Helping Cannabis Businesses Succeed Within Australia’s Regulatory Framework
The Australian medicinal cannabis industry presents significant commercial opportunity, but also complex regulatory risk. From licensing, warehousing and advertising to telehealth operations and ethical governance, compliance is critical to building a sustainable and legally sound business.
At Lodestar Legal, our medicinal cannabis lawyers advise corporate clients across the entire supply chain, including cultivators, manufacturers, distributors, pharmacies, and telehealth operators. We provide practical, commercially focused guidance on ODC licensing, TGA compliance and corporate governance in the cannabis sector.
ODC Licensing and Regulatory Oversight
Under the Narcotic Drugs Act 1967 (Cth), the Office of Drug Control (ODC) oversees the licensing and permit system for the cultivation, production and manufacture of medicinal cannabis. Each licence carries strict security and reporting obligations.
Our regulatory lawyers assist with:
- Preparing and lodging ODC licence and permit applications;
- Developing compliance frameworks for site inspections; and
- Responding to ODC investigations or audits.
- Responding to TGA correspondence and compliance activities.
Medicinal cannabis products must also meet requirements under the Therapeutic Goods Act 1989 (Cth) and may be registered on the Australian Register of Therapeutic Goods (ARTG) or accessed via the Special Access Scheme (SAS).
Advertising and Consumer Law
The Therapeutic Goods Advertising Code prohibits the advertising of prescription medicines, including medicinal cannabis, directly to the public. Even indirect promotions – such as digital marketing or public webinars – can attract penalties if they are deemed to promote therapeutic goods.
Our TGA compliance lawyers review marketing campaigns, product websites and investor materials to ensure all communications are lawful and transparent under the TGA and Australian Consumer Law.
Managing Conflicts in Vertically Integrated Business Models
Many cannabis businesses operate vertically integrated models, combining cultivation, prescribing and dispensing within one structure. While legally permissible, these arrangements can create conflicts of interest under medical and ethical standards.
We advise on corporate governance, separation of clinical decision-making from commercial interests, and compliance with the Medical Board of Australia’s Good Medical Practice Code of Conduct.
Telehealth, RTPM, and Cross-Jurisdictional Compliance
Online clinics and telehealth models are key drivers of growth in the medicinal cannabis industry. However, these businesses must manage the regulatory requirements of each state and territory, including Real-Time Prescription Monitoring (RTPM) participation and practitioner registration.
Our team helps clients develop compliant telehealth structures, draft contractual arrangements between prescribers and pharmacies, and implement secure data handling procedures in line with Australian privacy law.
Enforcement Defence and Dispute Resolution
We represent clients in TGA and ODC investigations, as well as commercial disputes arising from supply agreements or joint ventures. Our approach combines strong advocacy with industry insight to protect your commercial interests while maintaining regulatory compliance.
How We Help Corporate Clients
Our medicinal cannabis lawyers provide integrated legal support across:
- ODC licensing and compliance reviews
- TGA and advertising law advice
- Corporate governance and ethical risk management
- Telehealth and digital health compliance
- Regulatory investigations and enforcement defence
At Lodestar Legal, we help cannabis businesses grow with confidence. Our team’s deep understanding of Australia’s medicinal cannabis regulations ensures that your operations are compliant, ethical, and built for long-term success.
Got questions about operating a medicinal cannabis business? Contact us.