Generally called “complementary medicines,” listed medicines are a subset of therapeutic good in Australia that may only contain pre-approved, low risk ingredients and are limited to low-level health claims. Listed medicines include vitamins, minerals, amino acids, herbs, extracts and more.
In Australia, applications for listed medicines are not reviewed prior to the medicine’s inclusion on the ARTG, but applicants must attest that their product contains only pre-approved ingredients and makes low-level claims. Any therapeutic claims made for the product must be supported by evidence held by the company introducing the product. The benefit of using this approach is an extremely quick approval process and short time to market vital to the growth and stability of any company. The drawback of market authorization via the listed medicine route is the limitations on formula composition and marketing strategies. NHP Consulting can assemble evidence packages for health claim substantiation, and prepare/submit applications for listed medicines to the TGA. We can review promotional materials (labels, packaging, website, radio/TV advertisements) to ensure compliance with Australian advertising regulations (the Therapeutic Goods Advertising Code) and assemble dossiers for the evaluation of new complementary medicine substances (ie. approved ingredients) for listed medicines.
NHP Consulting will provide all regulatory documentation to achieve market compliance for the Australian marketplace.