Summary classification of medicines

November 2005

This document is intended as a guide only. Reference must be made to the Regulations and Orders made under the Act.

Medicines are defined as:

1. therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal; and
2. any other therapeutic goods declared by the Secretary, by a notice published in the Gazette, not to be medical devices.

Registrable (Aust R) goods

(Based on Schedule 3 of the Therapeutic Goods Regulations <http://www.tga.gov.au/legis/index.htm>)

• All Pharmaceutical Benefit medicines
• All other medicines unless Listable or exempt (see lists below)

Listable (Aust L) goods

(Based on Schedule 4 of the Regulations, and Parts 1 and 2 of Appendix 6 to the Therapeutic Goods Advertising Code <http://www.tga.gov.au/advert/tgac.htm>)

Exports

All goods that are manufactured in Australia for export only, or imported into Australia for export only and are listable only because they are so manufactured or imported. These medicines exclude the medicines exempt under Schedule 5 of the Therapeutic Goods Regulations (See list below).

Medicines

• Vitamin, mineral, herbal and similar (Part 5) products in any combination if not scheduled (in the SUSDP) and not sterile and with no unacceptable claims under the Advertising Code and if containing only specified vitamins (Part 2), specified minerals (Part 3) or already listed or registered herbals (but not those in Part 4 Division 1), with some other qualifications as noted in Item 3.
• Homoeopathic preparations being:
  • mother tinctures
  • dilutions of 1000 fold or less, if non-sterile, if non-scheduled (unless due to a component at more than 1000 fold) and if not containing a Part 4 herb at 1000 fold or lesser dilution
  • dilutions of more than 1000 fold if non-sterile and with unacceptable claims
• Medicated throat lozenges (volatile oils, vitamin C) with no unacceptable claims
• Sunscreens SPF4+ if correctly labelled; or SPF4 or less if containing human or certain animal tissue
• Uncompounded, unscheduled British Pharmacopoeia (BP) medicines with acceptable claims
• Medicated space sprays (only volatile oils)
• Amino acids (with exceptions, see list) alone or with other substances if not scheduled, not sterile, not subject to (Aust R) registration and having no unacceptable claims
• Medicine kits if any component is subject to registration or listing

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Exempt from registration or listing

(Based on Schedules 5 and 5A of the Therapeutic Goods Regulations <http://www.tga.gov.au/legis/index.htm>)

Imports, exports, samples, institutional and custom-made

• Personal-use imports (unless prohibited) (exceptions apply) for 3 month use (limits apply) and with a prescription if S4 or S8 (in the SUSDP)(unless travelling)
• Imports held in bond for export, or awaiting certain permit or approvals, or for clinical trails (conditions apply)
• Imports for visiting groups (conditions apply)
• Non-commercial exports, unless for clinical trials or prohibited
• Goods made specially by a licensee for a hospital or institution where there are no similar registered/listed goods available, or made specially for a patient
• Samples not for use in humans
• Extemporaneous (one-off) medicines

Medicines

(in general, not if a claim is prohibited for general sale and not if containing human or certain animal tissue):

• Starting materials, but not if pre-packed for sale or in dosage form
• Blood and blood components made by the Red Cross
• Non-sterile, dilute (4X) homoeopathics
• Antiperspirants if A1, Zn, Zr salts
• Anti-acne cleansers
• Anti-dandruff products if unscheduled
• Medicated insect repellants if unscheduled
• Sunscreens below SPF4 if correctly labelled
• Allergen patch tests
• Radiopharmaceutical 'cold kits' made in hospitals (conditions apply)
• "Non-critical" disinfectants (see detail)
• Medicines permitted to be imported before commencement of the Act (2/91)

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Declared not to be therapeutic goods

(Based on Excluded Goods Order No. 1 of 2004) (revoked by Therapeutic Goods (Excluded Goods) Order No. 1 of 2005 on 9 November 2005) <http://www.tga.gov.au/legis/tgeg0501.htm>

• Spa and natural mineral waters with no claims
• Unmedicated soap and detergents for cleansing the skin or hair
• Creams, lotions, etc. for cleansing, moisturising, softening, protecting from irritation but not as barriers to water or infection and not for dispensing use
• Deodorants and depilatories for use on the skin
• Hair bleaches, hair dyes, hair-colourants and hair perming preparations
• Nail hardeners and nail biting deterrents
• Preparations incidentally containing sunscreens (see details)
• Oral hygiene products (including unmedicated chewing gum) with no other claims, including toothpaste claiming only prevention of decay but excluding Scheduled products such as high-fluoride toothpaste
• Dental bleaches or whiteners
• Denture adhesives, cushions, repair aids, if for retail sale

Declared to be medicines

(Based on Therapeutic Goods (goods not devices) Orders <http://www.tga.gov.au/legis/devices.htm> and Order that Goods are Therapeutic Goods No. 1 of 1999 <http://www.tga.gov.au/legis/ogto9901.htm>)

• Blood components, substitutes and expanders but not if coated onto devices
• Contraceptives, intrauterine, containing hormones; sponges, membranes etc. that deliver spermicide or virucide
• Demulcents and adsorbents, ingested
• Diagnostics, in vivo, including imaging agents
• Dialysis solutions and chemicals
• Disinfectants and antiseptics, if not in devices or for contact lenses
• Emollient/moisturising products for dispensing
• Enemas, douches, laxatives and irrigation fluids, unmedicated
• Homoeopathic preparations
• Medical gases and chemical oxygen generators
• Saline and water for injection
• Spermicidal and virucidal sponges and membranes
• Sunscreens
• Transdermal patches
• Products containing fibre in capsule, tablet or pill form
• Antiseptic wipes for use on human skin;
• Paper tissue with antiseptic and/or viricide for use on human skin.
• Absorbable haemostatic agents (fibrin)
• Body 'cleaning' substances including bulk and salt solution laxatives, enema solutions, medicated mouthwashes and activated charcoal used internally
• Body fluid replacements and nutrients including electrolyte solutions, plasma expanders, total parenteral nutrition solutions, blood substitutes, peritoneal dialysis solutions & substances prepacked for their preparation
• Dusting powders with therapeutic uses
• Some pre-filled or pre-loaded devices intended to deliver a medicine (see detail)
• Dissolution agent used with lithotripter
• Allergen skin tests (scratch)

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