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TGA medicine labelling and packaging review
Glossary of terms
Definitions of key terms used in this consultation paper are provided in this section to facilitate a common understanding of the key issues and proposed regulatory options.
Active ingredient: the ingredient of the medicine that allows the medicine to have an effect in the body.
Ampoule: a small, usually glass, container for liquid medicine preparations.
Australian Register of Therapeutic Goods (ARTG): The publicly accessible reference database of the therapeutic goods available in Australia. It provides information on therapeutic goods that can be supplied in Australia. Products may be registered or listed on the ARTG, depending on the class of therapeutic good. If a therapeutic good is not entered on the ARTG, it cannot be supplied in Australia unless access has been granted under the special access scheme.
The ARTG is available online for anyone to view and includes the following information:
- Product name and ingredients
- Sponsor and manufacturer details
- If a medicine is registered or listed
More information on searching the ARTG can be found at: Searching the Australian Register of Therapeutic Goods (ARTG).
Batch: a quantity of a product that is (a) uniform in composition, method of manufacture and probability of chemical or microbial contamination; and (b) made in one cycle of manufacture and, in the case of a product that is sterilised or freeze dried, sterilised or freeze dried in one cycle.
Blister strip: a sheet of plastic with pockets that contain tablets or capsules, sealed with a thin sheet of aluminium.
Brand name: means the commercial name: (a) given to goods by the manufacturer and (b) under which the goods are supplied. Also known as trade name.
Complementary medicines: also known as 'traditional' or 'alternative' medicines, include vitamin, mineral, herbal, aromatherapy and homoeopathic products. Complementary medicines may be either listed or registered, depending on their ingredients and the therapeutic claims made.
Excipient: An inert or inactive substance used in preparing medicines.
Expiry date: the date (expressed as the month and year) after which the goods should not be used.
Listed medicines: are considered low risk medicines that are evaluated and approved for marketing in Australia based on assessment of safety and manufacturing quality. Medicines that are listed on the ARTG have been assessed against quality and safety, but not efficacy, criteria. This includes most complementary medicines. At the time of listing, sponsors must certify that the medicine meets a range of requirements. In particular, they must certify the medicine is eligible for Listing, that the presentation is not unacceptable, that the medicine is safe for the purposes for which it is to be used, and that information or evidence is held to support any claim made in relation to the medicine. Listed medicines may only make limited therapeutic claims. Listed medicines are not permitted to include substances that are scheduled in the Poisons Standard and can be identified by the presence of an 'AUST L' number on the medicine label.
Look-alike medicine branding: marketing of two or more products under a single brand name. Also known as brand extension or trade name extension.
Non-prescription medicines (aka over-the-counter medicine): medicine that can be purchased without a prescription as follows:
Pharmacist only medicines which are available only from pharmacies with the provision of advice from a pharmacist prior to sale.
Pharmacy only medicines which are available for self-selection within a pharmacy.
General sale medicines which are available in pharmacies, grocery and convenience stores.
Ophthalmic preparation: medicine used in the eye.
Poisons Standard: consists of decisions regarding the classification of medicines and poisons into Schedules (levels of public access) for inclusion in the relevant legislation of the States and Territories.
Prescription medicines: medicine that must be prescribed by a health care professional with prescribing rights.
Registered medicines are evaluated for quality, safety and efficacy prior to being approved for market in Australia. High risk registered products include all prescription medicines and some specified products, such as sterile injectables. Lower risk registered products include non-prescription medicines and some complementary medicines. Products containing substances scheduled in the Poisons Standard are evaluated as registered medicines. Registered medicines can be identified by the presence of an 'AUST R' number on the medicine label.
Stakeholder: a person, group or organisation who affects, or can be affected by, an organisation's actions.
A medicine label is a display of printed information upon, or securely affixed to, the container, any intermediate packaging and primary packaging of a medicine. The components of a medicine label are illustrated in Figure 2: The components of a medicine label.
The container is an item that immediately covers the medicine and includes an ampoule, blister pack, bottle, sachet, dial dispenser pack, strip pack, syringe, tube, vessel, vial, wrapper or other similar item, but does not include an item intended for ingestion.
A primary pack / packaging means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers. For example, the packaging which you see when you look at a medicine on a pharmacy shelf is called primary packaging; this may be just the container, or it may be a cardboard box that contains the bottle or blister packs.
*Images shown are not actual medicines or brands.
Hypothetical medicine box identifying the key elements of a medicine label.