Access to unapproved therapeutic goods - Special Access Scheme
These guidelines describe how to obtain approval for the supply of an unapproved therapeutic good (medicine, 'other therapeutic goods' or medical devices) under the Special Access Scheme and how to obtain the product once approval for supply has been given.
Access to unapproved therapeutic goods - Special Access Scheme (pdf,345kb)
Contents
- These guidelines
- Introduction
- The Special Access Scheme (SAS) - a brief overview
- Rights and responsibilities under the Special Access Scheme
- How to determine if a patient is Category A or Category B
- The arrangements for supply to Category A patients
- The arrangements for supply to Category B patients
- Requests for approval to supply unapproved products derived from biological tissue including human blood or plasma
- How to obtain an unapproved medicine or medical device once approval for supply has been obtained
- Reporting of adverse outcomes associated with the use of unapproved therapeutic goods under the SAS
- What to do if the SAS application is rejected
- Appendices
- Appendix 1 Special Access Scheme authority to supply for Category A patients
- Appendix 2 Special access Scheme (SAS) request for Category B patients
- Appendix 3 Consent to treatment and indemnity for use of products derived from biological tissue including human blood or plasma
- Appendix 4 ADRAC 'blue card'
- Appendix 5 Medical device incident report form