Services | Regulatory Compliance

Complementary & Listed Medicines

(including Primary Sunscreens)

In Australia, the Therapeutic Goods Administration (TGA) regulates complementary medicines such as herbal, vitamin, mineral and nutritional supplements, as well as some sunscreens. These products are classified as therapeutic goods, are regulated as Listed Medicines and are included on the Australian Register of Therapeutic Goods (ARTG). The Therapeutics Goods Act 1989 (The Act) requires that all therapeutic goods that are imported or manufactured for supply in Australia be included in the ARTG. At the time of submitting an application with the TGA, businesses are required to certify that the medicine meets certain criteria for ingredients, dosage form, evidence, indications, side effects and warning statements.

 

Allure Wellness Consulting can support your business with ensuring all requirements and obligations for a compliant listed medicine are met.

 

Are you looking for help to bring to market a complementary medicine, herbal, vitamin, mineral or nutritional supplement, or sunscreen, in Australia? We can help you with:

  • Product development
  • Ingredient and product formulation reviews
  • Advice on formulation and requirements for Primary Sunscreens
  • Product specifications reviews
  • Preparation and submission of TGA listing applications
  • Stability advice and protocol development
  • Manufacturer liaise and recommendations
  • Product claims / therapeutic indications reviews and evidence packages
  • Label content development and reviews
  • Advertising compliance reviews including review of product promotional material such as labels, packaging, brochures, display stands and websites.
  • Import and export rules and regulations for therapeutic goods
  • GMP Clearances for overseas manufacturers
  • Product formulation reviews for advice compliance with exit/entry markets
  • Response to TGA Section 31 post market reviews
  • Liaising with the TGA

 

Cosmetics & Beauty

Cosmetics in Australia are regulated by the Australia Industrial Chemical Introduction Scheme (AICIS). If you are looking to sell your cosmetic product into Australia, you will need to ensure its ingredients comply with Australian cosmetic regulations. Cosmetic products in Australia must also comply with the NICNAS Cosmetics Guidelines set out by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and be labelled in accordance with Trade Practices – Consumer Product Information Standards. Sometimes, a cosmetic product can be considered a Therapeutic Good if a therapeutic claim is made, further requiring the product to be listed or registered on the Australian Register of Therapeutic Goods (ARTG).

 

Allure Wellness Consulting can help you bring to market Cosmetic products for sale and supply in Australia. We have the expertise to review formulations and labels, for compliance with the relevant regulations.

 

Are you looking for help to bring to bring to market a cosmetic product in Australia? We can help you with:

  • Product development
  • Ingredient and product formulation reviews
  • Product specifications reviews
  • Label development and reviews
  • Advertising compliance reviews
  • Advice on formulation and requirements for Secondary Sunscreens
  • Import compliance advice for established cosmetic products

 

Foods & Beverages

All food products that are manufactured or imported and sold in Australia and New Zealand must comply with the food standards code set by Food Standards Australia New Zealand (FSANZ). The Code is enforced by state and territory departments, agencies and local councils in Australia and the Ministry for Primary Industries in New Zealand.

 

Allure Wellness Consulting can provide your business with advice on product development and food marketing compliance and can assist you to formulate your products to maximise your claims and competitive advantage. We can also support the development of your food product to comply with the specific standards of the Foods Standards Code, including Formulated Meal Replacements, Formulated Supplementary Sports Foods, Infant Formula, and specific types of Beverages.

 

Are you looking for help to bring to market a food or beverage product in Australia? We can help you with:

  • Product development
  • Ingredient and product formulation reviews
  • Product specifications reviews
  • Food label content development and reviews
  • Nutritional Information Panel development to Code standards
  • Nutrition, health & related claims
  • Advertising compliance reviews including review of product promotional material such as labels, packaging, brochures, display stands and websites.
  • Import Permits
  • Manufacturer liaise and recommendations
  • Liaising with FSANZ