If you're planning to supply unapproved medicinal cannabis in Australia, this is your starting point.
Before supplying medicinal cannabis, you must understand how this is regulated and your responsibilities under the access pathways.
You must ensure that an exemption, approval, or authority is obtained prior to supply.
Being well-prepared helps ensure lawful supply and avoids regulatory delays.
Start by reviewing your responsibilities and selecting the appropriate supply pathway.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all products.
General information
Learn about how products are regulated.
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PageAn overview of guidance for the use of medicinal cannabis in Australia.
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PageFind out how we regulate clinical trials in Australia and ensure compliance with Good Clinical Practice.
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PageDocuments and further information for prescribers of medicinal cannabis products.
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PageClinical guidance and information about access pathways for medicinal cannabis.
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PageInformation for importers, exporters and manufacturers of medicinal cannabis.
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GuidanceThis guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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PageLists to help prescribers and pharmacists in prescribing and supplying medicinal cannabis products under the SAS/AP categories.
Legislation, Acts and Orders
Review the laws and legal orders that regulate therapeutic goods.
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PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
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LegislationThis Specification facilitates the publication of aggregated and de-identified statistical information in relation to medicinal cannabis products under the authorised prescriber (AP), special access scheme category A (SAS A) and special access scheme category B (SAS B) pathways.
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LegislationThis Specification facilitates the publication of information about medicinal cannabis products that have been the subject of the authorised prescriber (AP) scheme or the Special Access Scheme (SAS) B.
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LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of prescription and other related medicines.
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LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of non-prescription medicines.
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LegislationThis Therapeutic Goods Order constitutes a standard for medicinal cannabis products.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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GuidanceGuidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93.
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GuidanceGuidance to assist sponsors and manufacturers of medicinal cannabis products to conform with TGO 100.