THE Therapeutic Goods Administration (TGA) has published an update about the Special Access Scheme (SAS), introducing Category C, a new accelerated notification pathway to drug access.
Category C allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval.
The goods will be specified in a list along with their indications and the type of health practitioner authorised to supply them.
There are separate lists for medicines, medical devices and biologicals, each with their own set of rules defining who is authorised and under what conditions.
In addition, the TGA has developed more guidance on access to medicinal cannabis products along with an SAS guidance tool for access to unapproved therapeutic goods, SAS guidance for health practitioners and sponsors and an SAS FAQ section together with new forms for each category.
Consent to treatment and indemnity for use forms are also included and information around importing controlled substances.
Visit tga.gov.au for all files.
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