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These notification pathways do not require approval from the TGA. You will not receive acknowledgement from us when you make a SAS Category A or Category C notification. The prescribing health practitioner also accepts responsibility for the use of an 'unapproved' therapeutic good and any associated adverse reactions. The responsibilities of the prescribing health practitioner include adhering to relevant standards of good medical practice and obtaining informed consent. Therefore, the prescribing health practitioner must consider the available evidence to support the use of the 'unapproved' product and any potential risks for the individual patient. 'Unapproved' therapeutic goods have not been evaluated by us for quality, safety, efficacy or performance. Individual patients should discuss the suitability of using an 'unapproved' therapeutic good with a health practitioner. SAS applications and notifications can only be submitted by certain registered health practitioners. On this page: Submission by a health practitioner | SAS Pathways | Guidance and FAQs | Forms | SAS Forms | Contact details for enquiries about the Special Access Scheme Submission by a health practitioner
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Submitting an application or notification through the SAS Online System will reduce processing times. If you are seeking to access medicinal cannabis products, please go to the Access to medicinal cannabis products web page. Medical practitioners that wish to access an 'unapproved' therapeutic good for a class of patients rather than an individual should visit the Authorised Prescribers web page.