Special Access Scheme (SAS) Applications - Quick Reference Guide (tga.gov.au)

-

 Special Access Scheme (SAS) Applications - Quick Reference Guide (tga.gov.au)

Comments

Post a Comment

Popular posts from this blog

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.
Read more

Freedom of information (FOI)

-
  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...
Read more