establish a quality management framework. This instrument explicitly states that complying with the GMP Code is how a manufacturer fulfills those principles.
- Part 7 of the Agricultural and Veterinary Chemicals Code Regulations 1995 (specifically Regulations 59 through 59E) provides the explicit administrative criteria, fees, and audit rules that the APVMA uses to police the licensing system.
To maintain the quality of veterinary preparations and secure their compliance in international trade, the regulatory framework relies on 2 distinct, complementary documents working in conjunction with the Manufacturing Principles:
- The GMP Code: Defines the overarching quality standards and rules.
- The GMP Procedure: Sets out the practical, operational steps required to satisfy those standards. The Procedure was updated in March 2025.
The current iteration of the framework no longer meets the needs of a modern regulatory environment:
- The current GMP Code was published in 2007 and has not been updated since.
- The 2007 text fails to reflect significant modern developments in manufacturing technologies, digital document management, and pharmaceutical industry practices, both locally and internationally.
To bridge these gaps, the updated GMP Code will be supported by a newly produced suite of guidance documents to assist manufacturers in achieving practical compliance, when the GMP Code becomes effective.
Submissions
We invite submissions from 17 August 2026 to 20 November 2026 on the Draft revised Australian code of Good Manufacturing Practice for veterinary chemical products.
Change Record
To assist you we have prepared a Change Record document. The Change Record document lists every clause of the newly proposed draft document 2026 version. It maps whether text is modified, brand new, or remaining identical to what is active today (which is the 2007 document). This allows industry stakeholders to see exactly where the proposed changes differ or are new, it also allows tracking as to where those clauses were in 2007 code.
Where there is a minor change, such as from the word ‘shall’ or ‘must’, to ‘should’, this has been marked as unchanged. The practical application is unchanged, but improves consistency within the document.
You are invited to use the Change Record document to record specific concerns or feedback against individual clauses, in this case, please return the excel via email to mls@apvma.gov.au. The intent is to provide stakeholders with a tool allowing you to track where information or clauses are currently in the 2007 document, making the comparison easier, and identifying specific concerns.
Please note: Submissions will be published on the APVMA’s website, unless you have asked for the submission to remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (see public submission coversheet).
Please lodge your submission with a public submission coversheet, which provides options for how your submission will be published.
Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.
Please send your written submission and coversheet by email or post to:
Email: mls@apvma.gov.au
Post:
GPO Box 574
Canberra ACT 2601
James Deller
Executive Director
Science & Assurance Branch
Australian Pesticides and Veterinary Medicines Authority
GPO Box 574
Canberra ACT 2601