Australian Government

  Freedom of information (FOI) FOI Disclosure Log Documents provided in response to an FOI request will be included in our  FOI Disclosure Log . However, personal information and information about the business, commercial, financial or professional affairs of a person will be deleted from the documents if publication of that information would be unreasonable. Documents available outside the FOI Act You should check the information we have published under the  Information Publication Scheme  and  FOI Disclosure Log  to see if the information you are seeking is already available. Recently the TGA provided a response to members of the public that were interested in accessing information regarding the safety and efficacy of the COVID-19 vaccines. Response to members of the public (pdf,238kb) How to make a request Your request must: be in writing state that the request is an application for the purposes of the FOI Act provide sufficient information about the doc...

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) 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.

  Australian Register of Therapeutic Goods (ARTG) The ARTG is the public database of therapeutic goods that can be legally supplied in Australia. You can search the ARTG to find details of therapeutic goods approved for supply. Information held in the ARTG includes: product name and formulation details sponsor (company) and manufacturer details. For more details and how to use the ARTG search function go to  Searching the Australian Register of Therapeutic Goods (ARTG) - external site - external site .  Search results from the ARTG include  Consumer Medicines Information (CMI) ,  Product Information (PI)  and Public Summary documents. Not all CMI and PI documents are available on this website. Access to therapeutic goods not on the ARTG As with many aspects of the regulatory framework, there are situations where special policies have been developed in response to the needs of particular people or circumstances. Information on these policies and the relevant...

 https://compliance.health.gov.au/sas/ SAS submissions  · Custom Portal (health.gov.au) Medical Cannabis Resources https://www.tga.gov.au/resource/special-access-scheme-sas-applications-quick-reference-guide

Therapeutic Goods Administration  https://www.tga.gov.au/ Telephone We are here Monday to Friday, 9:00 am to 5:00 pm (AEST) except on public holidays: calls from Australia (free call)  1800 020 653 calls from Australia  02 6289 4124 calls from overseas  +61 2 6289 4124 If you are deaf or have a hearing or speech impairment You can call us through the  National Relay Service - external site TTY or computer with modem users phone  1800 555 677  then ask for  1800 020 653 speak and listen users phone  1800 555 727  then ask for  1800 020 653 If you need help with English You can use the  Translating and Interpreting Service - external site : calls from Australia  131 450 calls from outside Australia  +61 3 9268 8332 Email info@tga.gov.au Fax 02 6203 1605 Post TGA, PO Box 100, Woden ACT 2606, Australia

  Australian Health Practitioner Regulation Agency - Home (ahpra.gov.au)