Food Supplements
Expanding your food supplement business from Europe to Australia requires comprehensive understanding of local regulatory requirements and compliance standards. Australia operates under the jurisdiction of Therapeutic Goods Administration (TGA), which sets stringent guidelines for product formulation, labelling, health claims, and safety documentation.
At Taylored Consultancy, we specialise in supporting Europe-based food supplement companies navigating the Australia regulatory landscape. Our end-to-end compliance services ensure your products meet all necessary requirements for successful market entry, from formulation review and labelling compliance to Food Business Operator (FBO) registration and ongoing regulatory support.
Comprehensive assessment under Therapeutic Goods Act 1989 to determine if product is a Listed Medicine (AUST L) or Registered Medicine (AUST R) for ARTG entry requirements.
Complete Australian Register of Therapeutic Goods registration process, including formulation review, evidence compilation, and TGA submission for market approval in Australia.
Full compliance review under Therapeutic Goods Advertising Code, ensuring permitted indications for listed medicines and all labelling meets TGA requirements for Australia.
TGA sponsor requirements assessment and application support, including manufacturing evidence, GMP compliance verification, and sponsor licensing for Australia market entry.
Compilation of traditional use evidence or scientific substantiation, supporting documentation for claims, and all required technical data for TGA assessment and approval.
Post-market surveillance, adverse event reporting systems, continuous monitoring of TGA regulatory updates, and compliance maintenance for Australia market authorization.
