This guidance is for medical practitioners, Human Research Ethics Committees (HRECs), specialist colleges and sponsors of 'unapproved' therapeutic goods and provides information about the:
- Authorised Prescriber scheme
- roles and responsibilities of HRECs, specialist colleges, Authorised Prescribers, sponsors and TGA in relation to the Authorised Prescriber scheme
- legal basis for supply of 'unapproved' therapeutic goods
This guidance also provides details about relevant amendments to the Therapeutic Goods Regulations 1990 to streamline the application process for medicines considered to have an established history of use.
Contents
- About this guidance
- How to become an Authorised Prescriber
- Information for Medical Practitioners
- Information for HRECs and specialist colleges
- Information for sponsors
- Legal basis of the scheme.
Page history
Version | Description of change | Author | Effective date |
V2.0 | Access to ‘unapproved’ Therapeutic Goods (Authorised Prescriber Scheme) | TGA | October 2004 |
V3.0 | New title New material aligned with MMDR Review recommendations Restructured | Pharmacovigilance and Special Access Branch and Regulatory Guidance Team | July 2017 |
V4.0 | Updated to include guidance on regulatory amendment and application pathways Other minor updates to clarify list of HRECs, types of medical practitioners, specialist college definition, adverse event terminology, six monthly reporting | Pharmacovigilance and Special Access Branch and Regulatory Guidance Team | October 2020 |
V5.0 | Review and addition of information relating to subregulation 12B(1C), six monthly reporting and use of the online portal | Experimental Products Section - International Regulatory Branch | November 2021 |
V5.1 | Minor updates under reporting requirements in section 22. Link and email updates for sponsor reporting. | Experimental Products Section - International Regulatory Branch | February 2022 |
V5.2 | Minor updates under reporting requirements. Link and email updates for sponsor reporting. | Special Access Section - International Regulatory Branch | December 2022 |
V5.3 | Minor updates relating to the SAS and AP Online System | Business Improvement and Compliance Section- International Regulatory Branch | March 2024 |
Version | Description of change | Author | Effective date |
V2.0 | Access to ‘unapproved’ Therapeutic Goods (Authorised Prescriber Scheme) | TGA | October 2004 |
V3.0 | New title New material aligned with MMDR Review recommendations Restructured | Pharmacovigilance and Special Access Branch and Regulatory Guidance Team | July 2017 |
V4.0 | Updated to include guidance on regulatory amendment and application pathways Other minor updates to clarify list of HRECs, types of medical practitioners, specialist college definition, adverse event terminology, six monthly reporting | Pharmacovigilance and Special Access Branch and Regulatory Guidance Team | October 2020 |
V5.0 | Review and addition of information relating to subregulation 12B(1C), six monthly reporting and use of the online portal | Experimental Products Section - International Regulatory Branch | November 2021 |
V5.1 | Minor updates under reporting requirements in section 22. Link and email updates for sponsor reporting. | Experimental Products Section - International Regulatory Branch | February 2022 |
V5.2 | Minor updates under reporting requirements. Link and email updates for sponsor reporting. | Special Access Section - International Regulatory Branch | December 2022 |
V5.3 | Minor updates relating to the SAS and AP Online System | Business Improvement and Compliance Section- International Regulatory Branch | March 2024 |
This webpage on the TGA website was printed on 18 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/authorised-prescriber-scheme