TGA listing of Complementary Medicines
In Australia, complementary medicines include vitamin, mineral, herbal, aromatherapy and homoeopathic products.
Products that may be considered to be food supplements or nutritional supplements in other countries are deemed to be complementary medicines in Australia. Multi-vitamin tablets are one such example.
For TGA approval, all complementary medicines must have documentation to demonstrate that:
- they are manufactured to TGA pharmaceutical quality standards
- the ingredients are approved for use in Australia for the proposed dosage form and claims
- the complementary medicine achieves the therapeutic claims
The TGA prefer the documentation to be in Common Technical Document (CTD) format to support the application.
The TGA assesses complementary medicines according to levels of risk. For approval to market the product in Australia:
- Low risk medicines are listed and are assessed for safety and quality
- High-risk medicines must be registered and are assessed for safety, quality, and efficacy.
PharmOut can help you with:
- Regulatory strategy for complementary medicines
- Technical writing, including Common Technical Document (CTD) preparation
- Product development: to integrate regulatory compliance from day 1
- Clinical trials: documentation requirements, preparation and submission of applications
- Registration of complementary medicines: requirements, gap analysis and submission of the application to the TGA
- Post-registration compliance
For further information, read our regulatory white papers, or Contact us.