Exporting cannabis from Canada to Australia requires approvals from two national regulators, compliance with a specific manufacturing standard, and a supply chain built around documentation that Australian importers and pharmacies expect at every point of sale. For a Canadian Health Canada Licensed Producer, the pathway is real and well-travelled, but it has more moving parts than the German channel. This guide covers every step, from qualifying your facility through to first shipment.
Australia's medical cannabis framework sits across two federal bodies: the Therapeutic Goods Administration (TGA), which governs product registration and Special Access Scheme authorisations, and the Office of Drug Control (ODC), which handles import and export licences under the Narcotic Drugs Act 1967. You'll deal with both throughout the process, and so will your Australian importer. Building that importer relationship early is one of the most impactful steps you can take.
The regulatory framework: TGA, ODC, and Health Canada working in parallel
Three regulators govern a Canada-to-Australia cannabis shipment, and each one has a distinct role.
Health Canada authorises the export from the Canadian side. Your LP must already hold export authorisation under the Cannabis Act and the Cannabis Regulations. For each shipment, you apply for a per-shipment export permit, typically using the Health Canada online portal. The permit specifies the quantity, form, destination country, and receiving party. Processing takes five to ten business days in most cases.
The ODC administers import licences and per-shipment import permits for Australia. Your Australian partner needs an Import Licence from the ODC (an annual licence covering their facility) and a Narcotic Import Permit for each shipment. The ODC issues permits under the Narcotic Drugs Act 1967, cross-referenced with Australia's obligations under the Single Convention on Narcotic Drugs. Australia's ODC and Canada's Health Canada communicate on a government-to-government basis; the permits from each side need to align in quantity and timing.
The TGA governs whether the product can be legally supplied to patients in Australia. Most Canadian cannabis enters under the TGA Special Access Scheme (SAS) or the Authorised Prescriber pathway, both of which bypass full product registration. The importer or product sponsor manages SAS authorisations on their end. Your obligation is to ensure the product meets TGO 93 and that you can supply the documentation to support TGA product descriptions accurately.
TGO 93 compliance: what your COA needs to cover
TGO 93 is Australia's manufacturing standard for medicinal cannabis, and it sets out the minimum testing requirements that every batch supplied into the Australian channel must meet. If your Certificate of Analysis doesn't cover every required analyte, Australian importers won't accept the shipment.
TGO 93 required testing categories
- Cannabinoid potency: Total THC, Total CBD, and the key minor cannabinoids must be reported. TGO 93 specifies potency testing using a validated method; HPLC is the standard approach.
- Microbial contamination: Limits for total aerobic microbial count (TAMC), total combined yeast and mould count (TYMC), bile-tolerant gram-negative bacteria, and specified organisms (Salmonella, E. coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans).
- Heavy metals: Cadmium, lead, arsenic, and mercury, each with defined maximum limits.
- Pesticide residues: Compliance with the list of permitted pesticides, tested by an accredited laboratory.
- Mycotoxins: Aflatoxins B1, B2, G1, G2 and ochratoxin A.
- Foreign matter: Visual inspection for stems, seeds, and other physical contaminants.
Your testing laboratory must hold accreditation to ISO/IEC 17025, and test methods must be validated. Some Australian importers also request that the testing laboratory be based in Australia or have a recognised international accreditation body. Confirm this with your importer before finalising your COA format. Any gap between your standard COA panel and TGO 93's requirements will need to be filled before the first shipment, not after.
GMP requirements: does Health Canada GMP satisfy Australia?
Canada and Australia have a long-standing recognition arrangement for pharmaceutical GMP. Under bilateral agreements, the TGA accepts Health Canada GMP certificates as equivalent in most circumstances, which means a Canadian LP with a current Health Canada GMP compliance record can supply Australia without obtaining a separate EU-GMP certificate.
That said, the picture has some nuance worth understanding before you approach Australian importers.
Health Canada issues GMP compliance letters or Establishment Licences that serve as the primary GMP evidence for export. Your Establishment Licence must be current, and the licensed activities must cover the product you're exporting (for dried flower, this means cultivation and packaging, at minimum). Include your Establishment Licence in every importer due-diligence package.
Some Australian importers and product sponsors request EU-GMP certification in addition to Health Canada GMP, typically because they supply into multiple international markets simultaneously and prefer a single standard. If your target importer has that requirement, you'll need to factor the EU-GMP certification timeline (commonly 9-18 months for first certification) into your market entry plan.
Where GACP (Good Agricultural and Collection Practice) applies, Australian importers may ask for GACP documentation alongside GMP records. GACP covers cultivation practices at the primary production level and is referenced in EU guidelines for herbal starting materials. Having your indoor cultivation practices documented against GACP principles strengthens due diligence submissions even when GACP certification isn't a formal requirement.
The 5-step Canada-Australia supply pathway
Getting from a signed supply agreement to first shipment follows a defined sequence. Skipping steps or running them out of order is the most common cause of delays in the Australian channel.
Step 1: Qualify your facility and product
Confirm your Health Canada export authorisation is in place and covers dried flower exports. Verify your COA panels against TGO 93. Resolve any gaps in testing coverage before approaching importers. For a detailed walkthrough of what a compliant COA looks like from a buyer's perspective, see our guide to reading a cannabis Certificate of Analysis.
Step 2: Select and onboard an Australian importer
Your Australian importer must hold an ODC Import Licence. They must also understand the SAS or Authorised Prescriber pathway well enough to manage patient access authorisations on their end. Due diligence on your importer's ODC licence status and TGA experience is non-negotiable. This is the relationship that unlocks the market; vet it accordingly.
Step 3: Run parallel permit applications
Your importer applies to the ODC for a Narcotic Import Permit. You apply to Health Canada for an Export Permit under the Cannabis Regulations. Both applications should be submitted simultaneously, as each regulator will ask for reference to the counterpart permit. Typical combined timeline: 15-20 business days from submission to both permits issued.
Step 4: Prepare the shipment documentation package
A compliant shipment to Australia requires: COA (TGO 93-compliant panel, ISO/IEC 17025 accredited lab), Establishment Licence copy, Export Permit, Commercial Invoice (quantities in grams), packing list, Certificate of Origin, and a product specification sheet. Some importers also request a Safety Data Sheet and a batch summary report. Confirm the full documentation checklist with your importer before finalising. Our export packaging and labelling guide covers the label fields that Australian importers expect to see on the outer and inner packaging.
Step 5: Ship and clear customs
Cannabis exported to Australia requires both the ODC Import Permit and Health Canada Export Permit to be physically or electronically referenced at customs in both countries. Work with a freight forwarder experienced in Schedule 8 controlled substance shipments into Australia. Temperature-controlled shipping is not a regulatory requirement for dried flower, but maintaining consistent humidity during transit preserves product quality and reduces rejection risk on arrival.
AlphaLeaf is a Montreal-based Health Canada Licensed Producer of indoor-grown, hand-trimmed cannabis flower. Our Establishment Licence covers cultivation and packaging of dried flower for export, our batch COAs are produced by an ISO/IEC 17025 accredited laboratory with full TGO 93-compliant panels, and we hold export authorisation under the Cannabis Act. We work with Australian importers who supply the medical channel and can provide the full due-diligence documentation package on request. Contact our export team to discuss your supply requirements.
Frequently Asked Questions
Does Health Canada allow Canadian LPs to export cannabis to Australia?
Yes. Under the Cannabis Act and Cannabis Regulations, a Canadian Licensed Producer holding export authorisation can apply to Health Canada for a per-shipment export permit to Australia. Australia is a recognised legal market under the Single Convention on Narcotic Drugs, so the pathway is well-established.
What does TGO 93 require from a Canadian cannabis supplier?
The Therapeutic Goods Order No. 93 (TGO 93) sets out the standard for medicinal cannabis in Australia. It requires potency testing, microbial limits, heavy metal limits, pesticide residue limits, and mycotoxin limits, all verified by an accredited laboratory. Canadian LPs supplying Australia must ensure their COA panels cover every TGO 93 analyte and that test methods are validated.
Does a Canadian LP need EU-GMP to export to Australia?
Not always. Australia accepts Health Canada GMP as a recognised equivalent in many cases, particularly for finished dried flower. However, some Australian importers and product sponsors request EU-GMP documentation as a risk-management measure. Confirming the importer's requirements before committing to a GMP certification path is important.
How long does the ODC import permit process take?
The ODC typically processes import permit applications within 10-15 business days, though first-time applications or those involving a new Canadian supplier may take longer. Your Australian importer applies for the import permit; you apply to Health Canada for the corresponding export permit. Both must be in hand before the shipment leaves Canada.
What is a TGA Special Access Scheme authorisation, and which pathway does an importer need?
Most medical cannabis in Australia enters under the TGA Special Access Scheme (SAS) or the Authorised Prescriber (AP) pathway, rather than full product registration. SAS Category B allows medical practitioners to prescribe unapproved therapeutic goods for individual patients. Your importer or product sponsor manages SAS authorisations; your role is to supply a product that meets TGO 93 and can be described accurately on TGA documentation.
