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Medicinal Cannabis. TGA Special Access Scheme (SAS)

doctor on tga website

The TGA has introduced an online system to enable the lodgement of SAS applications and notifications relating to medicinal cannabis.

The SAS online system will allow prescribers in certain States and Territories to submit an application to both the TGA and the relevant State/Territory Health Department simultaneously.

The system aims to reduce administrative burden and provide health practitioners and organisations, such as hospitals, with additional reporting and management functions to assist in the management of their SAS applications and notifications.

SAS CATEGORY B: APPLICATION PATHWAY

Category B is an application pathway that can be accessed by health practitioners. Category B applications must be reviewed and approved by TGA before the unapproved product may be accessed and supplied to the patient:

STEP 1.

MAKE AN ACCOUNT

Users of the system will be required to register an account before they can begin drafting and submitting online SAS applications and notifications to the TGA.

Details include:

  • A username, password and email address.
  • Personal information such as full name, health practitioner type
    and contact details.

Note: users who have registered with other systems hosted by the TGA should login (rather than register) using the username and password to which they registered with the first TGA system.

Upon registration of an account, health practitioners can then draft and submit SAS applications and notifications to the TGA.

 

STEP 2.

USER DASHBOARD

All registered account holders will have a personal dashboard that displays information specific to SAS applications and notifications they have drafted or submitted via the system. This portal will allow you to:

  • Track the status of an application.
  • Search previously submitted applications and notifications for reporting purposes using parameters such as patient details, product, prescriber, submission date and status (i.e. approved, rejected, withdrawn, completed).
  • Download a PDF copy of the application or notification to be saved locally.
  • Identify applications and notifications that are expiring or that have expired, prompting health practitioners to conduct a review of the patient's condition and resubmit SAS applications/notifications as required.
  • Download a copy of the TGA decision letter.
  • Clone (copy) previously submitted SAS submissions.

STEP 3.

SUBMIT AN SAS B APPLICATION

The online system has been designed to guide health practitioners when seeking access to unapproved therapeutic goods. The online system will determine which information is required by the TGA based on the specific application/notification using internal logic.

The system will use information provided by the user about the prescribing health practitioner type, the unapproved product and its proposed use to ensure use in accordance with regulatory requirements.

STEP 4.

APPLICATION REVIEW

The TGA and relevant State or Territory Health Department will each conduct their own evaluation processes on the information submitted via the system. As part of the evaluation process, the TGA and State or Territory Health Department may contact the prescriber seeking further information in support of the application.

STEP 5.

NOTIFICATION

The prescriber will receive a single email from the TGA containing both the TGA and state or territory outcome letters within 48 hours (2 business days) of having received all information required to evaluate the application.

STEP 6.

SUPPLY OF PRODUCT

If both state and TGA requirements are satisfied, then the pharmacy or hospital that the doctor has arranged to supply the product can dispense it.

For more information on the Special Access Scheme, please contact our team.