Access Pathways to Medical Cannabis: Authorised Prescriber Scheme
-
Overview
In Australia, the Therapeutic Goods Administration (TGA) regulates the approval and monitoring of medications to ensure their quality, safety, and efficacy.¹ However, many medical cannabis products are classified as unapproved goods, as they have not undergone TGA evaluation.
This module provides a detailed overview of the TGA's Authorised Prescriber Scheme, which enables registered medical practitioners to apply for the authority to prescribe unapproved medical cannabis products to multiple patients.²
Learners will gain a clear understanding of the regulatory framework, the application process, and the responsibilities involved in prescribing unapproved medical cannabis products. This module is designed to equip healthcare practitioners with the knowledge to navigate the scheme effectively and confidently integrate medical cannabis into patient care when appropriate.
Preview this module by watching the video above.
Estimated Duration: 1 hour
Access Duration: 12 months from date of purchase
Learning Outcomes
Upon completion of this module, you’ll be able to:
- Clarify the purpose of the Australian Register of Therapeutic Goods (ARTG)
- Outline the categories of unregistered therapeutic goods
- Identify and explain the regulated access pathways for unapproved goods
- Summarise the purpose and eligibility criteria for each category of the Special Access Scheme (SAS), including SAS-A, SAS-B, and SAS-C
- Identify the information required for a SAS-B application
- Identify the main categories of medical cannabis products based on their CBD and THC content
- Summarise the purpose and main characteristics of each Authorised Prescriber Scheme pathway
- Apply to become an authorised prescriber and fulfil reporting obligations
- Discuss prescribing practitioner considerations and obligations for providing medical cannabis treatment
References
¹ Therapeutic Goods Administration. “Prescribe an Unapproved Therapeutic Good (Health Practitioners).” Therapeutic Goods Administration (TGA), 14 Dec. 2022, www.tga.gov.au/products/unapproved-therapeutic-goods/prescribe-unapproved-therapeutic-good-health-practitioners.
² Therapeutic Goods Administration. Unapproved products for multiple patients (Authorised Prescriber). Therapeutic Goods Administration (TGA). Published July 14, 2023. Accessed November 28, 2024. https://www.tga.gov.au/services/unapproved-products-multiple-patients-authorised-prescriber
Overview
In Australia, the Therapeutic Goods Administration (TGA) regulates the approval and monitoring of medications to ensure their quality, safety, and efficacy.¹ However, many medical cannabis products are classified as unapproved goods, as they have not undergone TGA evaluation.
This module provides a detailed overview of the TGA's Authorised Prescriber Scheme, which enables registered medical practitioners to apply for the authority to prescribe unapproved medical cannabis products to multiple patients.²
Learners will gain a clear understanding of the regulatory framework, the application process, and the responsibilities involved in prescribing unapproved medical cannabis products. This module is designed to equip healthcare practitioners with the knowledge to navigate the scheme effectively and confidently integrate medical cannabis into patient care when appropriate.
Preview this module by watching the video above.
Estimated Duration: 1 hour
Access Duration: 12 months from date of purchase
Learning Outcomes
Upon completion of this module, you’ll be able to:
- Clarify the purpose of the Australian Register of Therapeutic Goods (ARTG)
- Outline the categories of unregistered therapeutic goods
- Identify and explain the regulated access pathways for unapproved goods
- Summarise the purpose and eligibility criteria for each category of the Special Access Scheme (SAS), including SAS-A, SAS-B, and SAS-C
- Identify the information required for a SAS-B application
- Identify the main categories of medical cannabis products based on their CBD and THC content
- Summarise the purpose and main characteristics of each Authorised Prescriber Scheme pathway
- Apply to become an authorised prescriber and fulfil reporting obligations
- Discuss prescribing practitioner considerations and obligations for providing medical cannabis treatment
References
¹ Therapeutic Goods Administration. “Prescribe an Unapproved Therapeutic Good (Health Practitioners).” Therapeutic Goods Administration (TGA), 14 Dec. 2022, www.tga.gov.au/products/unapproved-therapeutic-goods/prescribe-unapproved-therapeutic-good-health-practitioners.
² Therapeutic Goods Administration. Unapproved products for multiple patients (Authorised Prescriber). Therapeutic Goods Administration (TGA). Published July 14, 2023. Accessed November 28, 2024. https://www.tga.gov.au/services/unapproved-products-multiple-patients-authorised-prescriber