Basics of therapeutic goods regulation
Depending on the product, a therapeutic good can be subject to additional legislation. For more information: see “Other local Australian regulators” under Useful Resources.
- Clinical trials:
- Consumer products:
- Medicines that are also veterinary medicines:
- Financial subsidy for therapeutic goods:
- Medical Devices Benefits Scheme
- Pharmaceutical Benefits Scheme
- Goods that might contain ingredients from threatened or endangered species:
- Substances that are in the Poisons Standard:
- Health practitioners:
- The Regulation of Medical Devices – This gives more definition but is a publication written in 2011, not guidance.
- Application for conformity assessment certificates (medical devices) – This provides detail on the application process. Mainly a lot of links/attachments.