Welcome to MarijuanDoctor.com.au, your trusted resource for medical practitioners seeking to prescribe medical cannabis. At MOCA Health, we understand the importance of providing accurate information and guidance to healthcare professionals interested in incorporating medical cannabis into their practice.

As a medical practitioner, it's crucial to stay informed about the regulations and guidelines set forth by the Therapeutic Goods Administration (TGA). The TGA is the regulatory authority responsible for overseeing the quality, safety, and efficacy of therapeutic goods in Australia. Their website offers valuable guidance on prescribing medical cannabis, including eligibility criteria, dosing recommendations, and reporting requirements. We encourage you to visit the TGA website for up-to-date information to ensure you're well-informed and compliant.

To further support your journey into medical cannabis prescribing, we provide useful links to state health websites. These websites offer state-specific information, regulations, and resources related to medical cannabis. By accessing these links, you can familiarise yourself with the requirements and processes in your jurisdiction, ensuring you have a comprehensive understanding of the landscape.

Additionally, we want to highlight the concept of authorized prescribers. Authorised prescribers are medical practitioners who have obtained the necessary approval to prescribe medical cannabis without needing to seek individual patient approvals from the TGA. This streamlined process enables authorised prescribers to provide timely access to medical cannabis for eligible patients. If you're interested in becoming an authorised prescriber, we can guide you through the application process and provide support along the way.

At MOCA Health, we are dedicated to fostering a community of knowledgeable and compassionate medical practitioners who are committed to improving patient outcomes through medical cannabis. We offer comprehensive training and education programs to enhance your understanding of medical cannabis and its therapeutic potential. Our team of experts is available to answer any questions you may have and provide ongoing support as you integrate medical cannabis into your practice.

By joining MarijuanDoctor.com.au, you gain access to a wealth of resources, tools, and a network of like-minded professionals. We believe in collaboration and knowledge-sharing, creating a space where medical practitioners can learn from one another and collectively contribute to advancing medical cannabis care in Australia.

Take the first step towards expanding your medical practice and empowering your patients with the benefits of medical cannabis. Join our community at MarijuanDoctor.com.au and embark on a transformative journey towards providing personalised and effective treatment options for your patients. Together, we can shape the future of healthcare.

I have been asked by a patient to prescribe an unapproved medicinal cannabis product. Do I have an obligation to prescribe it?

The responsibility and decision to prescribe any therapeutic good, including unapproved products rests with the prescriber. You have the right to decline to prescribe a medicinal cannabis product if you believe there is insufficient clinical justification or evidence to support the safe and effective use of the product.

It is important to note that the prescriber and patient (or patient's parents or guardian) through informed consent accept responsibility for any adverse consequence of therapy using an unapproved medicinal cannabis product.

I would like to prescribe a medicinal cannabis product, what access pathway should I use?

There are a number of mechanisms to enable access to unapproved medicinal cannabis products including:

• access for individual patients through either:

  • AP scheme

  • SAS

• access as part of a clinical trial.

How do I submit a SAS application for an unapproved medicinal cannabis product?

As of 30 July 2018 an online system was introduced to enable the submission of SAS applications and notifications electronically. The TGA has collaborated with state and territory health departments to streamline the application process for access to unapproved medicinal cannabis products in Australia.

The SAS online system allows prescribers in certain states and territories to submit an application to both the Commonwealth and the relevant state/territory health department simultaneously.

Further information on the SAS online system and details on the submission of medicinal cannabis applications can be found at: Special Access Scheme online system

Standard SAS forms can be used as required and are available on the SAS webpage. If using these application forms, a separate application may need to be made to the relevant state or territory health department depending on the circumstances. All prescribers are strongly encouraged to be aware of any state or territory requirements prior to prescribing unapproved medicinal cannabis products.

How do I submit an AP application form?

Applications for AP use the standard forms available on the Authorised prescriber page.

Will the TGA only allow me to access a particular product?

No. Any unapproved medicinal cannabis product can be potentially be accessed under the SAS or AP scheme. It is the responsibility of the prescriber to specify which product they wish to access. The TGA does not maintain a list of unapproved medicinal cannabis products.

Are there specific medical conditions for which the TGA will allow access to medicinal cannabis?

No. It is the responsibility of the prescriber to determine whether the specific product is suitable for the condition being treated based on clinical justification and evidence. The TGA has published guidance documents that prescribers may find useful when considering treatment with medicinal cannabis.

Do I need both TGA (Commonwealth) and state/territory approval to use medicinal cannabis?

Depending on the product, both Commonwealth and state/territory approval is required. Prescribers should confirm local requirements with their state/territory health department.

What level of clinical evidence is expected to support an application to access medicinal cannabis for my patient(s)?

The efficacy and safety data submitted in support of the application should be weighed against the seriousness of the condition. Please also include details of intended monitoring of the patient once treatment commences. Please see the SAS guidance for health practitioners and sponsors for more detailed information about what information to include in a SAS application.

Does the TGA publish a list of Authorised Prescribers?

For privacy reasons, the TGA does not publish a list of Authorised Prescribers who have been authorised to supply medicinal cannabis products under the Therapeutic Goods Act 1989.

Furthermore, in Australia doctors are not allowed to advertise to the public that they are able to prescribe a particular medicine. This is not just a matter relating to the Therapeutic Goods legislation, but also to the standards upheld by the Australian Health Practitioner Regulation Agency and the Medical Board of Australia and goes to matters of medical ethics and good medical practice.

The TGA has approved or authorised my application to become an Authorised Prescriber but the state/territory has not granted me the necessary approval to treat a named patient with the product I have been authorised to supply. Can I still use the product on the named patient?

Authorisation from the TGA to supply a specific medicinal cannabis product to treat the class of patients as per the authorisation does not override any state/territory requirements.

What is the relevance of the Standard for Medicinal Cannabis (TGO No. 93)?

Compliance with this standard provides an assurance to the medical practitioner that the product they intend to prescribe to their patient(s) meet a high standard of quality, consistent with what is expected of a pharmaceutical grade product.

Am I required to complete the form declaring that the medicinal cannabis product conforms with the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017?

No. The sponsor/manufacturer should complete this form and submit it to the TGA directly or to you, the medical practitioner, for you to submit to the TGA as supporting documentation for your SASB or AP application.

Does the TGA charge a fee to process my notification or application to access medicinal cannabis products through the SAS or the AP scheme?

No.

I have submitted a notification through SAS (Category A) or obtained approval/authorisation to supply the unapproved medicinal cannabis product through the SAS (Category B)/ AP scheme. What if the sponsor of the goods will not supply it?

A sponsor is under no obligation to supply an unapproved product merely because it has been notified to, approved or authorised under the SAS or the AP scheme respectively.

You are advised to contact the sponsor and ensure that they will agree to supply once appropriate approvals are received before making a notification or application to the TGA.

https://www.tga.gov.au/access-medicinal-cannabis-products-frequently-asked-questions-faqs