This White Paper offer practical advice on “How to list or register a complementary medicine in Australia”, complementary medicines include vitamin, mineral, herbal, aromatherapy and homeopathic 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. This white paper provides an outline of how to tell if your product is classified as a complementary medicine and describes the system and processes for regulatory approval to supply these medicines in Australia.

Purpose

This white paper provides an outline of how to tell if your product is classified as a complementary medicine and the legal and regulatory requirements and processes for obtaining approval to supply complementary medicines in Australia. It outlines the steps for meeting the TGA requirements for manufacture and supply of the products and provides practical tips on which path to follow, the timelines and costs involved.

Audience

This White Paper is written to assist anyone interested in the planning and execution of regulatory activities to support supply of complementary products in Australia.