The APVMA has released a full rewrite of the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products for public consultation — the “GMP Code” that, via section 23 of the *Agricultural and Veterinary Chemicals Act 1994* (Cth) and the Manufacturing Principles it supports, sits underneath every manufacturing licence the APVMA issues (administered under Part 7 of the *Agricultural and Veterinary Chemicals Code Regulations 1995*, regs 59–59E)[RS1] . Depending on where a business sits in the supply chain, this is either welcome modernisation or a genuine compliance headache.

The Code was last consolidated in 2007, bringing together separate codes for veterinary preparations and for feed-milling/stock-feed premixes. The APVMA’s own background notes to the review say the driver is that “manufacturing technologies, quality systems and international GMP expectations have also evolved significantly” since then, with “greater emphasis… now placed on quality risk management, continual improvement, management oversight, validation and verification activities, supplier assurance, and the use of electronic systems and records,” reflecting a global shift toward “more risk-based approaches” to manufacturing oversight.

That shift shows up as concrete new obligations, not just rhetoric. The draft adds a standalone Quality Risk Management chapter requiring a documented QRM procedure, with written, Quality-Department-approved risk reports reviewed annually (clauses 1.21–1.26). It adds a Validation Master Plan framework requiring risk-based (not retrospective) qualification and validation across the full equipment, facility and system lifecycle (1.27–1.32). And it adds an entirely new Computer Systems chapter — audit trails for GMP-relevant data changes, controlled electronic signatures, validated data migration, contingency and disaster-recovery planning, and periodic checks of archived electronic records (Chapter 6). Annual product quality reviews (PQRs) are also formalised against an ISO 22000 benchmark. None of this is unusual by the standards of PIC/S GMP or EU/US GMP — it reads like those frameworks translated into the veterinary context — but it is new to this Code.

That is exactly why the impact splits along manufacturing footprint lines, in DTS’s professional assessment. A multinational supplying the Australian market typically already manufactures somewhere in its network to PIC/S, EU or US FDA GMP, where a documented QRM programme, validated computer systems with audit trails and e-signatures, and formal validation master plans are already business as usual.

A local, Australia-only manufacturer currently compliant with the 2007-era Code may have none of these systems formalised. Defining a documented QRM programme, building a validation master plan, upgrading or revalidating computer systems for audit-trail and e-signature capability, and formalising annual PQRs against ISO 22000 are real projects — quality-system redesign, IT investment, retraining, and audit preparation — on a regulatory timeline the manufacturer doesn’t control. The reform’s compliance cost, in other words, lands disproportionately on the domestic base it is nominally meant to bring up to a common standard.

Local manufacturers should not wait for a final version before assessing exposure — a targeted gap analysis against the QRM, Validation Master Plan and Computer Systems chapters specifically (the three areas most likely to require new systems rather than incremental change) is the sensible starting point, alongside a considered submission during the comment period.  Submissions are invited until 20 November 2026.

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< This article is a working draft prepared for general information. It does not constitute regulatory or legal advice, and no compliance conclusion should be drawn from it. The commentary on differential impact between local and multinational manufacturers is DTS’s professional assessment, not a finding stated by the APVMA. >