Access to unapproved therapeutic goods - Authorised prescribers
This publication describes how medical practitioners can obtain approval as an 'Authorised Prescriber' for the purpose of supplying an unapproved therapeutic good (medicine, 'other therapeutic goods' or medical device) under Section 19(5) and Section 41HC of the Therapeutic Goods Act 1989, and their obligations arising from such authorisations.
Access to unapproved therapeutic goods - Authorised prescribers (pdf,342kb)
Contents
- These guidelines
- Introduction
- Basic principles governing the supply of unapproved products using the Authorised Prescriber mechanism
- The TGA's attitude toward existing Section 19(5)/41HC Authorisations when another product is registered for treatment of the specific condition
- How to become an Authorised Prescriber
- The role of the ethics committee
- Circumstances under which TGA may revoke an Authorisation
- How to obtain an unapproved medicine or medical device once Authorisation has been granted
- Reporting of adverse outcomes associated with the use of unapproved therapeutic goods
- What to do if your application to become an Authorised Prescriber is rejected
- Appendices
- Appendix 1 General conditions of an Authorisation under Section 19(5)/41HC
- Appendix 2 'Agreement to Treatment Directions' form
- Appendix 3 Consent to Treatment and Indemnity for Use of Products Derived from Human Blood or Plasma
- Appendix 4 HREC Letter of endorsement for Authorised Prescribers
- Appendix 5 ADRAC 'blue card' for reporting adverse medicine reactions
- Appendix 6 Medical Device Incident Report