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121286 - Access to Unapproved Therapeutic Goods

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Therapeutic goods are required to undergo an evaluation for quality, safety and efficacy and be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. 
In recognition that there are circumstances where patients need access to therapeutic goods that are not included in the ARTG, the TGA manages the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme. These schemes allow Australian registered medical professionals access to unapproved therapeutic goods for patients where the use of registered products is unavailable or has been deemed clinically unsuitable.

Relevance to General Practice

The aim of this CPD module is to educate medical professionals on the Special Access Scheme and Authorised Prescriber Scheme. Specifically, this module aims to educate medical professionals as to when it is appropriate to access goods via these pathways, the associated processes and the roles and responsibilities of medical professionals when accessing goods via these pathways.

Learning outcomes
  • Differentiate between the Special Access Scheme pathways and when it is appropriate for each to be accessed.
  • Identify suitability to apply to become an Authorised Prescriber, utilise the correct application process and recognise the role of the HRECs & spec. colleges.
  • Distinguish the roles and responsibilities of the prescribing medical professional (& other health profs. ) when accessing goods under the SAS & AP Scheme.
  • Ensure the use of unapproved therapeutic goods in Australia is in alignment with the principles of quality use of medicines and good medical practice.
  • Delivery
    121286 - Access to Unapproved Therapeutic Goods
    2 hours
    Start Date
    End Date
    CPD Points
    2 hours
    Contact Phone
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