Access to Unapproved Therapeutic Goods

Description

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.

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.

Type
2 hours Online Learning

Accreditation
ACRRM 2 PDP
RACGP 4 QI&CPD points

 

Learning Outcomes

  1. Differentiate between the Special Access Scheme (SAS) pathways and when it is appropriate for each to be accessed
  2. Identify when it is suitable to apply to become an Authorised Prescriber (AP), utilise the correct application process and recognise the role of the Human Research Ethics Committees (HRECs) and specialist colleges
  3. Distinguish the roles and responsibilities of the prescribing medical professional (and other health professionals) when accessing goods under the SAS and AP Scheme
  4. Ensure the use of unapproved therapeutic goods in Australia is in alignment with the principles of quality use of medicines and good medical practice

Topics

  • Module overview
  • Special Access Scheme (SAS)
  • Authorised Prescriber (AP) Scheme.

 

Focus
Therapeutic Goods, SAS, AP, prescription, regulations, safety regulations

Medical Audience
GP, GP Registrar, Specialist, Doctors in Training (DIT), Medical Student, International Medical Graduate, Overseas Trained Doctor

 

Department of Health Therapeutic Goods Administration
621057
Online Education
2h : 0m
MBA - CPD: 2h : 0m
RACGP: 4 pts
ACRRM - Fellow: 2 pts
ACRRM - Non Fellow: 2h : 0m
Health Services Administration

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