In Australia, the Therapeutic Goods Administration (TGA) regulates therapeutic products; including medical devices, and prescription and OTC medicines including complementary medicines (for example herbs, vitamins and nutritional supplements).
'Dietary Supplements' are recognised and regulated in Australia as 'Complementary Medicines' and as such, medical/therapeutic claims can be made for them. The therapeutic claims must be backed up by suitable evidence. The stronger the claims made, the stronger the evidence must be.
Before any medicine can be supplied in Australia it must be entered on the Australian Register of Therapeutic Goods (ARTG) by the TGA (www.tga.gov.au) and issued with a unique AUST L or AUST R number which then must appear on the label.
What we can do for you:
- Formula reviews for compliance
- Eligibility of products and level of registration required
- Marketing requirements
- Compliance of promotional material across all platforms, including labels, packaging, brochures, display stands, websites, radio, television and social media
- Applications for advertising clearance
- Assistance with technical writing
- Review the evidence you hold to support your product claims
- Correspondence with government agencies
Stability and GMP requirements
- Development of product specifications
- Design protocols for stability trials
- Advice on GMP contract agreements
- Assistance with TGA GMP audits for overseas manufacturers
Therapeutic Goods Administration liaison
- Preparation and submission of applications to TGA (and other Australian Government agencies)
- Assistance with post-market product audits
- Advice on potential impact of draft legislation