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Other resources for sponsors of listed medicines and registered complementary medicines
- 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.
- SME Assist - Permitted indications for listed medicines, March 2019
A presentation on the requirements for permitted indication directed to small to medium enterprises.