Definition: The therapeutically active component in a medicine's final formulation that is responsible for its physiological action. As per: TGA Show 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 Poison Definition: An ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury and includes any ingredient, compound, material or preparation referred to in a schedule to the current Poisons Standard. As per: TGA Presentation Definition: In relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods. As per: TGA Primary pack Definition: The complete pack in which the goods, or the goods and their container, are to be supplied to consumers. As per: TGA Principal Manufacturer Definition: The manufacturer who manufactures the goods or who performs one or more steps in the manufacture of the goods and also contracts with, or controls the use of other sub-manufacturers for the performance of the remaining steps in manufacture of the goods. As per: TGA Product Information Definition: Information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods. As per: TGA Prohibited representation Definition: A representation referred to in subsection 42DJ(1) of the Act As per: TGA Proprietary ingredient Definition: Formulated ingredients, usually commercially obtained, for which the formulation may not be available to the sponsor of the final product. As per: TGA Proprietary name Definition: The registered trademark of the therapeutic goods or the unique name assigned to the goods by the sponsor and appearing on the label. As per: TGA QA Definition: Quality assurance. As per: TGA QMS Definition: Quality Management System. As per: TGA Quality Definition: In relation to therapeutic goods, includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction and performance characteristics of the goods. As per: TGA Recall Definition: An action taken to resolve a problem with therapeutic goods for which there are established deficiencies in quality, efficacy or safety. As per: TGA Restricted medicine Definition: (a) A medicine specified in an instrument under subsection (2A); _or _ (b) A medicine included in a class of medicine specified in an instrument under subsection (2B). _ As per: TGA Restricted representation Definition: Any reference expressly or by implication, to a disease, condition, ailment or defect specified in Table 1, Appendix 6 of the Therapeutic Goods Advertising Code. As per: TGA Route of administration Definition: Route by which a therapeutic good is applied on or introduced into the body. As per: TGA Scheduling Definition: In relation to a substance, means determining the schedule or schedules to the current Poisons Standard in which the name or a description of the substance is to be included. As per: TGA Scientific evidence Definition: refers to quantifiable data and usually includes reports of clinical trials in humans, human epidemiological studies, animal studies and other cellular or pharmacological studies. Due to the quantifiable nature of scientific evidence, scientific indications can imply clinical efficacy where the indication is supported by such data. As per: TGA Serious Definition: In relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is: (a) Generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or (b) Generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional. As per: TGA Specific indication Definition: Refer to health benefits beyond general health and wellbeing, such as: - health enhancement - reduction of risk or frequency of a named condition or symptoms - management or relief of symptoms linked to a named condition; and - nutritional supplementation claims linked to a specific therapeutic benefit. As per: TGA Specified media Definition: In relation to an advertisement or generic information, means: a. Mainstream media within the meaning of Section 42B of the Act OR b. Cinematograph films OR c. Displays about goods, including posters_i. in shopping malls (except inside an individual shop) ii. In or on public transport iii. on billboards As per: TGA Supply Definition: Includes supply by way of sale, exchange, gift, lease, loan, hire or hire purchase (it also includes whether free of charge or otherwise, samples or advertisements, supply for testing the safety or efficacy, and for treatment of person or animal). As per: TGA SUSMP Definition: Standard for the Uniform Scheduling of Medicines and Poisons As per: TGA Tamper Definition: Therapeutic goods are tampered with if: a. They are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and b. The interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person. As per: TGA TEP Definition: Tamper evident packaging As per: TGA TGA Definition: Therapeutic Goods Administration As per: TGA TGACC Definition: Therapeutic Goods Advertising Code Council As per: TGA TGC Definition: Therapeutic Goods Committee As per: TGA TGO Definition: Therapeutic Goods Order As per: TGA Therapeutic good Definition: Goods: (a) 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: (i) For therapeutic use; or _ (ii) For use as an ingredient or component in the manufacture of therapeutic goods; or _ (iii) For use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or _ (b) Included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii); _ And includes medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include: (c) Goods declared not to be therapeutic goods under an order in force under section 7; or (d) Goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or _ (e) Goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a standard (within the meaning of subsection 4(1) of the Food Standards Australia New Zealand Act 1991); or _ (f) Goods (other than goods declared to be therapeutic goods under an order in force under section 7) which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented. _ As per: TGA Therapeutic Goods Act (1989) Definition: (the act) is administered by the TGA and provides a uniform national framework for import, export, manufacture and supply of therapeutic goods. As per: TGA Therapeutic Goods Advertising Code Council Definition: The broadly representative body of peak stakeholder groups, established in the Regulations to the Therapeutic Goods Act 1989 to: (a) Consider the requirements for the advertising of therapeutic goods and changes to this Code, to accept submissions for this purpose and to advise the Minister accordingly; and _ (b) to make recommendations to the Minister for achieving greater uniformity in approval processes and standards for the advertising of therapeutic goods, _ Amongst other matters (as outlined in the Regulations). As per: TGA Therapeutic use Definition: Use in or in connection with: (a) Preventing, diagnosing, curing or alleviating a disease, _ailment, defect or injury in persons; or _ (b) Influencing, inhibiting or modifying a physiological process in persons; or _ (c) Testing the susceptibility of persons to a disease or ailment; or _ (d) Influencing, controlling or preventing conception in persons; or _ (e) Testing for pregnancy in persons; or _ (f) The replacement or modification of parts of the anatomy in _persons. _ As per: TGA Topical Definition: Applied to a certain area of the skin for a localised effect. As per: TGA Traditional indications Definition: Needs to show that the medicine or the relevant ingredients in the medicine have a significant history of use in the specified tradition for the specified therapeutic purpose. You are required to hold documentary evidence that your medicine or its active ingredient has been used for at least three generations (at least 75 years) in the tradition it belongs to. This will establish that it belongs to that tradition and that there is an accumulated repository of observations in humans that underpins the use of the medicine. As per: TGA Traditional use Definition: Use of a designated active ingredient that is well-documented, or otherwise established, according to the accumulated experience of many traditional healthcare practitioners over an extended period; and accords with well-established procedures of preparation, application and dosage. As per: TGA TSE Definition: Transmissible spongiform encephalopathies. As per: TGA Typical Definition: That which reflects the characteristic of a group ie. a result obtained from the use of a product which would be likely to be attained by most people using the product within the audience to which the advertisement is directed. As per: TGA URPTG Definition: Uniform Recall Procedure for Therapeutic Goods. As per: TGA USP Definition: United States Pharmacopoeia. United States Pharmacopeia-National Formulary 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 United States Pharmacopeial Convention or any replacement body. As per: TGA Vital physiological process Definition: Of a patient, means a process that is necessary to sustain life and the indicators of which may include any 1 or more of the following: a. Respiration_b. heart rate_c. cerebral function d. blood gases_e. blood pressure f. body temperature. As per: TGA Where would you find the schedule of a drug or poison?The Schedules are published in the Poisons Standard and are given legal effect through state and territory legislation. The Poisons Standard is also referred to as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
What is scheduling in relation to medication administration?Scheduling is a national classification system that controls how medicines and chemicals are made available to the public. Medicines and chemicals are classified into Schedules according to the level of regulatory control over the availability of the medicine or chemical, required to protect public health and safety.
How are medications regulated by the TGA for use in Australia?Medicines assessed as having a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy. Ingredients in medicines with a lower risk (medicines purchased over the counter, such as complementary medicines) are assessed for quality and safety.
What are the 4 categories of medicine?The 4 Categories of Medication. General Sales List (GSL) GSLs are a type of medicine that have few legal restrictions. ... . Pharmacy Medicines. Pharmacy Medicines are only available to purchase behind the counter at a pharmacy. ... . Prescription Only Medicines. ... . Controlled Drugs.. |
