Legislation
The Act and Regulations
Control of Therapeutic Goods
Supply
Standards
Listed Goods
Evaluation of Therapeutic Goods
Product Classification
Contact the Therapeutic Goods Administration
Understanding Product Labels

Legislation
The Therapeutic Goods Act 1989 provides for national control over therapeutic goods. It is in addition to any other legislation, which may relate to therapeutic goods. The State Poisons legislation's, SUSDP (Standard for the Uniform Scheduling of Drugs & Poisons), the Customs Act 1901, the Customs (Prohibited Imports) Regulations (CPI reg.'s) are some of the other controls governing therapeutic goods. The promotion of therapeutic goods is also subject to the general provisions of the State Fair Trading legislation and the Federal Trade Practice Act. In some circumstances door to door selling legislation.

The Act and Regulations
The Therapeutic Goods Act 1989 provides the basis for the controls while the Therapeutic Goods Regulations indicate how these controls are to be enforced. The object of the Act is "to provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods used in Australia or manufactured and exported from Australia."

These controls are enforced through:-

• The determination of standards
• Restricting the supply of therapeutic goods
• Controls for the experimental use of therapeutic goods
• Requirement that the goods be manufactured according to a suitable standard of manufacture
• Data to be evaluated as part of registration/ listing
• Evaluation time and fees
• Conditions on registration and listing
• Monitoring of compliance with the Act

The "Therapeutic Goods Regulations, 1989" is a dynamic document and like all regulations is constantly being amended to make allowances for new definitions and or classes of therapeutic goods and how they should be controlled.

Control of Therapeutic Goods
The Therapeutic Goods Act (TGA) controls drugs and devices in terms of:-

• Supply
• Standards
• Advertising
• Presentation

Supply
The Act states that it is an offence to supply a therapeutic good in Australia unless it is listed on the ARTG (Australian Register of Therapeutic Goods). The ARTG is a register of all therapeutic goods supplied in Australia. All goods entered on the ARTG must display their registration (AUST R) or listing (AUST L) number on the front panel of the outer label.

Standards
The ACT sets the standards of:-

• Ingredients used in therapeutic goods
• Finished products
• Presentation
• Advertising
• Manufacture

Standards - Ingredients
Most ingredients are expected to meet BP93 standards where a monograph is available. Where no BP93 monograph is available, the TGA have designated the appropriate monographs to which the ingredients must comply. These references may be found in the list of AAN's (Australian Approved Names).

Standards - Presentation/Labelling
The main requirements are:-

• Active ingredients must be declared on the main label.
• Contents must be in metric units
• Quantity of ingredients must be declared in terms of unit dose for solid dosage forms and unit volume in terms of liquids
• Certain excipients must be declared on label
• Batch number and expiry date must be present and prefaced by approved prefixes.
• Storage directions must be one of those approved
• Directions for used must distinguish between adults and children. Children's age must be specified.
• Australian sponsor's name and address MUST appear on the label.

Standards - Advertising
The Therapeutic Goods Advertising Code provides a list of words and claims that are unacceptable for use on therapeutic goods. It also provides a list of acceptable words for certain indications and circumstances, where additional warnings must be added to a label to make a claim eligible.

Standards - Manufacture
All therapeutic goods (drugs) must be manufactured according to a suitable standard GMP. If manufactured overseas, they must be manufactured according to a therapeutic license recognised by the following countries; Australia, EC, NZ, Canada, USA-FDA, Japan, Sweden.

Listed Goods
In general, listable drugs are:-

• Non-scheduled poisons
• Vitamins and Minerals as determined by the regulations
• Herbal ingredients not excluded by the regulations and poisons schedules
• Sunscreens with SPF factor of 4 or more
• Amino Acids except those specified
• Finite list of special ingredients: pectin, bioflavonoids, fish oil, oyster shell, propolis, fructose, glucose and others
• Homeopathic drugs of dilution 1000 or less with non-prohibited claims
• Homeopathic drugs of dilution greater than 1000 with prohibited claims

Understanding Product Labels
When you buy prescription or over-the-counter medicines, a sunscreen or a vitamin supplement, it is crucial that you have certain information to help you make an informed purchase.

The label tells you what you are buying, what it can do for you and how to use it to get the best results. It provides important information about storage conditions and the expiry date.

Labelling is part of the national system of regulating medicines. Most of these products must be included in the Australian Register of Therapeutic Goods, with a small number exempt.

What do the Aust R and Aust L numbers mean?
They show that the medicines are accepted by the Therapeutic Goods Administration for supply in Australia and are included in the Register. The number is printed on the outer packaging so that it can be seen easily.

AUST R medicines are assessed for safety, quality and effectiveness. They include all prescription only medicines and many over-the-counter products such as those for pain relief, coughs and colds and antiseptic creams.

Prescription only medicines do not display their purpose on the label as the decision for using them lies with a doctor; however, over-the-counter medicines must have a purpose displayed.

AUST L medicines are much lower risk self-medication products. They are used for minor health problems and are reviewed for safety and quality. They include sunscreens over SPF4 and many vitamin, mineral, herbal and homoeopathic products. A purpose must be included on the label.

What about other Key Information?
Other important information relating to the quality and safe use of the product must be on container labels and the outer packaging. You should read this information and closely follow any directions. This information includes:

STORAGE CONDITIONS - labels must show how to store the product such as "Store below 30°C" which in most parts of Australia means room temperature. Some medicines must be stored in a refrigerator.

EXPIRY DATE - this is similar to the use-by date on food products at the supermarket. The medicine should not be used after this date because it can lose its effectiveness or become unsafe.

BATCH NUMBER & COMPANY NAME & ADDRESS - the batch number and name and address of the supplier must be on the labels and can be used to trace the medicine if a problem is found.

Always read the labels on medicines
aCheck to see if there is an AUST R or AUST L number.
aUnless a doctor has prescribed it, check the medicine's uses to make sure they are
   suitable for your needs.
aRead carefully all directions and warnings, and always follow them.
aCheck the storage conditions including the recommended temperature.
aCheck the expiry date. When the date is reached, safely dispose of any remaining
   medicine.
aSee if the batch number and supplier's name and address are visible.

Evaluation of Therapeutic Goods
The TGA (Therapeutic Goods Administration) carries out the evaluation of therapeutic goods. The Therapeutic Goods Administration (TGA) is a division of the Department of Human Services and Health (DHSH).

Product Classification
In Australia, products are sold as either Foods, Cosmetics or Therapeutic Goods. Definitions of these terms are as follows:

1. Foods - For example, FibreNet Plus
   "Food means those goods which, in the form in which they are presented, have an established use for nourishment, hydration, to satisfy hunger or thirst, or to satisfy a desire for taste or flavour or texture and which do not have a recommended dosage regime".
2. Cosmetics - For example, Shampoos, Oral Healthcare
   A cosmetic product is a substance or preparation intended for placement in contact with any external part of the human body, including the mucous membrane of the oral cavity, and the teeth with a view to:
• Altering the odours of the body; or
• Changing its appearance; or
• Cleansing it; or
• Maintaining it in good condition; or
• Perfuming it; or
• Protecting it.

In other words, a cosmetic helps the body look or smell good. It does not change the body - just the appearance and odour.

3. Therapeutic Goods - For example, LifePak
   Goods that are represented in any way to be, or that are; whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
• for therapeutic use; or
• for use as an ingredients or component in the manufacturer of therapeutic goods; or
• For use as a container or part of a container for goods stated above.

By "therapeutic' use we mean:

• preventing, diagnosing, curing or alleviating a disease, defect of injury in persons or animals,
• influencing; inhibiting or modifying a physiological process in persons or animals If its looks like, acts like or is claimed to be therapeutic good then it is.

Therapeutic Goods Administration
Postal Address:
PO Box 100
Woden ACT 2606,
Australia

Sources:

• Food Standards Code, 1998.
• Cosmetic Claims Guidelines, 1994.
• Code of Conduct, CTFAA.
• Trade Practices (Consumer Product Information Standards (Cosmetics) Regulations.
• Therapeutic Goods Act, 1989.
• Therapeutic Goods Regulations, 1989.