Anavex Life Sciences Corp (AVXL)

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Special Access Scheme: frequently asked questions


“Category B is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through Category C. An approval letter from TGA is required before the good may be accessed. Approvals for medicines accessed through this pathway are typically only issued to medical and dental practitioners.

“Who can apply for access to therapeutic goods via the SAS pathways?


“Applications and notifications made under the SAS pathways are completed and submitted by registered health practitioners, preferably the prescribing health practitioner, who is best placed to determine the needs of the patient, including whether or not treatment with a particular product is required. It is expected that, in accordance with good medical practice, a health practitioner will educate themselves with all relevant and available information about a therapeutic good before using it.”


“What is the process for submitting a Category B application form?


The prescribing health practitioner or someone acting on their behalf can submit an application to the TGA to gain access to an unapproved therapeutic good for a patient that does not fit the Category A definition. Approval of an application to supply a product is required from a delegate in the TGA. Approval by the TGA is given on a patient-by-patient basis to reflect the needs of different patients. Applications can be made by lodging a completed Category B application form with the TGA).



https://www.tga.gov.au/special-access-scheme-frequently-asked-questions