Special Access Scheme online system
THE Therapeutic Goods Administration has released details of its new online system to enable the electronic submission of Special Access Scheme (SAS) applications and notifications to the TGA.
This month the system was updated to allow the submission of Authorised Prescriber applications, with the system aiming to reduce the adminstrative burden on health practitioners.
While lodgement of SAS and AP applications and notifications via the online system is not mandatory, it is the preferred method of submission, with the TGA aiming to move the submission of all SAS and AP requests online by 01 Jul 2019.
The TGA noted that in certain circumstances the SAS online system should not be used for medicinal cannabis submissions.
Such situations include where the prescriber of the unapproved therapeutic good is not a medical practitioner, or where the prescriber is in possession of a current TGA approval and the notification/application only relates to a particular state or territory.
Medical practitioners actually prescribing the medicinal cannabis product must make the submission via the system - tga.gov.au.