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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.

NOTE: This document is being updated. Please see the individual publications for each mechanism of access for the most current information:

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Access to unapproved therapeutic goods in Australia (pdf,1.26Mb)*

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  • Australian Price (GST Inclusive): $50.00
  • Overseas Price (+ Airmail): $45.45 (+$25.00)

Contents

  1. The legal basis for supply of unapproved therapeutic goods
  2. Rights, responsibilities and roles in relation to the supply of unapproved therapeutic goods
  3. The history of clinical trials in Australia
  4. Clinical trials
    • Appendix 1. CTN form
    • Appendix 2. Clinical trial completion advice
    • Appendix 3. CTX form
    • Appendix 4. Particulars of the product and trial
    • Appendix 5. Documents for ethics committees
  5. The special access scheme (SAS)
    • Appendix 6. SAS Category A patients
    • Appendix 7. SAS Category B patients
    • Appendix 8. SAS consent to treatment and indemnity
  6. Authorised prescribers
    • Appendix 9.Authorisation of prescribers under section 19(5) of the Therapeutic Goods Act 1989
    • Appendix 10. Authorised prescriber - consent to treatment and indemnity
    • Appendix 11. HREC letter of endorsement for authorised prescribers
    • Appendix 12.General conditions of an authorisation under section 19(5) of the Therapeutic Goods Act
  7. Note for guidance on good clinical practice (CPMP/ICH/135/95) - annotated with comments of the TGA
  8. Reporting adverse events and reactions associated with the use of unapproved medicines
    • Appendix 13. ADRAC blue card
    • Appendix 14. Clinical trial event reporting algorithm for sponsors
    • Appendix 15. Adverse event reporting algorithm
  9. Note for guidance on clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95) - annotated with comments of the TGA
  10. Reporting of adverse outcomes associated with the use of unapproved medical devices
    • Appendix 16. Medical device incident report form
    • Appendix 17. Clinical trial event reporting algorithm for clinical trials
    • Appendix 18. Adverse event reporting algorithm for sponsors of medical devices supplied via SAS and authorised prescriber
  11. Appeal mechanisms
    • Appendix 19. The Therapeutic Goods Act 1989
  12. Personal importation

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