Regulatory requirements for Australia:Medicines, Cosmetics, Household Cleaning and Food Products

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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)

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Regulation of medicines in Australia

• Prescription medicines: require Doctor’s prescription• Non-prescription medicines

• Over the counter (OTC) medicines

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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

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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

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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

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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 restrictionSome registered OTC medicines and prescription medicines may only be sold through a pharmacy – with pharmacist advice

Regulation of medicines in Australia

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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)

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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

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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

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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

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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

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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

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Australian Quarantine and Inspection Service (AQIS)

Importing Products into Australia

Therapeutic Good• Compliance with Therapeutic

Goods Act• Ingredients• Labelling• Claims • Manufacturing

Foods • Compliance with Food

Standards Code• Category of food• Ingredients• Labelling• ManufacturingAQIS

Compliance OR Non-compliance Goods may be relabelled Orreturned to port of origin Or destroyed

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Contact RFA Regulatory Affairs

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Kerry MartinRegulatory Affairs ManagerE:   RFAinfo@RFAregulatoryaffairs.com P:   +61 2 9660 8027

www.RFAregulatoryaffairs.com