Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsIn these Regulations, unless the contrary intention appears:
"active implantable therapeutic device" :
(a) means an active therapeutic device designed for implantation, totally or partially, into the human body:
(i) surgically; or
(ii) by other medical intervention, into a natural orifice; and
(b) includes an accessory designed for use with the device.
"active ingredient" has the same meaning as in section 52F of the Act.
"active therapeutic device" means a device that relies for its functioning on a source of electrical energy or any other source of power that is not generated directly by the human body or by gravity.
"analysis" includes examination and testing.
"antiseptic" means 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.
"ASMI" means Australian Self-Medication Industry Incorporated (ABN 55 082 798 952).
"authorised officer" , in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.
Note Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.
"Australian Approved Names List" means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.
Note 1 The Australian Approved Names List includes:
(a) Australian Approved Names -- Chemicals List; and
(b) Australian Approved Names -- Biological Lists; and
(c) the Herbal Substances AAN List.
Note 2 The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Medicines.
"CHCA" means the Complementary Healthcare Council of Australia.
"Complaints Resolution Panel" means the panel established under regulation 42R.
"complementary medicines" has the same meaning as in section 52F of the Act.
"Complementary Medicines Evaluation Committee" means the Committee established under subsection 52G (1) of the Act.
"critical medical device" means a device that, when used as recommended by its manufacturer, is in a sterile condition on introduction into the human body.
"designated orphan drug" means an orphan drug designated under subregulation 16J (2).
"designated therapeutic goods" means therapeutic goods other than:
(a) therapeutic devices; and
(b) goods included in Schedule 3 to the Poisons Standard that are not included in Appendix H of that standard; and
(c) goods included in Schedule 4 or 8 to the Poisons Standard.
"diagnostic goods for in vitro use means any therapeutic device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination (with other diagnostic goods for in vitro use), intended by the manufacturer to be used in vitro" for the examination of specimens (including blood and tissue donations) derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state or a congenital abnormality or to determine safety and compatibility with a potential recipient.
"disinfectant" means a substance:
(a) that is recommended by its manufacturer for application to an inanimate object to kill micro organisms; and
(b) that is not represented by the manufacturer to be suitable for internal use.
"expiry date" , for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.
"fungicide" means a chemical agent that kills a fungus or spores of a fungus.
generic medicine means a medicine that, in comparison to a registered medicine:
(a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine; and
(b) has the same pharmaceutical form; and
(c) is bioequivalent; and
(d) has the same safety and efficacy properties.
"gene therapy" means the in vivo transfer of DNA or RNA into the cells of human recipients.
"goods for home use , in relation to diagnostic goods for in vitro" use, means goods supplied to a person for that person:
(a) to use in diagnosing or monitoring a condition in that person or the immediate family of that person; or
(b) to use in the collection of a sample of a body specimen of that person and, if the sample is tested by another person, if and only if the results of the test are to be returned by that other person to the person from whom the sample was taken.
"herbal substance" means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):
(a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and
(b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.
"high level disinfectant" means a disinfectant that:
(a) kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer; and
(b) is the minimum treatment recommended by the manufacturer of a semi critical medical device for the reprocessing of the device.
"homoeopathic preparation" means a preparation:
(a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and
(b) prepared according to the practices of homoeopathic pharmacy using the methods of:
(i) serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
(ii) serial trituration in lactose.
"hospital grade disinfectant" means a disinfectant that is represented to be suitable for therapeutic use:
(a) in premises used for:
(i) the investigation or treatment of a disease, ailment or injury; or
(ii) procedures that are carried out involving the penetration of the human skin; or
(b) in connection with:
(i) the business of beauty therapy or hairdressing; or
(ii) the practice of podiatry;
but does not include:
(c) an antibacterial clothes preparation; or
(d) a sanitary fluid; or
(e) a sanitary powder; or
(f) a sanitiser.
"household grade disinfectant" means a disinfectant that is not:
(a) an antibacterial clothes preparation; or
(b) a hospital grade disinfectant; or
(c) a sanitary fluid; or
(d) a sanitary powder; or
(e) a sanitiser.
"immediate family , in relation to a person, means the parents, grandparents, spouse, de facto" spouse, child or ward of that person.
"implantable" , in relation to a therapeutic device, means designed to be implanted into the tissues or body cavities of a person or animal, other than in the teeth, for a period of 30 days or more.
"instrument grade disinfectant" means:
(a) a high level disinfectant; or
(b) a sterilant;
that is used to reprocess reusable semi critical or critical medical devices.
"mother tincture" means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.
"NFAA" means the Nutritional Foods Association of Australia.
"non critical medical device" means a device that, when used as recommended by its manufacturer:
(a) does not ordinarily contact the human body; or
(b) if contact with the human body is made -- contacts only healthy intact skin.
"official analyst" means a person approved by the Secretary under regulation 25.
"open shelf life" , for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.
Note For container , see Act, subs 3 (1).
"orphan drug " has the meaning given by regulation 16H.
"OTC medicine" means therapeutic goods mentioned in Part 3 of Schedule 10.
"pharmaceutical benefit" means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans' Entitlements Act 1986 .
"Poisons Standard has the same meaning as current Poisons Standard" .
"Practice Guidelines" has the meaning given by paragraph 12AB (2) (a).
"principal investigator" , in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.
"quarter" means a period of 3 months commencing on 1 January, 1 April, 1 July or 1 October in a year.
"rare disease" means a disease, or condition, likely to affect not more than 2,000 individuals in Australia at any time.
"Required Advisory Statements for Medicine Labels" means the document of that name published by the Therapeutic Goods Administration on 1 July 2004, as in force from time to time.
"sample" includes part of a sample.
"semi critical medical device" means a device that, when used as recommended by its manufacturer:
(a) makes contact with healthy intact mucous membranes of the human body; and
(b) does not ordinarily enter normally sterile areas of the body.
"serious" , 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.
"specialist" has the same meaning as in the Health Insurance Act 1973 .
"sporicide" means a chemical agent that:
(a) kills bacterial spores; and
(b) has the potential to act as a sterilising agent after prolonged contact with an inanimate object.
"Standard AS/NZS" means a joint Australian and New Zealand Standard published by the Standards Australia International Limited and the body known as Standards New Zealand.
"sterilant" means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10 -6 .
"submission" has the meaning given by subclause 1 (2) in Part 1 of Schedule 9.
"the Act" means the Therapeutic Goods Act 1989 .
"Therapeutic Goods Advertising Code" means the Code known as the Therapeutic Goods Advertising Code as in force from time to time.
trade name , for therapeutic goods of a particular kind, means the commercial name:
(a) given to goods of that kind by the manufacturer; and
(b) under which the goods are supplied.
"traditional use" has the same meaning as in section 52F of the Act.
"tuberculocide means a chemical agent that kills Mycobacterium tuberculosis" and related acid-fast bacteria.
"unused emergency goods" means goods to which section 30G of the Act applies.
"virucide" means a chemical agent that renders a virus non-infective.
Note Definitions of medicine and poison are in the Act (see subsection 3 (1)).