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Medicinal cannabis reforms: Frequently asked questions
In recent years, there has been a significant increase in the supply and use of medicinal cannabis products in Australia. In light of this, the TGA undertook a review of the regulation of these medicines to ensure it was still fit for purpose. This review included a public consultation held between December 2020 and January 2021. The changes implemented take into account feedback received during the consultation.
The reforms will benefit both the industry and patients, through:
- Enhanced ability for patients and medicinal practitioners to identify equivalent products within the large range available. This will be achieved by requiring more information on product labels.
- Greater certainty to Australian patients and medical practitioners around quality and safety by ensuring that both Australian and overseas medicinal cannabis manufacturers operate under equivalent manufacturing standards.
- Clarity for sponsors and manufacturers operating in multiple jurisdictions as to the minimum safety and quality requirements in Australia.
- Greater regulatory oversight of extemporaneous compounding of medicinal cannabis products by medical practitioners and pharmacists.
TGO 93 does not place restrictions on the country of origin of medicinal cannabis products. Regardless of country of origin, all imported medicinal cannabis products released for supply from 1 July 2023 must be manufactured in accordance with one of the identified Good Manufacturing Practice (GMP) standards.
The TGA will accept proof of GMP issued by authorities in certain countries, including the United Kingdom, members of the European Union, Israel, South Africa and Canada. For other countries, a GMP inspection by the TGA may be required.
TGO 93 does not apply to export-only products. Australian manufacturers can continue to export raw materials in accordance with existing licensing requirements, practices and procedures.
The steps of manufacture that require GMP compliance are the same for both domestically manufactured and imported medicinal cannabis products.
For further information about this, see the TGA's Technical guidance on the interpretation of the PIC/S Guide to GMP and Annex 7 ('Manufacture of Herbal Medicinal Products') of the PIC/S Guide to GMP.
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.
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, it is the processes that occur after drying of cannabis flower or the initial extraction of the bulk cannabis oil that must be undertaken in an appropriately licensed or approved GMP facility.
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.
Irradiation of any medicinal cannabis material must be conducted under GMP at a suitably licensed or approved site.
Regardless of whether the bulk dried flower comes from a site with its own GMP approval or without, the manufacturer of finished products must ensure that ingredients used in the formulation meet all applicable quality requirements. This could be demonstrated by testing undertaken by the manufacturer or vendor qualification processes (which could reduce in-house testing requirements).
The 'further processing' could range from packaging and labelling of the bulk flower into patient-ready pack sizes as the finished dosage form, with associated quality control processes, to more complex processing.
Regardless of type of 'further processing', the manufacturer performing release for supply takes responsibility for ensuring that each batch of medicine meets all quality specifications and complies with regulatory requirements.
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. There is no mechanism within the Therapeutic Goods Act 1989 to provide exemptions to the requirements of TGO 93. The transition arrangements gave the necessary time for manufacturers and sponsors to implement the new GMP requirements and update their supply chain if required.
Yes, but only if the release for supply date for the manufactured batch was prior to 1 July 2023. It is expected that this would only be required in limited circumstances, for example where unforeseen delays affect shipping. Sponsors and manufacturers should have planned for the implementation of the new requirements and made the necessary changes to their supply chains.
After 1 July 2023, imported bulk dried flower that is exempt from GMP requirements under section 13 of TGO 93 cannot be supplied directly to an unlicensed compounding pharmacy.
From 1 July 2023, the supply chain must include a release for supply (or release for further processing) manufacturing step performed at either a TGA GMP licensed site in Australia (after importation) or at an overseas manufacturing site compliant with section 13 of TGO 93. So bulk 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 must also meet the requirements of sections 12 and 16 of TGO 93.
Evidence, records and inspections
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.
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.
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.
The requirements set out in TGO 93 were developed following extensive consultation.
Unlike some jurisdictions, Australia regulates medicinal cannabis products as medicines and, accordingly, GMP compliance is required. These changes extend to imported products similar requirements to those already imposed on Australian manufactured products.
Labelling and packaging requirements
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).
Yes. The TGA encourages manufacturers to update packaging as part of its normal business cycle so that all labels are compliant by 1 July 2023.
Oral-dosage form is a commonly used term, which at its highest means a product intended for oral use. For example, a solid dosage form includes capsules and tablets.
Dried flower may be an oral dosage form if the final product (i.e. patient ready pack) is presented in such a way that it is clearly intended for oral consumption.
The intention of TGO 93 section 14 is for child resistant closures to be required in the same circumstances as products referred to in TGO 95. Consequently, topical creams typically do not require child resistant closures. As we have received a number of queries regarding this, minor amendments to section 14 will be made to make this clear.
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.
Continued prohibition on synthetic cannabis
No. TGO 93, both before and after the March 2022 changes, 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)'.
Understanding the new rules
Yes. TGO 93 applies to all medicinal cannabis products, both ingredients and finished product, supplied in Australia.
Starting materials are those materials that are used to make up the finished product. This includes APIs (i.e. Active Pharmaceutical Ingredients) such as dried flower (floss), oil, or purified oil), as well as non-APIs such as excipients, water used in manufacture, primary and secondary packaging materials and labels.
'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’. We have further details on release for supply.
For medicinal cannabis products, RFS must be performed at either a TGA licensed site in Australia or, from 1 July 2023, at an overseas site that has approvals that comply with TGO 93.
If a particular batch is released for supply at an overseas site before 1 July 2023, the batch does not need to comply with section 13 of TGO 93.
Medicines manufactured at multiple sites
Medicinal cannabis products partially manufactured overseas may be 'released for further processing' (RFFP) by the authorised person at the overseas site and then imported into Australia for subsequent manufacturing by an Australian licensed manufacturer. In this scenario, RFS relies on decisions of other authorised persons in the manufacturing chain. Knowledge of appropriate GMP agreements between, and the Pharmaceutical Quality Systems (PQS) of, all parties is needed to support the RFS decision.
The TGA's expectation is that sponsors will be able to comply by 1 July 2023. However, the TGA will take a pragmatic approach should there be unreasonable delays in the TGA’s inspection timelines.