TGA co-packing: what brands need to verify
Packing and labelling a complementary medicine in Australia may be a regulated manufacturing step. Before work begins, the sponsor must confirm that every manufacturer involved holds the licence or clearance required for the relevant step, product category and dosage form. This guide explains the practical checks to make before appointing a co-packer.
This article summarises public TGA guidance for operational planning. It is not regulatory or legal advice. Sponsors should confirm their obligations with the TGA or a qualified regulatory adviser.
Why Nutraceuticals Sit Apart from Food and Pharma
Australia regulates supplements under the Therapeutic Goods Act 1989, administered by the TGA. They are not foods regulated by Food Standards Australia New Zealand (FSANZ), even when they look like food (protein bars with therapeutic claims, fortified powders, gummy multivitamins). They are also not full pharmaceuticals subject to the same scrutiny as prescription drugs.
They sit in their own category called complementary medicines, which includes vitamins, minerals, herbs, nutritional supplements, homeopathic medicines and aromatherapy products. The category is regulated proportionally to risk, but the GMP and labeling rules still apply.
The practical implication for contract packing is that a facility certified for food packing under HACCP cannot lawfully pack a Listed complementary medicine. The facility needs a current TGA manufacturing licence covering the dose form being packed (oral solid, oral liquid, powder, soft gel, etc.). Sponsors who get this wrong discover the gap during their first ARTG audit, and the discovery is expensive.
Listed vs Registered: AUST L and AUST R
The TGA uses distinct pathways for listed, listed assessed and registered medicines. The applicable pathway affects claims, evidence and regulatory assessment.
Registered complementary medicine applications have separate application and evaluation fees. From 1 July 2026, the TGA schedule lists application fees from A$697 to A$3,629 and evaluation fees from A$3,996 to A$46,444, depending on the application category. Check the current TGA schedule before budgeting because categories and fees can change.
The regulatory classification and approved manufacturing arrangements should be confirmed before work is scoped.
GMP and the Manufacturing Licence
Any facility packing a complementary medicine in Australia must hold the licence or clearance applicable to its manufacturing step, product category and dosage form. A facility approved for one dose form is not automatically approved for another.
The TGA uses a risk-based approach to inspection frequency. Product and process risk, the manufacturer's compliance history and other risk factors affect when and how a site is inspected. Unannounced inspections may also be used.
Before choosing a facility, ask for its licence or clearance details, confirm the authorised scope and retain the evidence with the approved manufacturing arrangement.
TGO 92: What Must Appear on the Label
Therapeutic Goods Order No. 92 (TGO 92) is the mandatory standard for labels on non-prescription medicines, including all complementary medicines. It came into full force in July 2023 and replaced the older TGO 69. Every nutraceutical packed for the Australian market must comply with TGO 92, regardless of where the product is manufactured.
A compliant TGO 92 label includes:
- Active ingredient name and quantity per dosage unit, in a prominent format on the front of the pack
- AUST L, AUST L(A) or AUST R number clearly displayed
- Sponsor name and Australian address of the entity holding the ARTG entry
- Batch number and expiry date in legible, indelible marking
- Storage conditions including temperature range
- Warnings and contraindications as required by the Required Advisory Statements for Medicine Labels (RASML)
- Net quantity in metric units
The rules also cover minimum font sizes (1.5mm for active ingredient information, 2mm for warnings on outer packs), contrast ratios and the placement of mandatory text blocks. Specialty assembly work for retail-ready presentations like multi-pack promotions or gift sets adds another layer, because the outer pack also has to carry compliant information when it is the unit sold to the consumer.
Label design errors are the single most common compliance failure during TGA inspection. A reliable co-packer will run a pre-production label proof against the TGO 92 checklist and flag issues before the print run, not after.
Tamper Evidence, Batch Records and Traceability
Tamper-evident packaging is mandatory for most oral nutraceuticals under TGO 92, and the standard accepted is AS 2828 or equivalent. Common tamper-evident solutions include induction-sealed liners under the bottle cap, shrink bands across the closure, blister packs with no separate access point, and sachet-style sealing for powders. Whichever method is chosen, it must be documented in the product's ARTG entry and the verification procedure must form part of the batch packing record.
Batch records under PIC/S GMP must capture, at minimum: the materials used (with their own batch and supplier traceability), the equipment used, the operators, the in-process checks and results, the start and finish times, the yield reconciliation, the deviation log if any, and the QA sign-off authorising release. These records have to be retained for the shelf life of the product plus one year, or five years from the date of release, whichever is longer.
The practical test of a co-packer's batch management is straightforward: ask them to retrieve the full packing record for an arbitrary batch from twelve months ago. If it takes more than a working day, their record system is paper-heavy and a recall would be slow. Modern co-packers run digital batch records, with materials, counts and quality checks logged at the workstation in real time. CleverPak Connect captures this digitally as standard, so a recall trace runs in minutes rather than hours.
Indicative Costs and Timelines
Pricing for nutraceuticals contract packing in Australia varies with dose form, batch size, primary pack format and the level of compliance labeling required. The figures below are typical commercial ranges seen across the Australian market in 2026 for Listed complementary medicines packed under GMP. They are indicative, not quotes.
| Format | Typical batch size | Indicative piece rate (AUD) | Lead time |
|---|---|---|---|
| Tablets, HDPE bottle with induction seal, 60 count | 5,000 to 50,000 units | $0.55 to $1.20 per bottle | 3 to 5 weeks from approved brief |
| Capsules, blister pack 30 count, in carton | 10,000 to 100,000 units | $0.65 to $1.40 per pack | 4 to 6 weeks |
| Powder, single-dose sachet | 20,000 to 200,000 sachets | $0.18 to $0.42 per sachet | 3 to 5 weeks |
| Powder, tub with scoop and induction seal | 2,000 to 20,000 tubs | $0.95 to $2.20 per tub | 3 to 5 weeks |
| Liquid, oral dropper bottle 30ml with tamper band | 5,000 to 50,000 bottles | $0.85 to $1.80 per bottle | 4 to 6 weeks |
| Soft gel, blister pack 60 count, in carton | 10,000 to 100,000 units | $0.75 to $1.55 per pack | 4 to 6 weeks |
| Retail-ready promotional kit (gift pack with 2-3 SKUs) | 1,000 to 10,000 kits | $2.50 to $6.00 per kit | 5 to 8 weeks |
Choosing a Nutraceuticals Co-Packer in Australia
Evaluating a co-packer for complementary medicines goes well beyond the per-unit rate. The wrong choice surfaces months later as a TGA inspection finding, a recall, or a retailer rejecting a delivery for non-compliant labels. Use this checklist before signing with any partner.
- Current TGA manufacturing licence covering the specific dose form (tablet, capsule, soft gel, powder, liquid, sachet)
- Verifiable PIC/S GMP audit history with dates of TGA inspections and outcomes available on request
- TGO 92 label review process before any print run, including font size, RASML warnings, batch and expiry placement
- AS 2828-compliant tamper evidence applied at the primary pack, with verification documented in the batch record
- Digital batch records with materials, in-process checks and QA release traceable on demand, not paper-only systems
- Allergen and cross-contamination controls including documented changeover procedures between products containing peanuts, tree nuts, milk, soy, gluten, fish or shellfish-derived ingredients
- Retail-ready packing capability for Australian supermarket and pharmacy compliance, including barcode and shelf-ready carton requirements
- Cold chain or controlled-temperature handling if your product contains probiotics, fish oils or other heat-sensitive actives
- Recall procedure tested in the past 12 months with documented results and timing
- Insurance covering product liability and recall costs at appropriate limits, with a current certificate of currency available
- Reference customers in the supplements category willing to confirm consistency, communication and on-time delivery
Why Multi-Site Capacity Matters for Supplements
A network can provide resilience, but it does not make facilities interchangeable from a regulatory perspective. Every manufacturing step must be assigned to a manufacturer with the applicable licence or clearance. The authorised scope must cover the required manufacturing step, product category and dosage form.
CleverPak coordinates production through specialist facilities. For therapeutic-goods work, the proposed facility must demonstrate the licence or clearance applicable to the required manufacturing steps, product category and dosage form. These requirements are confirmed during scoping before a job is placed.
Frequently Asked Questions
Do I need a TGA-licensed co-packer if my supplement is sold online and not in pharmacies?
Yes. The TGA regulates the product, not the channel. Any complementary medicine sold to Australian consumers, including via direct-to-consumer e-commerce, must be on the ARTG and packed in a TGA-licensed facility under PIC/S GMP. Online-only sponsors discover this when their product is reported to the TGA, typically by a competitor, and the resulting compliance review is materially harder than getting the licensing right at the start.
Can my product be packed in a HACCP-certified food facility instead of a GMP facility?
Not lawfully, if the product is on the ARTG. HACCP and PIC/S GMP are different frameworks built for different risk profiles. A facility may hold both, and many CleverPak food-grade sites do, but the dose form and product category determine which licence applies. A protein powder sold as a sports food regulated by FSANZ can be HACCP-packed. The same product making a therapeutic claim becomes a Listed medicine and requires GMP. Check your ARTG entry, not the marketing positioning.
How long does it take to onboard a new nutraceuticals product with a contract packer?
Three to six weeks is realistic for a Listed complementary medicine with an existing ARTG entry, assuming labels are TGO 92 compliant, materials are available and the facility has prior experience with the dose form. New ARTG submissions, label redesigns or sites needing change-control to add the product to their licence schedule can extend onboarding to eight to twelve weeks. The accelerator most brands miss is providing the facility with the full ARTG entry, the label artwork and the master formula at first contact, rather than over five staggered emails.
What happens if a batch fails QA after packing?
PIC/S GMP requires a written deviation procedure. The QA team investigates the failure, decides whether the batch can be reworked, released under concession with the sponsor's agreement, quarantined for further investigation, or destroyed. The sponsor is notified, the deviation is logged, and any root cause action is documented under the facility's CAPA system. Reputable co-packers do not silently scrap or release questionable batches. Ask your prospective partner how many deviations they logged in the last twelve months and how the typical one resolved. A site claiming zero deviations is either very small or not telling the truth.
Do I need to be the sponsor on the ARTG, or can my contract packer hold the entry?
The sponsor is the legal entity that imports, exports or supplies the medicine in Australia, and is the entity responsible for compliance. In almost all cases the brand owner is the sponsor, not the co-packer. The co-packer is the manufacturer, listed on the ARTG entry under the sponsor's manufacturing arrangements. Some service providers offer a sponsor-of-record arrangement for offshore brands without an Australian entity, but the commercial and regulatory implications need legal review before agreeing to it. CleverPak operates as the manufacturer, not the sponsor, on the ARTG entries it packs against.
How does Australian nutraceuticals regulation compare with the US (FDA) and the UK (MHRA)?
The frameworks differ meaningfully. In the US, supplements fall under the FDA's Dietary Supplement Health and Education Act and 21 CFR Part 111 GMP, with a notification rather than pre-approval model and no equivalent of the ARTG. In the UK, supplements sit between food and medicines law, with the MHRA regulating any product making a medicinal claim and the Food Standards Agency covering the rest. Australia's TGA model with mandatory ARTG listing for almost all supplements is stricter than the US baseline and more centralised than the UK. Brands manufacturing in Australia for export commonly find the AU compliance bar already covers most US and UK requirements, but country-specific labeling has to be redone regardless. See our broader guide to contract packing in Australia for cross-market context.
What insurance should a nutraceuticals co-packer carry?
Public liability of at least AUD $20 million and product liability of at least AUD $10 million is standard for established Australian co-packers handling complementary medicines, with higher limits often required by enterprise customers. Recall coverage is increasingly written as an extension on the product liability policy rather than a separate cover. Ask for the certificate of currency, confirm the cover explicitly includes complementary medicines and verify the renewal date. Coverage that lapses mid-contract is a real and frequent problem in the smaller end of the market.