Food and Food Supplements Regulatory Services in Australia

Food and Complementary Medicines
Regulatory Services in Australia


The Australian food and complementary medicines market is an established yet dynamic market, focusing on product differentiation as their key growth strategy. The market consists of intensively innovative product lines that are supported by the rich biodiversity of the region. Food Standards Australia New Zealand (FSANZ) is the statutory authority in the Australian government health portfolio, and it is responsible for developing food standards for Australia and New Zealand. 

The Australia New Zealand Food Standards Code contains several standards that lay out requirements for foods sold in Australia and New Zealand. Foods imported into Australia must comply with strict biosecurity requirements and with the Food Standards Code. Food importers are responsible for ensuring that all the food that they import complies with the relevant standards given in the Code. 

In Australia, the Therapeutic Goods Administration (TGA) regulates complementary medicines. These consist of traditional herbal medicines, nutritional supplements, vitamins and minerals, Homeopathic (diluted) preparations, Aromatherapy preparations, including essential oils, traditional Chinese medicines, Ayurvedic (traditional Indian) medicines, etc. Complementary medicines require mandatory registration with the TGA, depending on the product categorization, along with Good Manufacturing Practices (GMP) compliance and local sponsorship. Complementary medicines must be included in the Australian Register of Therapeutic Goods (ARTG) and are differentiated by the AUST L or AUST R number on the labels.

Freyr provides professional assistance for compliance with food and complementary medicine products, novel food registration, label and claims review, ingredient analysis, and complementary medicine application along with GMP compliance and local sponsorship.


Freyr Expertise

  • Food Product Compliance
  • Complementary Medicine Product Classification
  • Formula Review/Ingredients Assessment
  • Label and Claims Review
  • Claims Consultation and Substantiation
  • Regulatory Marketing Strategy and Regulatory Intelligence Report
  • Periodic Updates on Product-specific Regulatory Guidelines/Standards
  • Novel Food Enquiry Submission
  • Novel Food Registration
  • Import Guidance
  • Regulatory Advice for Complementary Medicines
  • Product Listing in the ARTG or Product’s Recipient Change Post the Listing
  • GMP Assistance Services
  • Sponsor Services for Complementary Medicines
  • Review or Preparation of Nutrition Information Requirements
Freyr Advantages


Freyr Advantages


End-to-end Regulatory consultation on requirements of food product classification, compliance, registration, and market launch


A qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, Health Functional Foods (HFFs), health functional beverages, Foods for Special Dietary Use (FSDU), etc.


Support in region-specific Regulatory activities


A strong relationship with different Health Authorities (HAs) viz. FSANZ and TGA, and an extensive partnership network across the globe


Assistance in providing sponsor services or local representation in Australia