Regulation of personal health care and beauty products in Australia
Products intended for use in or on the body generally fall into one of the following 3 quite distinct regulatory categories:
- Cosmetics, and various household products (“industrial chemicals”)
- Therapeutic products – i.e. medical devices and medicines (including complementary, OTC and prescription medicines).
Note: in Australia, “dietary supplements” are regulated as complementary medicines.
Some brief notes on the issues companies exporting products to Australia will need to address.
Cosmetic products do not have to be submitted to any government agency before you supply them; however there are compliance issues such as
- Registration – as an importer of cosmetics (“industrial chemicals”) your local company must register their company details with federal authorities, a simple procedure that requires an annual fee. Refer to http://www.nicnas.gov.au/Industry/Registration.asp
- Ingredients: must be acceptable for a cosmetic product, they must be included in the Australian Inventory of Chemical Substances (unless exemption is sought), they must comply with restrictions if subject to a poisons schedule, and there may also be quarantine or other import issues to be addressed
- Labelling: the product must have appropriate cosmetic labelling
- Claims: must be cosmetic claims only. You cannot make a therapeutic claim for a cosmetic or it may be classified as an illegal medicine. All medicines require registration with the TGA unless excluded or exempt.
- Weights and Measures and Import and Commerce regulations apply to labelling and packaging
Cosmetics regulations are enforced by Australia’s 8 State and Territory governments.
Foods do not have to be submitted to any government agency for approval before supply. However the product must comply with relevant standards of the Australia and New Zealand Food Standards Code, which includes standards for ingredients, labelling and packaging, contaminants and claims. Food Standards for both Australia and New Zealand are determined by Food Standards Australia New Zealand (FSANZ). In New Zealand, the standards are regulated by the national government. In Australia, the standards are enforced by the State and Territory governments.
State and Territory governments do a poor job of policing food regulations, but for a company exporting to Australia you must also pass through inspections by customs and quarantine authorities, and they may hold up shipments of goods if they perceive them to non-compliant.
It is important to realise that there may be quarantine issues that need to be addressed prior to importation, as some ingredients require an Import Permit (for example some dairy and animal products).
Complementary medicines include vitamin/nutrient supplements, herbal remedies and similar products such as homoeopathic medicines and aromatherapy. Important considerations:
- GMP - all complementary medicines supplied in Australia must be manufactured in a facility that has been audited for compliance with pharmaceutical GMP. The Australian Code is based entirely on the international standard Guide to Good Manufacturing Practices for Medicinal Products, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). GMP accreditation is specific to the type of dose form audited (e.g. tablets, capsules, liquids, etc) and the steps in manufacture that are undertaken. Refer to the TGA guidelines for overseas manufacturers: http://www.tga.gov.au/manuf/gmpsom.pdf.
- Ingredients - most complementary medicines are “listed” on the Australian Register of Therapeutic Goods. This is a lower level of registration than “registered” medicines. The ingredients must be included in the pre-approved list of active and non-active ingredients. There may be quarantine issues that need to be addressed prior to importation, as some ingredients require an Import Permit (for example some animal products).
- Claims - the sponsor of the product must hold evidence to support the product claims. The TGA guidelines are at http://www.tga.gov.au/docs/pdf/tgaccevi.pdf. General and medium level therapeutic claims may be made for listed complementary medicines and high level claims may be made for registered complementary medicines.
- Labels - the product must be labelled in compliance with Australian guidelines: http://www.tga.gov.au/docs/html/tgo/tgo69_1.htm. The AUST L number issued by the TGA must be printed on the product label.
- Application costs - the TGA application fee for a listed medicine is $640 (per product) and there is an annual charge of $810 per product. The TGA takes around 5 days to process the application.
Complementary medicine regulations are enforced by the national government agency the Therapeutic Goods Administration (TGA).
(Robert Forbes is Director of Robert Forbes and Associates, a leading regulatory consultancy in Australia www.robert-forbes.com)