Posts

Showing posts with the label AP

SAS & AP online system

SAS & AP online system In order to reduce the administrative burden of making SAS and AP applications, the TGA has created the  SAS/AP Online System - external site , which provides a single application point for Commonwealth and state/territory authorisations for medicinal cannabis products. Applications are reviewed by both the TGA and state/territory within 2 business days of submission. Further information on the SAS online system and details on the submission of medicinal cannabis applications can be found at:  Special Access Scheme and Authorised Prescriber online system .

Authorised Prescriber Scheme (AP)

Authorised Prescriber Scheme (AP) Any Australian registered medical practitioner can become an AP. The TGA is able to grant a medical practitioner authority to prescribe a specified unapproved medicinal cannabis product for particular indications to a class of patients in their immediate care. To become an AP, a medical practitioner must obtain approval from a Human Research Ethics Committee (HREC) or endorsement from an appropriate specialist college to prescribe the product. Prescribers do not need HREC approval or specialist college endorsement if the selected medicine's active ingredient category, dosage form and indication is included in the TGA's  List of medicinal cannabis medicines with established history of use . APs do not need to notify the TGA each time they prescribe medicinal cannabis products during the approval period (up to 5 years). APs must report the number of patients they treat every 6 months, even if the number is zero.