Other resources for sponsors of listed medicines and registered complementary medicines

Videos

• A summary of supplying therapeutic goods in Australia
• Basics of therapeutic goods regulation 

Decision tree/tools

• Is my product a therapeutic good?
  A tool for businesses to identify whether their product is a therapeutic good, and if so, the type of therapeutic good that it is likely to be.
• Section 7 declarations – food or therapeutic good?
  Declarations by the Secretary that certain products are therapeutic goods.
• Pathways for complementary medicine products
  A tool for potential sponsors of complementary medicines to determine the most suitable pathway to enter their product in the Australian Register of Therapeutic Goods (ARTG).
• Information sources that could assist regulators with market authorisation of complementary/herbal medicine ingredients
  Resource on the regulatory framework of herbal and other complementary medicine ingredients in a number of regulatory agencies
• What do I require to have a listed medicine in the ARTG?

Fact sheets and FAQs

• Folate and folic acid for use in listed medicines (fact sheet)
• Criteria for permitted indications fact sheet.
• Using permitted indications
• Principles for terminology used in permitted indications (fact sheet)
• Frequently asked questions raised by industry in relation to permitted indications.
• Assessed listed medicines pathway: frequently asked questions

E-learning modules for sponsors

• Evidence requirements for listed medicines
  A supplement to the Evidence guidelines for listed medicines to help sponsors determine if a piece of evidence is suitable for inclusion as part of an evidence package for listed medicines.
• Overview of permitted indications and transition arrangements
  Information for sponsors of medicines listed before 6 March 2018 on transitioning to permitted indications
• How to remove indications and add permitted indications for your existing medicine on the TGA Business Services portal
  A demonstration on changing indications for a listed medicine through the TGA Business Services (TBS) portal
• Selecting parent indications and linking indications on the TGA Business Services portal
  A demonstration on linking symptom indications to 'parent' indications in TBS listed medicine applications.

Webinar recordings

• SME Assist - Permitted indications for listed medicines, March 2019
  A presentation on the requirements for permitted indication directed to small to medium enterprises.