Engel Hellyer & Partners is one of the most trusted and experienced Pharmaceutical TGA and AICIS Regulatory Affairs consultants.

Since 1982, we have been providing quality regulatory advice to large multinationals and SMEs.

Regulated in Australia as medicines by the Australian Therapeutic Goods Administration (TGA), complementary medicines include vitamins, mineral and nutritional supplements, homeopathic, aromatherapy products and herbal medicines. The term ‘complementary medicines’ also comprises traditional medicines, including traditional Chinese medicines, Ayurvedic, Australian Indigenous and Western herbal medicines.

These products are often called ‘dietary supplements’ or ‘food supplements’ in other countries where the requirements for manufacturing standards are mostly not as stringent as the pharmaceutical level of manufacturing quality that is mandatory for medicinal products that are supplied in Australia

Complementary medicines require an application to be entered onto the Australian Register of Therapeutic Goods (ARTG) before they can be imported, exported, manufactured, or supplied to consumers.

The TGA will not accept your application if your overseas manufacturer does not meet Australia’s Standard of Good Manufacturing Practice (GMP). Complementary medicines must be manufactured to medicinal standards in TGA approved and licensed facilities. If your manufacturer cannot provide suitable evidence of GMP, the products cannot be supplied in Australia. Complementary medicines may be registered (higher risk) or listed (lower risk) and an approved product label will have a corresponding AUST(R) or AUST(L) number.

Other requirements for complementary medicines include:

  • Must have a sponsor who is responsible for applying to the TGA and is a resident of Australia or be a company in Australia where the representative is residing in Australia.
  • Contain only ingredients that have been assessed as safe by the TGA;
  • Health benefit claims must have evidence and listed medicine claims are limited to TGA permitted indications;
  • Labels must be in English and meet Australia’s standard for medicines labelling;
  • All advertisements, including but not limited to labeling, print, broadcast and mainstream media comply with the Therapeutic Goods Advertising Code (TGAC).

Do you need advice on importing and marketing complimentary medicines in Australia?
Engel Hellyer & Partners can help. We work with you on a customised solution to meet your specific needs ensuring your products meet the relevant guidelines. Upon appointment by the sponsor, Engel Hellyer & Partners can serve as the sponsor’s Client Representative or Agent. As the Client Representative or Agent, we are able to provide a complete application service and to represent the sponsor in consultations with the TGA throughout the evaluation process.