Medicinal cannabis reforms: Frequently asked questions

TGO 93 applies to all medicinal cannabis products, both ingredients and finished product, supplied in Australia.

No. Medicinal cannabis products imported or manufactured for supply in Australia must comply with TGO 93.

There are offence provisions in the Therapeutic Goods Act 1989 (the Act) for the import, export and supply of medicines not complying with a relevant standard, in this instance TGO 93, and these provisions apply to everyone in the supply chain, not just the importer or sponsor.

Where there are any differences between TGO 93 and the European Pharmacopeia cannabis flower monograph (3028) (Ph Eur 3028), TGO 93 applies.

We have performed a gap analysis, and the differences are limited to:

• stated content
• limits for the determination of foreign matter
• limits for heavy metals
• requirement for loss on drying
• labels.

TGO 93 was published before the Ph Eur 3028 monograph came into effect. TGO 93 will be reviewed and amended as necessary in light of the new monograph.

Manufacturers operating under Good Manufacturing Principles (GMP) are required under the PIC/S Guide to GMP to establish appropriately validated stability studies for their medicinal cannabis products to support their shelf life.

For a sponsor to hold medicinal cannabis products under their 'direct control', they must:

• maintain legal ownership of the product, and
• make decisions as to where and how the products are to be kept, and to whom (i.e. the Authorised Prescriber (AP) or the Special Access Scheme (SAS) approval holder) the products are to be supplied.

A sponsor of finished medicinal cannabis products will not meet the 'direct control' requirement if:

• the legal ownership of the products is transferred to a person other than the sponsor prior to the supply of those products, 
• the sponsor doesn’t decide where the products are to be kept, and when and to whom the products are supplied, prior to the supply of those products (i.e. the sponsor is the decision maker in relation to supply of the product on the basis of an AP or SAS approval), or
• the distributor providing storage or warehousing services for medicinal cannabis products does not store the products in a separate locked area where access is restricted to the sponsor and the distributor only.

No. If a sponsor supplies medicinal cannabis products to a distributor for them to sell to a pharmacist, the sponsor has not met the ‘direct control’ requirements.

Distributors may provide warehousing, brokerage and courier services to sponsors, but the sponsor must retain ownership and direct control of the medicinal cannabis product.

No. If goods from multiple sponsors are stored together, each sponsor has not met the direct control requirements.

No. Most medicinal cannabis products are being supplied in Australia as unregistered goods. The Therapeutic Goods Regulations 1990 exempt medicinal cannabis products, that have been imported or manufactured in Australia, from the requirement to be entered on the Australian Register of Therapeutic Goods (ARTG), provided the medicinal cannabis products are held under the direct control of the sponsor until they are supplied under one of the approved pathways (SAS, AP or an approved clinical trial only).

The supply of medicinal cannabis products, that are not on the ARTG, through wholesale arrangements is prohibited. This is because wholesale arrangements generally involve the sale of the products to an intermediary or third party, which means that the products are no longer under the sponsor's direct control.

The direct control requirements for medicinal cannabis products that have been imported or manufactured in Australia do not apply to starting materials, such as bulk dried flower.

Starting material may be supplied via wholesale. The wholesaler must be aware of the current GMP evidence requirements under TGO 93 and the requirements of Item 2 of Schedule 7 to the Regulations when on-selling. If the starting material has come from a site without GMP evidence or holding a TGA licence, it may only go to a storage facility and be sold to a TGA licensed manufacturing site.

While there are no restrictions under the Therapeutic Goods Act 1989 that prohibit the supply of starting material via wholesale arrangements there may be restrictions under the Narcotic Drugs Act 1967, the Customs (Prohibited Imports) Regulations 1956 or state and territory legislation.

TGO 93 does not place restrictions on the country of origin of medicinal cannabis products.

Overseas manufacturing of medicinal cannabis must occur at sites that comply with one of the Good Manufacturing Practice (GMP) standards in subsection 13(2) of TGO 93, and the Australian sponsor (the importer) of the medicinal cannabis product must hold evidence of GMP compliance in accordance with subsection 13(3) of TGO 93.

We will accept proof of GMP issued by authorities in the following countries – the United Kingdom, members of the European Union, Israel, South Africa, New Zealand and Canada.

For medicinal cannabis that has been manufactured in any other country, a GMP inspection by the TGA will be required.

TGO 93 does not apply to export-only finished products. Australian manufacturers can continue to export raw materials in compliance with TGO 93 and in accordance with existing licensing requirements, practices and procedures.

The steps of manufacture that require GMP approval from a regulatory agency are the same for both domestically manufactured and imported medicinal cannabis products. This means, a TGA licensed site or an approval from an agency listed in subsection 13(3) of TGO 93.

The manufacturing steps that require GMP approval may include:

• any processing steps performed after the first crude extraction
• packaging
• labelling
• storage
• sterilising/decontamination e.g., irradiation 
• testing
• release for supply.

For further information see our Technical guidance on the interpretation of the PIC/S Guide to GMP and Annex 7(pdf,1.2Mb)

Schedule 7 to the Therapeutic Goods Regulations 1990 identifies certain goods that can be manufactured in Australia without GMP. These include manufacture of most excipient ingredients and plant material/oil (under certain conditions). Subsection 13(1) of TGO 93 applies the same exemption for plant material and oil for overseas manufacturing.

These exemptions apply when cannabis plant material is used as a starting material for further manufacture at a TGA licensed manufacturer or an overseas manufacturing site that has GMP evidence as listed in subsection 13(3) of TGO 93. These exemptions allow cultivation sites to grow, cut and dry cannabis plant material, or perform the first crude extraction step where the material is used for further manufacture at a GMP licensed site without themselves holding a GMP approval from a regulatory agency.

The precise stage from which GMP is required depends on a number of factors.

If the imported flower is to be used as a starting material at a site that has GMP approval, the site where the cannabis plant is processed and the flowers are dried does not require GMP approval. Typically, the manufacturing steps that occur after the initial drying of cannabis flower or the initial cannabis crude extract must be undertaken at either a TGA licensed manufacturing site in Australia or an overseas manufacturing site that has GMP evidence as listed in subsection 13(3) of TGO 93.

The site manufacturing the finished good must ensure that all quality requirements applicable to the starting material (in this case, flowers) are met, as part of their GMP obligations and to ensure the finished product is of appropriate quality.

Yes. Processes to decontaminate the cannabis plant to reduce the microbial load are critical to the safety of medicinal cannabis products Any decontamination treatment, such as irradiation, must be conducted under GMP at either a TGA licensed manufacturing site in Australia or an overseas site that has GMP evidence as listed in subsection 13(3) of TGO93.

TGO 93 does not specify a particular decontamination method. Any treatment must not:

• adversely affect the quality of the medicinal cannabis product, or
• make use, or otherwise contain ethylene oxide.

It is the sponsor's responsibility for ensuring their medicinal cannabis product complies with the microbial limits set out in TGO 93.

Regardless of whether the plant material or oil comes from an overseas or Australian site:

• there may be an exemption from a requirement to hold GMP
• the medicinal cannabis plant material or oil must meet TGO 93 requirements when supplied in Australia.

The Australian finished goods manufacturer must only accept materials of appropriate quality, to ensure that the finished goods themselves meet all quality and regulatory requirements.

For example, the finished goods manufacturer is likely to only accept batches of starting material that meet desired levels of specified cannabinoids. Similarly, it would place requirements on accurate identification of the plant material and acceptable microbiological attributes, in line with TGO 93 requirements.

A valid GMP certificate from an EU member state is only acceptable GMP evidence for medicinal cannabis manufactured in that or any other EU member state (section 13(3)(b) of TGO 93).

The only exception for this is product manufactured in Canada where the requirements of 13(3)(c)(i)(A) apply.

A site in any other country outside the European Union will be considered under section 13(3)(f), even if they hold an EU GMP Certificate, and therefore requires written confirmation from the TGA as GMP evidence.

No. Different jurisdictions have different regulations for cannabis products.  In Australia, cannabis products can only be supplied to patients as a therapeutic good i.e., a medicinal cannabis product.  Other countries may be manufacturing cannabis for recreational use.

All medicinal cannabis products supplied to Australian patients – finished products imported from overseas, imported materials that undergo further manufacturing in Australia and products grown and fully manufactured within Australia – must comply with TGO 93.

To supply a cannabis product imported from a country listed in TGO 93 into Australia you must hold GMP evidence that complies with subsection 13(3) of TGO 93.

Yes. Storage is a step in manufacture and the site storing the bulk dried flower must have a TGA licence.

No. The manufacturing requirements for overseas manufacturers in TGO 93 came into force on 1 July 2023 resulting in equivalent GMP requirements for all medicinal cannabis products supplied in Australia, regardless of place of manufacture.

No. The requirement to comply with TGO 93 is now in force and sponsors are responsible for ensuring that all sites in the supply chain have the required evidence of compliance with GMP specified in TGO 93.

Manufacturers operating under Good Manufacturing Principles are required under the PIC/S Guide to GMP to have appropriate procedures in place to record, assess, investigate and review complaints. Suppliers should work with the manufacturer and sponsor of medicinal cannabis products to resolve the complaint.

If the complaint is related to defects that you think may have arisen during manufacture, storage or handling of a medicine you can submit a report via our website.

If the complaint is related to a perceived breach, counterfeit products, or questionable practices, submit a report via our website or email us at GMPCompliance@health.gov.au.

'Release for supply' (RFS) is the final step of manufacture of a medicine and is defined as the certification by an authorised person 'that each production batch has been produced and controlled in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of medicinal products’.

The RFS for medicinal cannabis products must be performed at either a TGA licensed manufacturing site in Australia or an overseas manufacturing site that has GMP evidence as listed in subsection 13(3) of TGO93.

'Release for supply' (RFS) is the final step of manufacture of a medicine and is defined as the certification by an authorised person 'that each production batch has been produced and controlled in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of medicinal products’.

The manufacturer performing release for supply takes responsibility for ensuring that each batch of finished product meets all quality specifications and complies with regulatory requirements.

Release for supply is a manufacturing step that requires a TGA licence. If a company wants to perform release for supply they must:

• hold a TGA manufacturing licence,
• be authorised for that step in manufacture,
• the release for supply step must be undertaken by an Authorised person, and 
• the Authorised Person confirm that each batch of medicinal cannabis products comply with the requirements in TGO 93.

The TGA will inspect in accordance with the Australian standard of GMP in force at the time of the inspection. The end result will be written confirmation or certificate of GMP compliance issued by the TGA. Further information is available on the TGA website including a Step-by-step guide to Australian manufacturing licences and overseas GMP certification.

No. TGA GMP clearances are only issued for medicines to be entered on the Australian Register of Therapeutic Goods. GMP clearances are not issued for medicinal cannabis products supplied under the Special Access (SAS) or Authorised Prescriber (AP) schemes.

The TGA will take the same approach to GMP inspections as it currently follows when inspecting any other manufacturing site.

The nature of the inspection will depend on the circumstances and the agreed scope and cost. If multiple medicinal cannabis products are produced in a facility, an inspection may be able to cover all of the medicinal cannabis products that are or will be imported from that facility.

Further information on TGA GMP inspections is available on the TGA website.

The cost of an inspection will vary depending on location, product type, site characteristics and other variables. A summary of TGA fees and charges is available on our website.

GMP certificates from a country listed in section 13 of TGO 93 will be accepted, even if that country does not have a Mutual Recognition Agreement (MRA) with Australia.

If a country is not referred to in section 13 of TGO 93, an inspection by the TGA will be required.

Yes.

The principle behind the labelling requirements is that patients should understand what the goods are and how to use them safely. In cases where it is physically impossible to include all details on the bottle itself, the TGA would expect a sponsor to take a pragmatic approach, ensuring that the information is provided to the patient in some form (e.g. outer cartons and/or information leaflets).

A manufacturer of medicinal cannabis may extend the expiry date, where the ongoing stability studies show that the finished product remains compliant with the release specifications throughout the new shelf-life.

If a medicinal cannabis product expiry date is extended, a new label needs to be applied to the finished product. Labelling is a step in manufacture and must be conducted at a TGA licensed site, or an overseas site that complies with the requirements in Section 13 (3) of TGO 93.

If the medicinal cannabis product has been distributed when the expiry date has been extended, the product must be recalled and relabelled with the new expiry date.

Note, the Australian Quality use of medicines guidelines and the National Medicines Policy require appropriate labelling and information on the expiry of medicines provided to patients. Pharmacists should not sell medicinal cannabis products that have expired.

No. Section 15 (2) (e) of TGO 93 specifies the expiry date must be on the label.

No. Section 4 of TGO 93 explains that the expiry date prefix cannot be in the form of best before or best by or words to that effect.

SAS/AP approvals are not relevant to supply of ingredients or starting materials. Starting material can be supplied to compounding pharmacists, in line with state and territory requirements. Additional information is available from the Pharmacy Board of Australia as well as State or Territory Health Departments. Until there is a specific patient, there would not be any SAS/AP documentation.

If finished goods are supplied to a compounding pharmacy, for example tablets that will be crushed and made into an oral liquid, those goods must be supplied under a SAS/AP approval.

The compounding pharmacists cannot compound a medicinal cannabis product from the starting material until they have received a prescription for a specific patient that meets the SAS/AP requirements.

No. Extemporaneously compounded medicinal cannabis products need to be compounded by a pharmacist, for a particular person at a particular time and in response to a specific prescription. Under the current rules, products cannot be legally compounded in advance or in anticipation of patients materialising with a relevant prescription.

A pharmacy can deal with a large number of orders, but they must each be made for a particular patient and particular prescription.

There is no aggregate limit that a company can supply in a particular period. However, pharmacists can only compound a product for a specific patient when a prescription that meets the SAS/AP requirements has been presented.

No. The pharmacist must comply with existing procedures for prescriptions that are provided under the SAS/AP pathways.

Yes. Medicinal cannabis products can still be compounded for approved clinical trials.

Imported dried flower that is that is exempt from GMP requirements under subsection 13(1) of TGO 93 cannot be supplied directly to an unlicensed compounding pharmacy.

Imported dried flower that has GMP evidence that complies with subsection 13(3) of TGO 93 can be supplied directly to an unlicensed compounding pharmacy.

The critical difference between imported dried flower that is exempt from GMP requirements and imported dried flower that has GMP evidence is the ‘release for supply’ (or release for further processing) manufacturing step performed at either a TGA licensed site in Australia (after importation) or at an overseas manufacturing site compliant with section 13 of TGO 93. This means, bulk dried flower from a site without GMP cannot be directly supplied to an Australian compounding site that does not have a GMP licence.

Compounders are reminded, regardless of the GMP status of the supplier of their medicinal cannabis products, that they need to ensure their ‘finished’ compounded product will meet the quality requirements of TGO 93. For example, heavy metals contamination, pesticide levels, microbial limits.

Yes. A compounding pharmacist is not exempt from meeting the quality standards that apply to the therapeutic products they manufacture, for medicinal cannabis products this is TGO 93.

There are offence provisions in the Therapeutic Goods Act 1989 (the Act) for import and supply of medicines not complying with a relevant standard, in this instance TGO 93, and these provisions apply to everyone in the supply chain, not just the importer or sponsor. When medicinal cannabis is prescribed and supplied under the Special Access Scheme (SAS) or Authorised Prescriber (AP) pathways, both the prescriber and dispenser take on responsibility for providing patients with medicines that are effective, safe and of good quality. This is because the medicines have not been evaluated by the TGA.

Imported dried flower that is that is exempt from GMP requirements under subsection 13(1) of TGO 93 cannot be supplied directly to an unlicensed compounding pharmacy.

Imported dried flower that has GMP evidence that complies with subsection 13(3) of TGO 93 can be supplied directly to an unlicensed compounding pharmacy.

The critical difference between imported dried flower that is exempt from GMP requirements and imported dried flower that has GMP evidence is the ‘release for supply’ (or release for further processing) manufacturing step performed at either a TGA licensed site in Australia (after importation) or at an overseas manufacturing site compliant with section 13 of TGO 93. This means, bulk dried flower from a site without GMP cannot be directly supplied to an Australian compounding site that does not have a GMP licence.

Compounders are reminded, regardless of the GMP status of the supplier of their medicinal cannabis products, that they need to ensure their ‘finished’ compounded product will meet the quality requirements of TGO 93. For example, heavy metals contamination, pesticide levels, microbial limits.

No. TGO 93 does not allow a synthetically manufactured CBD product to be supplied as a medicinal cannabis product.

The current entry for CBD in Schedule 3 to the Poisons Standard includes synthetic and naturally derived CBD. In the event a synthetic CBD based medicine is registered on the ARTG as an OTC medicine, the TGA expects that TGO 93 will be amended accordingly.

The pharmacy or sponsor should return the product to the supplier or appropriately dispose of it using normal pharmaceutical disposal procedures.

Under no circumstances should any synthetic delta-8 product be supplied to Australian patients.

TGO 93 applies to any medicinal cannabis product that is made in whole or part from the cannabis plant, noting that it prohibits cannabis that has undergone chemical transformation.

If the 'synthetic CBD' is wholly synthetic (i.e. is not made from the cannabis plant in any way), then it is not 'medicinal cannabis' and therefore TGO 93 does not apply.

Yes. Section 8(b) of TGO 93 makes clear that medicinal cannabis products will not comply with the standard if the active ingredient has been modified or transformed 'in any way (including by chemical or other means)'.