Transition to paperless (digital) access for unapproved therapeutic goods

This communique announces our plan to transition to a paperless model for Special Access Scheme (SAS) and Authorised Prescriber (AP) submissions.  From 1 July 2024 we will only accept submissions via the SAS/AP Online System - external site (the System). 

We intend to implement a staged approach to allow digital submissions only under the SAS and AP scheme from 1 July 2024. Paper and emailed submissions will not be accepted after the period. 

We believe that a gradual transition allows all stakeholders the opportunity to plan and develop internal processes in response to the proposed changes. The timeline noted below aims to provide healthcare practitioners and organisations currently submitting paper-based notifications with sufficient time to register to use the System. 

Proposed transition timeline:

Phase 1

• We will no longer accept paper-based submissions (i.e. faxed, emailed submissions) under the SAS Category B pathway or Authorised Prescriber scheme from 1 April 2024. 

Phase 2

• We will no longer accept paper-based submissions (i.e. faxed, emailed submissions) under the SAS Category A and C pathway from 1 July 2024.

The communique is intended for healthcare practitioners who have the need to access unapproved therapeutic goods for their patients.

Contents 

1.           Purpose

2.           Transition timeline

3.           Background

3.1         Improvements to the system

3.2         Current SAS and AP scheme utilisation data

3.3         Guidance and resources

4.           Why are we transitioning to a digital model?

4.1         Broader digital transformation

4.2         Quality assurance

4.3         Increasing compliance activities

5.           Communicating and managing changes