Regulatory requirements for Australia: Medicines, Cosmetics, Household Cleaning and Food Products
Overview Regulation of medicines in Australia Regulation of cosmetic and household products in Australia Regulation of food products in Australia Importation: Australian Quarantine and Inspection Service (AQIS)
Regulation of medicines in Australia Prescription medicines: require Doctor s prescription Non-prescription medicines Over the counter (OTC) medicines
Regulation of medicines in Australia Do you need Government approval to sell a medicine in Australia? Therapeutic Goods Administration (TGA) Two classes of medicines Registered medicines: prescription medicines and some non-prescription OTC medicines Listed medicines: complementary (herbal) medicines, vitamins & mineral supplements and sunscreens
Regulation of medicines in Australia Are there any standards for manufacturing? Manufactured by a GMP licensed manufacturer Complies with the Australian Code of Good Manufacturing Practice (GMP) Australian manufacturers: licensed by the TGA Manufacturers outside of Australia: assessed by the TGA for compliance with GMP Australia and Germany - Mutual Recognition Agreement
Regulation of medicines in Australia Are there rules about labelling and advertising medicines? Therapeutic Goods Act / Regulations Competition and Consumer Act (ACCC) Therapeutic Goods Advertising Code (TGAC) Therapeutic Goods Order No. 69 Forms of advertising include: Product label Consumer literature (brochure / pamphlet) Point of sale display Print / radio / TV advertising Cinema / film advertising Billboard Internet
Regulation of medicines in Australia Where are medicines sold in Australia? Retail Pharmacies Health food stores Supermarkets Health practitioners clinics Direct selling Mail order Multi-level marketing Internet Complementary medicines can be sold without restriction Some registered OTC medicines and prescription medicines may only be sold through a pharmacy with pharmacist advice
Regulation of cosmetic and household products in Australia What is a cosmetic? Products applied to any external part of the body, including mucous membranes of the oral cavity and teeth Purpose: to cleanse, maintain the condition, change the appearance, alter body odours, perfume or protect it Examples: skin moisturisers and cleansers, makeup, most toothpastes, hair care products, and deodorants Products that make therapeutic claims e.g. eczema relief, acne treatment or skin healing, fall under the definition of and are regulated as a medicine Primary sunscreens are considered therapeutic goods (listed medicines)
Regulation of cosmetic and household products in Australia What are household products? Household cleaners: soaps and detergents designed for household hygiene Laundry products: designed for fabric cleaning and care Household maintenance products: polishes, waxes and restorers designed to polish, protect or maintain Air-care products: designed to remove unpleasant odours Automotive cleaners: designed to maintain external appearance / interior comfort of motor vehicles
Regulation of cosmetic and household products in Australia Importers and manufacturers must register their business with National Chemicals Notification and Assessment Scheme (NICNAS) No pre-approval / application for cosmetics and household cleaning products before supply Ingredients must be included on the Australian Inventory of Chemical Substances (AICS) No specific code governs manufacture Product labels and advertising cannot make therapeutic or medical claims No pre-approval for advertising Sold via retail outlets, wholesale, online and direct selling
Regulation of food products in Australia Categories of foods described in the Australia and New Zealand Food Standards Code Food or medicine? Some nutritional products may be presented as foods: Formulated Meal Replacement Formulated Supplementary Food Formulated Supplementary Sports Food Special purpose foods Most nutritional supplements and herbal products are classified as complementary medicines
Regulation of food products in Australia No pre-approval / application for food products before supply Food products must comply with Food Standards Code which outlines: most permitted and restricted ingredients basic manufacturing requirements product label requirements requirements for claims made about food products - no treatment / prevention of disease Requirements of the Food Standards Code are enforced by each state/territory in Australia Shipments may be inspected by AQIS at port of entry for compliance No pre-approval for advertising No restriction on sale of foods - retail outlets and direct selling FSANZ : http://www.foodstandards.gov.au
Australian Quarantine and Inspection Service (AQIS) AQIS provides quarantine inspection services for a range of animal and plant products imported into and exported from Australia Most products derived from animals, plants and micro-organisms (including the micro-organisms themselves) require an import permit Products may include foods, unprocessed dried herbal medicines, agricultural materials and ingredients for cosmetic manufacture ICON is an AQIS database that lists Australian import conditions for more than 20,000 foreign plant, animal, mineral and human commodities
Australian Quarantine and Inspection Service (AQIS) Importing Products into Australia Therapeutic Good Compliance with Therapeutic Goods Act Ingredients Labelling Claims Manufacturing AQIS Foods Compliance with Food Standards Code Category of food Ingredients Labelling Manufacturing Compliance OR Non-compliance Goods may be relabelled Or returned to port of origin Or destroyed
Contact RFA Regulatory Affairs Kerry Martin Regulatory Affairs Manager E: RFAinfo@RFAregulatoryaffairs.com P: +61 2 9660 8027 www.rfaregulatoryaffairs.com