Access to unapproved therapeutic goods in Australia
Consolidated information
This document is a consolidation of the information about the mechanisms and regulations that allow patients to access unapproved medicines or medical devices in Australia.
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Access to unapproved therapeutic goods in Australia (pdf,1.26Mb)
Information for each mechanism of access is also provided inthe following documents:
- Authorised prescribers
<http://www.tga.gov.au/docs/html/authpres.htm> - Clinical trials in Australia
<http://www.tga.gov.au/docs/html/clintrials.htm> - Personal importation
<http://www.tga.gov.au/docs/html/personalimp.htm> - Special Access Scheme
<http://www.tga.gov.au/docs/html/sasinfo.htm>
Hardcopies of this document
If you require this document in hardcopy please complete a publications order form. Payment must accompany the order.
- Australian Price (GST Inclusive): $50.00
- Overseas Price (+ Airmail): $45.45 (+$25.00)
Contents
- The legal basis for supply of unapproved therapeutic goods
- Rights, responsibilities and roles in relation to the supply of unapproved therapeutic goods
- The history of clinical trials in Australia
- Clinical trials
- The special access scheme (SAS)
- Authorised prescribers
- Note for guidance on good clinical practice (CPMP/ICH/135/95) - annotated with comments of the TGA
- Reporting adverse events and reactions associated with the use of unapproved medicines
- Note for guidance on clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95) - annotated with comments of the TGA
- Reporting of adverse outcomes associated with the use of unapproved medical devices
- Appeal mechanisms
- Personal importation