Food Supplements Registration in Australia - Overview
The Australian food and complementary medicine market is an established yet dynamic market that focuses 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’s health portfolio and is responsible for developing food standards for Australia. By gaining food product registration FSANZ approval, food manufacturers demonstrate their commitment to complying with the food safety standards, instilling confidence in consumers, and facilitating market access for their innovative and safe food products.
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 the Food Standards Code. Food importers are responsible for ensuring that all the food they import complies with the relevant standards code, as they seek to obtain food product registration with FSANZ approval.
In Australia, the Therapeutic Goods Administration (TGA) regulates complementary medicines. These consist of traditional herbal medicines, nutritional supplements, vitamins and minerals, Homoeopathic (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 product registration FSANZ, novel food registration, label and claims review, ingredient analysis, and complementary medicine registration and application, along with GMP compliance and local sponsorship.
Food Supplements Registration in Australia - 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 Nutritional Information Requirements.
Food Supplements Registration in Australia - 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 for 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.