Accessing unapproved products
There are a number of ways that patients can gain access to products that have not been approved for use in Australia.
- Authorised prescribers
The TGA is able to grant medical practitioners authority to prescribe a specified unapproved therapeutic good or class of unapproved therapeutic goods to specified recipients or classes of recipients
- Special access scheme
The Special Access Scheme refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis
- Clinical trials
These documents describe the regulations for allowing patients access to unapproved medicines or medical devices by participation in a clinical trial.
- Personal import scheme
Describes how individuals can import unapproved therapeutic goods for personal use
- Human Research Ethics Committees and the therapeutic goods legislation
Describes the role of Human Research Ethics Committees (HRECs) in relation to the supply of unapproved therapeutic goods