It's Time To Reform The Agvet Code - a draft proposal

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1. The issue: Why is reform to the Agvet Code Needed?

The Australian Pesticides & Veterinary Chemical Medicines Authority’s (APVMA) primary role is to regulate the safety and efficacy of products sold for animal use under the Agricultural & Veterinary Chemical Code (AGVET Code). The moment an animal product makes a therapeutic/physiology claim (mentions parasites or a disease/illness or anything above promoting the normal functions of the body), it is classed as a veterinary chemical product, and triggers full registration, label approval and APVMA-recognised Good Manufacturing Practice (GMP) costs and complexity small natural brands cannot carry.

The Code wasn’t written with natural products in mind. Its 1990s, claim-based architecture is technology-neutral: it cares what you claim, not whether ingredients are natural. The APVMA’s strict interpretation of the AGVET Code is not in the spirit that the law was intended and in turn, the market is tilted toward pharmaceutical incumbents and leaves the natural/organic sector effectively unrepresented. Still unsure? Consider what APVMA stands for: Australian Pesticides & Veterinary Chemical Medicines.

Lack of a Suitable Pathway

Unlike the Therapeutic Goods Administration (TGA) which offers a Complimentary Medicines Listing (AustLII) so that natural products can be listed and regulated for pre-approved, evidence-based mild-claims, the AGVET Code offers no such pathway. The 2015 AGVET Code Excluded Nutritional or Digestive Products (ENDP) update kept genuine nutrition/digestion products out of regulation, but it forbids therapeutic/physiology claims. ENDP helps sell feed, not make health claims (no matter how mild).

Result

By failing to offer a fair, practical, cost-effective path for natural products to be listed or registered with modest claims, the natural/organic sector is effectively unrepresented and at a commercial disadvantage. Additionally, natural and organic companies are being unfairly targeted and harassed in ways that are not in public interest. One such example is Augustine Approved Pty Ltd being issued almost $25,000 in fines for selling certified coconut oil and skincare. Sadly, and ironically, it is ultimately the animals that suffer because people are prevented from knowing about healthy alternatives to pharmaceuticals that can come with a broad and dangerous range of side effects.

The solution

Fix the gap with a TGA-style listed pathway for low-risk companion-animal products: allow mild, evidence-backed claims with proportionate manufacturing practises.

2. Goal: Listed Companion Animal Medicines (LCAM)

To create a department within the APVMA, TGA or ACO to manage a low-cost, low-burden listing route (not full registration) in order for natural/organic companion-animal products to make mild health claims, including parasite-related claims supported by proportionate evidence. Listed products will require local council food-business registration (or equivalent state food-safety licence), or third-party certification to HACCP/ISO 22000 or a recognised organic certification scheme, and with no mandatory GMP requirement. The proposed name is LCAM (Listed Companion Animal Medicines).

To avoid duplicate regulation, one agency should oversee LCAM; further investigation will identify which agency is appropriate.

3. Why this is balanced (and defensible)

• Cites the TGA’s proven architecture—permissible indications + certification + post-market checks—scaled to animals. (Therapeutic Goods Administration (TGA))
• Cuts regulatory cost/complexity (fees near TGA; no APVMA GMP licence), while preserving safety via ingredient positive list, species conditions, labelling, and audit powers. (APVMA, Therapeutic Goods Administration (TGA))
• Unlocks fair competition on claims. ENDP currently blocks therapeutic/parasite language altogether; L-VCM enables mild, honest claims with proportionate evidence. (AustLII Classic)

4. The model: LCAM (Listed Companion Animal Medicines) and Where it will live in law

• Produce a new part in the Agvet Code: “Part 3A — Listed Companion Animal Medicines”. Mirrors the TGA’s “listed medicines” construct in s 26A (self-certified inclusion) and s 26BF (permitted indications). (Federal Register of Legislation, AustLII)
• Two ministerial/APVMA determinations (legislative instruments), updated by APVMA:
1. Permitted Ingredients (Companion Animals) Determination — pre-approved low-risk ingredients with conditions (animal species, max doses, purity specs). Mirrors TGA’s “Permissible Ingredients” regime. (Therapeutic Goods Administration (TGA))
2. Permitted Indications (Companion Animals) Determination — a published list of pre-worded, low-level claims allowed on labels/ads (e.g., “maintains healthy skin”, “relieves mild, self-limiting itching”). Mirrors the TGA list under s 26BF. (Therapeutic Goods Administration (TGA))

5. What qualifies for listing

• Scope: Oral/topical products only for companion animals that only use permitted ingredients and only make permitted indications. Oral/topical low-risk formulations (e.g., herbs, botanicals, homeopathic, food-grade substances, natural extracts, minerals, mechanical skin/coat products). Anything beyond that stays in full registration. (Therapeutic Goods Administration (TGA))
• Not in scope: sterile injectables; scheduled poisons; products claiming to cure serious conditions (e.g., life-threatening diseases); actives requiring MRLs.
• Ingredients Criteria: Dose must be specific to species and can only be food-grade or pharmacopeial grade; non-scheduled; established animal safety margin at proposed use; special cautions for sensitive species (e.g., cats).
• Evidence: Sponsor must hold evidence matching each indication—either scientific (animal studies; or cross-species with plausible relevance) or traditional veterinary/herbal evidence—consistent with the TGA’s evidence guidance approach for listed medicines. Evidence is not pre-assessed, but must be produced on request. (Therapeutic Goods Administration (TGA))
• Advertising/label: Claims must stay within the chosen permitted indications (no implied cure and only “May assist with…” or “Has a role in…”). The APVMA can review and cancel listings for non-compliance - again mirroring TGA post-market compliance. (Therapeutic Goods Administration (TGA))

6. Quality: No mandatory GMP licence

• Today, APVMA requires GMP-licensed veterinary manufacturers; TGA requires GMP or GMP clearance for listed medicines. LCAM would explicitly exempt listed companion-animal products from APVMA GMP licensing. (apvma.gov.au, Therapeutic Goods Administration (TGA))
• Instead, require one of:
• Local council food-business registration (or equivalent state food-safety licence), or
• Third-party certification to HACCP/ISO 22000 or a recognised organic certification scheme, plus basic QC record-keeping (supplier approval, batch records, complaints/recall procedure).
• APVMA publishes a Minimum Manufacturing Standard for LCAM (guideline), scaled from the ENDP manufacturing concept (use of recognised industry codes/standards rather than full GMP). (AustLII Classic)

7. Pricing that small businesses can live with

Proposed LCAM fees (align to TGA scale):

• Listing application (per product): ~$500-$1,000 (benchmarked to TGA $1,014). (Therapeutic Goods Administration (TGA))
• Annual charge (per product): ~$400 (benchmarked to TGA $1,473). (Therapeutic Goods Administration (TGA))
• Minor variations (no technical data): $200 (TGA is $512). (Therapeutic Goods Administration (TGA))
• No GMP licence/audit fees; rely on low-cost manufacturing assurance (council/organic/HACCP). (APVMA’s current GMP fees/audits would not apply to L-VCMs.) (APVMA)
• Levy: exempt up to $100,000 in sales or flat $200 micro-levy (replacing % levy that currently has no minimum threshold). (APVMA)

What this fixes:

• Avoids $5k–$116k+ upfront APVMA registration fees for small naturals; avoids % sales levy drag; replaces GMP licence costs with practical local credentials.

8) Regulator focus

• Pre-market: automated checklist + sponsor certifications (ingredients, indications, evidence on file, manufacturing control).
• Post-market: random and targeted reviews of labels, claims and evidence; sampling/testing; substantiation notices where needed. (The TGA does this for listed medicines today.) (Therapeutic Goods Administration (TGA).

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