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Last updated: October 2026. We review this page quarterly.

Thai GACP Cannabis Flower as Starting Material for GMP Manufacture in Australia

Elite Organic Global is a medical cannabis producer in Thailand, with EU-GACP certified cultivation at our Sabai Sabai Farm site in Chanthaburi. This page explains how Australian rules treat imported cannabis flower that is used as starting material by an Australian GMP manufacturer. It is based on the published TGO 93, TGA guidance and Office of Drug Control (ODC) guidance, which are linked at the end of the page. It is written for Australian licensed manufacturers and importers looking at a non-Australian origin. It is general information, not legal advice.

Two different things can be imported

Australian rules separate two kinds of imported medicinal cannabis, and the difference decides whether a Thai GACP producer can take part at all.

A finished medicinal cannabis product. Under section 13 of TGO 93 (the Therapeutic Goods (Standard for Medicinal Cannabis) Order 2017), every manufacturing step that happens outside Australia must follow one of the GMP codes listed in subsection 13(2), such as the PIC/S Guide to GMP. Under subsection 13(3), the Australian sponsor must hold evidence of that GMP compliance. For a product made in a country other than those named in the Order (the UK, EU member states, Canada, South Africa, Israel and New Zealand), that evidence is written confirmation from the TGA that the site operates to the PIC/S Guide to GMP. In practice, this means a TGA inspection. These rules apply to products released for supply on or after 1 July 2023.

Starting material. Under subsection 13(1), the GMP requirement does not apply to plant material, or to oil extracted directly from the cannabis plant, when it is used as starting material to make another medicinal cannabis product. That other product must be made under subsections 13(2) and (3), or under a manufacturing licence issued by the TGA under Part 3-3 of the Therapeutic Goods Act.

The TGA's own FAQ says the same thing in practical terms. If imported flower is used as starting material at a site with GMP approval, the site where the plant is processed and the flower is dried does not need GMP approval. The manufacturing steps after the first drying are typically carried out at a TGA-licensed site in Australia, or at an overseas site with acceptable GMP evidence.

So the realistic route for flower from a Thai GACP site is as starting material for an Australian TGA-licensed manufacturer. Thai GACP flower cannot be imported as a finished product unless the Thai site itself has GMP confirmed by the TGA.

Who holds what on the Australian side

None of the following is something an overseas producer can hold or arrange:

  • A TGA manufacturing licence for the site that turns the flower into a finished product. The TGA treats storage of bulk dried flower as a manufacturing step. Flower from a site without GMP evidence may only go to a storage facility and then to a TGA-licensed manufacturer.
  • ODC import authorisation. Importing medicinal cannabis requires an ODC import licence and a separate import permit for each consignment, under regulation 5 of the Customs (Prohibited Imports) Regulations 1956. The ODC permit application asks for the purpose of the import, and one of the listed purposes is manufacture.
  • ODC licensing for manufacture under the Narcotic Drugs Act 1967. This is separate from the TGA licence.
  • Sponsor obligations, including holding GMP evidence for the finished product and making sure it complies with TGO 93.

The Thai side follows the same order as for other markets. Thailand issues export permission for a shipment against the buyer's import permit, so the Australian permit has to exist first.

What TGO 93 requires of the plant material

TGO 93 applies to finished products and also to the ingredients used to make them, including the cannabis plant (section 6). The parts that matter most for imported flower are listed below.

Schedule 1 tests (section 12). These limits apply on a dried basis, except for foreign matter, and use the stated European Pharmacopoeia methods:

  • Aflatoxins (Ph. Eur. 2.8.18): aflatoxin B1 not more than 2 µg/kg; B1, B2, G1 and G2 combined not more than 4 µg/kg
  • Foreign matter (Ph. Eur. 2.8.2): not more than 2.0%
  • Heavy metals (Ph. Eur. 2.4.27): arsenic not more than 3.0 mg/kg, cadmium not more than 0.5 mg/kg, lead not more than 5.0 mg/kg, mercury not more than 0.5 mg/kg
  • Ochratoxin A (Ph. Eur. 2.8.22): not more than 20 µg/kg
  • Pesticides (Ph. Eur. 2.8.13): not more than the limits in that method
  • Total ash (Ph. Eur. 2.4.16): not more than 20.0%

Identification (section 10). The plant material must be positively identified by macroscopic examination, microscopic examination and chromatographic procedures.

Decontamination (section 9). Any decontaminating treatment must not harm product quality and must not use ethylene oxide.

Monograph (section 7). The Ph. Eur. monograph Pharmaceutical Preparations (2619) applies. This brings in related monographs such as Herbal Drugs (1433).

Microbiology (section 16). Since the 2022 amendments, TGO 93 itself sets microbiological acceptance criteria for products in oral dosage form or for inhalation, by reference to the BP, Ph. Eur. or USP. Strictly, this applies to the finished product. In practice, the manufacturer's incoming specification for flower is built so that the finished product will pass.

Irradiation is a contract term

Many importers treat imported flower to control microbial counts. TGO 93 allows decontamination as long as it does not harm quality and does not use ethylene oxide. That makes irradiation a commercial and specification decision. It should be written into the supply agreement:

  • whether treatment is required for the intended product;
  • who carries it out, and at which licensed site;
  • who pays for it;
  • which specification applies after treatment.

We do not irradiate, because irradiation measurably reduces terpene content.

Where testing happens, and who controls it

The Australian manufacturer tests in Australia, in laboratories the exporter does not control. That is normal and manageable if three things are agreed in advance:

  1. A named list of laboratories, accredited to ISO/IEC 17025 and acceptable to both sides.
  2. Split samples. The producer keeps a sealed counter-sample from the same batch.
  3. A referee procedure. If results disagree, an agreed third laboratory decides, and the contract says who pays in each outcome.

What an Australian manufacturer will ask a Thai supplier for

  • GACP certification for the cultivation site, with the holder, scope and validity dates;
  • results against each Schedule 1 parameter, with the methods stated;
  • the identification data required by section 10;
  • the supplier's position on irradiation and decontamination, in writing;
  • confirmation that the material is supplied as starting material, and the name of the TGA-licensed site where GMP manufacture will take place.

Our position

EU-GACP: our Sabai Sabai Farm site in Chanthaburi holds a Control Union GAP & GACP declaration to the WHO and EMA guidelines (valid to September 2027). It also holds Thai DTAM Cannabis GACP certification (TH-GACP 87/2568, 4,104 m², valid to September 2028).

We are a cultivation and post-harvest producer, not a GMP manufacturer, and we hold no Australian licences. In an Australian arrangement, GMP manufacture, the TGA licence and ODC authorisations all sit with the Australian partner. Our samples have been tested against TGO 93 parameters in Australia.

We run fifteen flowering rooms. Our flower is hand-trimmed and not irradiated.

For supply discussions: [email protected]

Sources

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