By Dr. Paul Crosio
The global demand for medical cannabis has seen significant growth in recent years, with countries like Thailand and Australia playing important roles in both production and importation. Thailand, having legalized medical cannabis in 2018, is now positioning itself as a key player in the global medical cannabis industry. At the same time, Australia has developed a highly regulated market for medical cannabis use. This article is a guide for anyone interested in exporting medical cannabis from Thailand to Australia, focusing on the regulatory environment, procedures, and compliance requirements.
Overview of the Regulatory Environment
Thailand’s Medical Cannabis Framework
Thailand made history in Southeast Asia by becoming the first country to legalize medical cannabis in 2018. This was a significant milestone for the country and the region, as it opened new avenues for cannabis cultivation, production, and export. The Thai Food and Drug Administration (FDA), under the Ministry of Public Health, is responsible for regulating the cultivation, production, and export of cannabis. Cannabis businesses must comply with strict regulations, including obtaining cultivation licenses and ensuring that cannabis products meet the required standards of safety and efficacy.
In 2021, Thailand’s government relaxed laws surrounding cannabis production, allowing private entities, including foreign companies, to participate in cannabis cultivation under contract with Thai hospitals or research institutions. This shift presents a lucrative opportunity for exporters.
In 2024, a Draft Cannabis Bill was announced, which will regulate production and move to an international GACP standard for grows. This bill seeks to “weed out” illegal and unregulated operators and focus on medical-quality operations. Details are sketchy, but some form of track and trace and reporting regime is likely. All this augers well for placing Thailand on the list of high-quality exporters of medical cannabis.
Australia’s Strict Regulatory Framework
On the other hand, Australia maintains a rigorous regulatory system for the importation and dispensing of medical cannabis. Under the Department of Health, the Therapeutic Goods Administration (TGA) regulates the import, distribution, and prescription of medical cannabis products. Medical cannabis in Australia is classified as either Schedule 4 (prescription-only medicines) or Schedule 8 (controlled drugs), depending on the THC content, with more than 2% THC classifying it as Schedule 8. Exporters should ensure that their products align with these classifications to avoid legal issues during importation.
The two primary pathways for the legal importation of medical cannabis into Australia are:
- The Authorised Prescriber Scheme (AP): This allows health practitioners to prescribe cannabis for a specific group of patients.
- The Special Access Scheme (SAS): This permits the importation of medical cannabis on a case-by-case basis for patients not part of an ongoing clinical trial.
Steps to Export Medical Cannabis from Thailand to Australia
- Ensure Compliance with Thai Export Laws
Before exporting, companies must ensure full compliance with Thai regulations governing the export of medical cannabis. The Thai FDA is the key authority here, and it requires:
- A valid cultivation or production license.
- Product quality standards that comply with Good Manufacturing Practices (GMP).
- Export licenses issued by the Ministry of Public Health.
Products should also meet specific health and safety standards set for export, and only medical cannabis products approved by the Thai FDA are eligible for export.
- Register with Australian Authorities
Before your products can be legally imported into Australia, the TGA must approve them. Given that most cannabis medicines available in Australia are unregistered, the SAS or AP Scheme will be your main pathway. However, the exporting company must:
- Provide evidence that the product meets Australian quality and safety standards as per TGA guidelines.
- Be aware that unregistered cannabis products are treated as Schedule 8 substances, meaning stringent storage and prescription regulations apply. For example, these products must be stored in secured, approved facilities and cannot be kept in stock without a valid prescription.
- Engage with an Importer
Working with a licensed Australian importer is essential. The importer will facilitate the necessary TGA approvals and ensure compliance with Australian customs laws. According to the Narcotic Drugs Act 1967 and Therapeutic Goods Act 1989, the importer will need to:
- Apply for an import permit from the Office of Drug Control (ODC) in Australia.
- Ensure that the product aligns with the Therapeutic Goods (Standard for Medicinal Cannabis) Order 2017, which governs the quality of cannabis products entering Australia.
- Understand Customs and Quarantine Requirements
Upon arriving in Australia, the Australian Border Force will subject your product to customs checks and potential quarantine. Ensure that all documentation is correct and that the cannabis products meet Australian law’s labeling and packaging standards. Products must:
- Be accurately labeled, detailing the cannabinoid content and manufacturer.
- Be stored according to TGA requirements, particularly for Schedule 8 products.
The Australian Department of Agriculture may also perform quarantine checks to ensure the product complies with biosecurity laws, especially if it is raw or dried.
Key Considerations for Exporters
- Product Quality
Ensuring product quality is vital. Not only does it affect patient safety, but poor-quality products that fail to meet Australian standards may be rejected by customs. Thailand’s cannabis producers must adhere to GMP to ensure the product’s purity, consistency, and potency.
- Partnerships with Medical Professionals
In Australia, medical cannabis can only be prescribed by authorized health practitioners under the SAS or AP Scheme. Partnering with these practitioners or companies experienced in the Australian cannabis sector can help streamline the process. Additionally, many patients seek cannabis treatments as a last resort, meaning your product must be backed by rigorous evidence and clinical data.
- Evolving Legal Landscape
Both Thailand and Australia’s cannabis industries are evolving rapidly. In Thailand, laws surrounding cultivation and export may continue to relax as the government seeks to bolster its cannabis industry. In Australia, while the medical cannabis sector has grown, public access remains highly regulated. Staying current on these legal changes is essential to maintaining compliance and seizing new opportunities.
Conclusion
The medical cannabis industry presents a growing export opportunity for Thailand, particularly as demand in Australia continues to rise. However, navigating the complex regulatory frameworks in both countries requires careful planning and compliance with all legal requirements. Exporters should focus on meeting stringent quality standards, securing the proper licenses, and establishing partnerships with Australian importers and healthcare professionals to ensure a successful entry into this lucrative market.
With proper due diligence and an understanding of Thai and Australian regulations, Thailand-based producers can become key players in the global medical cannabis supply chain.
Silk Legal can provide various assitance in several practice areas, including cannabis and regulatory services. This article is for information only. While we have tried to keep our updates as accurate as possible, changes to legislation or other factors may affect your decisions. Please feel free to contact us for a free consultation at [email protected].
