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MMDR: Accessing unapproved products reforms

14 November 2018

Reforms to the regulation of patient-specific access to therapeutic products have been implemented in response to the recommendations arising from the Review of Medicines and Medical Devices Regulation.

The reforms include modifications to the Special Access Scheme and Authorised Prescriber scheme to allow streamlined access to certain unapproved therapeutic products.

Reforms

Special Access Scheme Category C notifications

Introduction of a notification pathway, rather than the standard pre-approval pathway, that allows certain types of health practitioners to supply unapproved therapeutic goods considered to have an established history of use.

Special Access Scheme online system

Introduction of an online system to enable the electronic submission of Special Access Scheme applications and notifications.

Streamlined application process for Authorised Prescribers

Changes to the Authorised Prescriber Scheme allowing for a more streamlined application process to improve access to required unapproved therapeutic goods.

Further information

MMDR consultations

All consultations related to the Medicines and Medical Devices Regulation Review

Consultations conducted in relation to accessing unapproved products.

Up-to-date information about the reforms and their status.

Information on the Review of Medicines and Medical Devices Regulation, including links to the complete Review and the Australian Government's response.