Submission

AMA submission to the TGA’s targeted consultation for the institution of legal provisions to share Special Access Scheme information

The Australian Medical Association (AMA) is broadly supportive of the Therapeutic Goods Association’s (TGA) proposed legislative instrument to enable the sharing of information with other regulators relating to therapeutic goods accessed via the unapproved therapeutic goods framework. The instrument should make it easier for regulators to address the exploitation of the Special Access Scheme (SAS) and the Authorised Prescriber Scheme (APS), predominantly perpetrated by vertically integrated, direct-to-consumer telehealth entities.