TGA Reporting for Medicinal Cannabis: What Every Business Needs to Know - Part One
As Australia's medicinal cannabis industry continues to evolve, compliance expectations continue to grow. While many businesses focus on approvals and supplying products, ongoing reporting and record keeping remain some of the most important regulatory responsibilities.
Recent guidance from the Therapeutic Goods Administration (TGA) has reinforced a stronger focus on compliance across the medicinal cannabis sector. Along with reporting obligations, the regulator has increased its attention on advertising, governance and post-market monitoring, highlighting the need for strong internal compliance systems rather than simply meeting minimum reporting requirements (TGA, 2025).
In this first article of our two-part series, we explore the reporting responsibilities of clinics and prescribers, medicinal cannabis brands, and wholesalers.
Why TGA Reporting Matters
Reporting requirements help ensure medicines continue to meet Australia's standards for quality, safety and appropriate use after they reach the market.
Accurate reporting allows the TGA to monitor prescribing trends, identify potential safety concerns and oversee the responsible supply of medicinal cannabis products (TGA, 2025). Failure to meet reporting obligations can lead to compliance action, regulatory investigations and unnecessary administrative burden.
While reporting requirements differ depending on your role in the supply chain, having clear systems in place makes compliance much easier. Now, lets take a look at each stakeholders reporting requirements –
Clinics and Prescribers
Clinics and prescribers have different reporting obligations depending on the access pathway used.
For patients accessing medicinal cannabis through the Special Access Scheme Category B (SAS-B), an application is generally required for each individual patient. Every approval forms part of the regulatory record and should be supported by appropriate clinical documentation. As prescribing volumes grow, maintaining accurate records becomes increasingly important for both compliance and patient care (TGA, 2025).
The process differs under the Authorised Prescriber (AP) Scheme. Rather than submitting an application for every patient, Authorised Prescribers must submit reports to the TGA every six months outlining their prescribing activity. These reports are a condition of maintaining Authorised Prescriber status and help the TGA monitor how unapproved medicinal cannabis products are prescribed in Australia (TGA, 2025).
The TGA has also reminded clinics that compliance extends beyond reporting. Information collected for regulatory purposes should remain separate from marketing activities, and businesses should regularly review websites, booking systems and patient communications to ensure they do not unintentionally promote prescription medicines (TGA, 2025).
Medicinal Cannabis Brands & Sponsors
For sponsors and medicinal cannabis brands, compliance continues well after a product enters the Australian market.
Sponsors are required to submit six-monthly reports detailing product supply and other required information where applicable. These reports provide valuable oversight of products supplied within Australia and support ongoing regulatory monitoring (TGA, 2025).
Adverse event reporting is equally important. Sponsors are responsible for identifying, investigating and reporting suspected adverse events within the required regulatory timeframes. Reports may come from healthcare professionals, patients, customer service teams, distributors or other business partners.
As the TGA continues to strengthen post-market surveillance, sponsors should ensure their pharmacovigilance systems allow adverse events to be identified, assessed and reported promptly, with clearly documented responsibilities across the organisation (TGA, 2025).
Wholesalers
Although wholesalers generally have fewer formal reporting obligations than sponsors or prescribers, they play an important role in maintaining compliance across the supply chain.
Good Distribution Practice (GDP) requires wholesalers to maintain accurate records showing medicinal cannabis products have been stored, handled and distributed correctly. Distribution records, controlled drug registers (where required under state or territory legislation), and product recall documentation all help ensure products remain fully traceable (TGA, 2025).
Maintaining complete and accurate records also allows wholesalers to respond quickly if a product quality issue or recall occurs. As regulatory expectations continue to increase, businesses should regularly review their documentation and record management processes to ensure they remain current and audit-ready.
Looking Ahead
Reporting obligations vary across the medicinal cannabis industry, but they all support the same goal: protecting patient safety, maintaining product traceability and supporting regulatory oversight.
As the TGA strengthens its compliance approach, businesses should view reporting as just one part of a broader compliance framework that also includes governance, record keeping, pharmacovigilance and advertising compliance.
In Part Two of this series, we'll explore the responsibilities of importers, pharmacies, sponsors and manufacturers, and how these stakeholders contribute to maintaining a safe, transparent and compliant medicinal cannabis supply chain.
Learn More
EQWELLIBRIYUM offers end-to-end consulting for organisations navigating the medicinal cannabis market in Australia. With strategic insights and operational frameworks are designed to help you thrive, we’re here to help you. Learn more by contacting us today at hello@eqwellibriyum.com.
References
Therapeutic Goods Administration. (2025). Authorised Prescriber Scheme via. https://www.tga.gov.au/resources/explore-topic/medicinal-cannabis-hub/medicinal-cannabis-access-pathways-and-usage-data/medicinal-cannabis-authorised-prescriber-scheme-data
Therapeutic Goods Administration. (2025). Special Access Scheme (SAS). via. https://www.tga.gov.au/resources/explore-topic/medicinal-cannabis-hub/medicinal-cannabis-access-pathways-and-usage-data/medicinal-cannabis-special-access-scheme-data
Therapeutic Goods Administration. (2025). Medicinal cannabis hub. via. https://www.tga.gov.au/resources/explore-topic/medicinal-cannabis-hub
Therapeutic Goods Administration. (2025). Pharmacovigilance responsibilities of medicine sponsors. via. https://www.tga.gov.au/resources/guidance/pharmacovigilance-responsibilities-medicine-sponsors
Therapeutic Goods Administration. (2025). Guidance on the advertising of prescription medicines via. https://www.tga.gov.au/resources/guidance/pharmacovigilance-responsibilities-medicine-sponsors