1.12. Compliance Obligations for Listed Complementary Medicines

The perfect course for companies wanting to export to Australia who may have products classified as “dietary supplements” in their own country, who will need to become familiar with Australia’s regulations for complementary medicines. Also useful for newcomers or cosmetic and food brands expanding into this category. Includes guidance on ingredients, claims, labelling, manufacturing standards and ongoing compliance after the product is on the market.

This course teaches you:

• Regulatory framework
• Formula and claims are publicly visible
• Register with TGA as a sponsor, authorise an agent(s)
• Manufacturing
• Ingredients
• Therapeutic indications and product claims
• Evidence to substantiate therapeutic indications
• Pharmacovigilance
• Stability testing
• Labelling and advertising
• TGA Fees
• Prerequisites for ARTG listing
• Dossier for listed medicines
• Ongoing compliance of ARTG listings
• TGA compliance monitoring

Duration: 3 hrs