All | # A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
There are currently 104 names in this directory
[The] Register
Definition: The Australian Register of Therapeutic Goods. As per: TGA

AAN
Definition: Australian approved names, TGA approved terminology for medicines. As per: TGA

ACCC
Definition: Australian Competition and Consumer Commission As per: TGA

Active ingredient
Definition: The therapeutically active component in a medicine's final formulation that is responsible for its physiological action. As per: TGA

Active raw material
Definition: The unformulated active chemical substance, usually a powder or a liquid, in the form in which it is used to manufacture a dosage form, usually in combination with excipient. As per: TGA

Advertisement
Definition: In relation to therapeutic goods as defined in the Therapeutic Goods Act 1989 includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods. As per: TGA

AICS
Definition: Australian Inventory of Chemical Substances As per: TGA

Antiseptic
Definition: A substance: a. That is recommended by its manufacturer for: i. dermal application; or ii. Application to the mucous membranes of a person or an animal: A. to kill micro organisms; or B. To prevent the growth of micro organisms to a level that causes or may cause clinical infection; and b. That is not represented to be suitable for internal use. As per: TGA

AUST L number
Definition: The unique ARTG number for a listed therapeutic product. As per: TGA

AUST R number
Definition: The unique ARTG number for a registered therapeutic product. As per: TGA

Batch
Definition: 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 As per: TGA

BP
Definition: British Pharmacopoeia, the edition of the publication of that name, including any additions or amendments, that was in effect for the purposes of this Act immediately before the commencement of Schedule 4 to the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the British Pharmacopoeia Commission or any replacement body. As per: TGA

Broadcast media
Definition: In relation to an advertisement or generic information, means any means (other than a means declared in the regulations to be an exempted means) by which the information is disseminated electronically in a visible or audible form or a combination of such forms. As per: TGA

Client ID
Definition: Identification code assigned by the TGA to a client. As per: TGA

Clinical trial
Definition: A planned study in humans designed to investigate or report upon the effectiveness and/or safety of a therapeutic good. As per: TGA

Competition and Consumer Act 2010 (CCA)
Definition: The Competition and Consumer Act 2010 (formerly the_Trade Practices Act 1974) deals with almost all aspects of the marketplace: the relationships between suppliers, wholesalers, retailers, competitors and customers. It covers anti-competitive conduct, unfair market practices, industry codes, mergers and acquisitions of companies, product safety, product labelling, price monitoring, and the regulation of industries such as telecommunications, gas, electricity and airports. _ As per: TGA

Complementary medicine
Definition: Means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use. As per: TGA

Composite pack (Medicine)
Definition: A medicinal product where the primary pack or the container includes at least two kinds of medicinal products and does not contain any medical devices. The medicinal products must be for use as a single treatment or as a single course of treatment, and it is necessary that the medicines be combined before administration or that they must be administered in a particular sequence. As per: TGA

Container
Definition: In relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion. As per: TGA

Designated active ingredients
Definition: For a complementary medicine, means an active ingredient, or a kind of active ingredient mentioned in schedule 14. Designated Active Ingredients. 1. Amino acid 2. Charcoal_3. A choline salt_4. An essential oil_5. Plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll 6. A homoeopathic preparation_7. A microorganism, whole or extracted, except a vaccine_8. A mineral including a mineral salt and a naturally occurring mineral_9. A mucopolysaccharides_10. Non-human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates_11. A lipid, including an essential fatty acid or phospholipid_12. A substance produced by or obtained from bees, including royal jelly, bee pollen and propolis_13. A sugar, polysaccharide or carbohydrate 14. A vitamin or provitamin. As per: TGA

Desktop review
Definition: The review of GMP documentary evidence for a manufacturer to ascertain an acceptable standard. As per: TGA

Dosage form
Definition: The pharmaceutical form in which a product is presented for therapeutic administration, e.g. tablet, cream. As per: TGA

European Pharmacopoeia
Definition: Means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the Council of Europe or any replacement body. As per: TGA

Excipient
Definition: Any component of a finished dosage form other than an active ingredient. As per: TGA

Excluded goods
Definition: Goods which might be considered to be therapeutic goods but which are specifically declared not to be by an Order of the Secretary. As per: TGA

Exempt goods
Definition: Therapeutic goods that are exempted from the requirements to be Registered or Listed, or are exempted from licensing requirements by the Therapeutic Goods Regulations. As per: TGA

Export name
Definition: The proprietary name used for the goods for supply in another country where that name is different from the proprietary name used for the goods for supply in Australia. As per: TGA

Export only medicine
Definition: Medicine that: a. Is manufactured in Australia for export only, or imported into Australia for export only; and_ b. is listable goods only because it is so manufactured or imported (and not for any other reason). As per: TGA

Extemporaneous compounding
Definition: Where the preparation is for use in the course of his or her business and: 1. The preparations are manufactured on premises that the person carrying on the business occupies and that he or she is able to close so as to exclude the public; and 2. The person carrying on the business: 1. supplies the preparation for administration to a particular person after consulting with that person; and 2. uses his or her judgement as to the treatment required. As per: TGA

FDA
Definition: USA Food and Drug Administration. As per: TGA

Finished goods
Definition: The finished or final dosage form of the therapeutic good when all stages of manufacture, other than release for sale, have been completed. As per: TGA

Formulation
Definition: A list of the ingredients used in the manufacture of a dosage form and a statement of the quantity of each ingredient in a defined weight, volume, unit or batch. As per: TGA

GMP clearance
Definition: The approval of GMP documentary evidence that shows a manufacturer is of an acceptable standard. As per: TGA

Good manufacturing practice (GMP)
Definition: The acronym GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality. A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process. As per: TGA

Grouped therapeutic goods
Definition: Medicines, devices or kits grouped under the one ARTG number. As per: TGA

HCN
Definition: Herbal component name. As per: TGA

Health enhancement
Definition: Specific beneficial effects of nutrients and other substances on the physiological and psychological state of the body above and beyond normal growth, development and functions of the body. (Specific indications) As per: TGA

Healthcare Professional
Definition: (a) Medical practitioners, psychologists, dentists, pharmacists, optometrists, chiropractors, physiotherapists, nurses, midwives, dental hygienists, dental prosthetists, dental therapists or osteopaths; or _ (b) Persons who are: _(i) engaged in the business of wholesaling therapeutic goods; or _(ii) purchasing officers in hospitals; or (c) Herbalists, homoeopathic practitioners, naturopaths, _nutritionists, practitioners of traditional Chinese medicine or podiatrists registered under a law of a State or Territory; or __ (d) A class of persons specified under subsection (1A). _ (1A) The Minister may, by legislative instrument, specify a class of persons for the purposes of paragraph (1)(d). As per: TGA

Indications
Definition: Means the specific therapeutic uses of the goods. As per: TGA

Licence
Definition: In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence. It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are exempt from this requirement. To obtain a licence to manufacture therapeutic goods, a manufacturer must demonstrate, during a factory audit, compliance with manufacturing principles which includes relevant Codes of GMP and Quality Systems. As per: TGA

Listable goods
Definition: Therapeutic goods that are required by the Act to be included in that part of the ARTG relating to Listed goods. As per: TGA

Listed goods
Definition: Therapeutic goods that are included in the part of the ARTG for goods known as Listed goods. As per: TGA

Listing number
Definition: See AUST L number. As per: TGA

Mainstream media
Definition: Any magazine or newspaper for consumers containing a range of news, public interest items, advertorials, advertisements or competitions. As per: TGA

Major variation
Definition: For therapeutic goods of a particular kind, means a change to: (a) The strength, as recorded in the entry in the Register; or _ (b) The dosage, the recommended dose regimen or the maximum daily dose; or _ (c) The dosage form; or _ (d) The route of administration; or _ (e) The intended patient group. _ As per: TGA

Manufacture
Definition: The production of medicines or any part of the process of producing medicines or bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process. As per: TGA

Manufacture licence
Definition: A licence granted under Part 3-3 of the Act, or a licence granted under a State or Territory law relating to therapeutic goods, relating to manufacturing therapeutic goods. As per: TGA

Manufacturer
Definition: Corporation or person carrying out one or more of the steps specified in the definition of manufacture. As per: TGA

Manufacturing sites
Definition: Premises: (a) That are for use in the manufacture of a particular kind of _therapeutic goods; and _ (b) At which the same persons have control of the management of the production of the goods and the procedures for quality control. As per: TGA

Member of EFTA
Definition: A country declared by the Minister under section 3A to be a member of the European Free Trade Association. As per: TGA

Minor variation
Definition: For therapeutic goods of a particular kind, means a change (other than a change that is a major variation) to: (a) The formulation, composition or design specification; or _ (b) The container for the goods; or (c) Any other attribute of the goods that results in the goods being separate and distinct. _ As per: TGA

Mother tincture
Definition: A product of the process of solution, extraction or trituration, from which homoeopathic preparations are made. As per: TGA

MRA
Definition: Mutual Recognition Agreement As per: TGA

Naturally - occurring chemical
Definition: A naturally-occurring chemical is defined in Section 5 of the Act as: "(a) An unprocessed chemical occurring in a natural environment,_or_(b) a chemical occurring in a natural environment, being a substance that is extracted by: (i) Manual, mechanical, or gravitational means, or (ii) Dissolution in water; or (iii) Flotation; or (iv) A process of heating for the sole purpose of removing uncombined water without a chemical change in the substance". As per: TGA

NCCTG
Definition: National Coordinating Committee on Therapeutic Goods As per: TGA

NDPSC
Definition: National Drugs and Poisons Schedule Committee As per: TGA

NHMRC
Definition: National Health and Medical Research Council As per: TGA

NICNAS
Definition: National Industrial Chemicals Notification and Assessment Scheme As per: TGA

Non-proprietary name
Definition: The name used to describe the goods (particularly medicines) in a specific standard, including the name of the dosage form (if no standard exists, a name may comprise the AAN of the active ingredient and the name of the dosage form). As per: TGA

Non-specific Indication
Definition: Refer to general health and wellbeing, such as: - health maintenance - relief of symptoms not related to a named condition; and - general vitamin, mineral or nutritional supplementation. As per: TGA

OCM
Definition: TGA Office of Complementary Medicines As per: TGA

Pack size
Definition: The size of the goods in terms of the quantity contained in the container (e.g. volume in a multi-use container) and/or the number of items in the primary/unit pack (e.g. number of tablets in a bottle). As per: TGA

PIC/S
Definition: Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. As per: TGA