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Acronyms & glossary

25 July 2011

The following terms, definitions & acronyms are used in Australian therapeutic goods regulation. They are provided as general information only and this is not intended to be an exhaustive list.

Refer to Australian therapeutic goods legislation for legal definitions and for other terms not included on this page.

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

A

AAN - Australian approved names (see TGA approved terminology for medicines)

ABN - Australian Business Number or Australian Biological Name

ACMD - Advisory Committee on Medical Devices

ACNM - Advisory Committee on Non-prescription Medicines

ACPM - Advisory Committee on Prescription Medicines

ACSOM - Advisory Committee on the Safety of Medicines

[the] Act - the Therapeutic Goods Act 1989

active implantable medical device (AIMD) - an active medical device (other than an implantable medical device) that is intended by the manufacturer:

1. either:
   1. to be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
   2. to be, by medical intervention, introduced into a natural orifice in the body of a human being; and
2. to remain in place after the procedure.

active ingredient - the therapeutically active component in a medicine's final formulation that is responsible for its physiological action

active medical device

1. a medical device that is intended by the manufacturer:
   1. to depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
   2. to act by converting this energy; but
2. does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted

active pharmaceutical ingredient (API) - therapeutically active component in the final formulation of therapeutic goods

active raw material - 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 excipients

ADEC - Australian Drug Evaluation Committee (replaced in 2010 by the Advisory Committee on Prescription Medicines (ACPM))

adverse drug reaction (ADR) - see Guidelines on the reporting of adverse drug reactions by drug sponsors: Definitions

ADRAC - Adverse Drug Reactions Advisory Committee (replaced in 2010 by the Advisory Committee on the Safety of Medicines (ACSOM))

advertisement - any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods (also see Advertising therapeutic products)

adverse event (AE) - see Guidelines on the reporting of adverse drug reactions by drug sponsors: Definitions

AHMAC - Australian Health Ministers' Advisory Council

AHN - Australian Herbal Name (see TGA approved terminology for medicines)

AHS - Australian herbal substance

AIVC - Australian Influenza Vaccine Committee

antiseptic - a substance:

1. that is recommended by its manufacturer for:
   1. dermal application; or
   2. application to the mucous membranes of a person or an animal:
      1. to kill micro organisms; or
      2. to prevent the growth of micro organisms to a level that causes or may cause clinical infection; and
2. that is not represented to be suitable for internal use.

ANZTPA - Australia New Zealand Therapeutic Products Authority

APVMA - Australian Pesticides and Veterinary Medicines Authority

ARGCM - Australian Regulatory Guidelines for Complementary Medicines

ARGMD - Australian Regulatory Guidelines for Medical Devices

ARGOM - Australian Regulatory Guidelines for OTC Medicines

ARGPM - Australian Regulatory Guidelines for Prescription Medicines

ARTG - Australian Register of Therapeutic Goods

AUST L number - the unique ARTG number for a listed therapeutic product (also see: What's on a medicine label?)

AUST R number - the unique ARTG number for a registered therapeutic product (also see: What's on a medicine label?)

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B

batch - a quantity of a product that is:

1. uniform in composition, method of manufacture and probability of chemical or microbial contamination; and
2. 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

BP - British Pharmacopoeia

broadcast media - 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

BSE - bovine spongiform encephalopathy (see Transmissible spongiform encephalopathies (TSEs))

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C

category A patient - a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment (see Special Access Scheme)

category B patient - all other patients that do not fit the Category A definition (see Special Access Scheme)

CHMP - European Medicines Agency Committee for Medicinal Products for Human Use

Client ID - identification code assigned by the TGA to a client

clinical trial - a planned study in humans designed to investigate or report upon the effectiveness and/or safety of a therapeutic good

CLP - Certificate of Listed Product

CMEC - Complementary Medicines Evaluation Committee (replaced in 2010 by the Advisory Committee on Complementary Medicines (ACCM))

complementary medicine - therapeutic goods consisting wholly or principally of one or more designated active ingredients, each or which has a clearly established identity and

1. a traditional use OR
2. any other use prescribed in the regulations

Schedule 14 of the Therapeutic Goods Regulations 1990 defines the following as 'designated active ingredients':

1. an 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 mucopolysaccharide
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

composite pack [medical devices] - see Australian Regulatory Guidelines for Medical Devices

composite pack [medicine] - 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

Examples:

• a strip or blister pack containing tablets or capsules with differing formulations to be taken in a specified order
• a primary pack containing an active ingredient in one vial and a diluent in another vial
• a primary pack containing separate containers of different formulations for use as part of a single regimen of treatment

conformity assessment - see Australian Regulatory Guidelines for Medical Devices

Consumer Medicine Information (CMI) - document required to be provided to patients with prescription medicines that gives a plain-English explanation of the product

container - 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

CPP - Certificate of Pharmaceutical Product

critical medical device - a device that, when used as recommended by its manufacturer, is in a sterile condition on introduction into the human body

CTD - Common technical document

CTN - Clinical trial notification (see Clinical trials)

CTX - Clinical trial exemption scheme (see Clinical trials)

custom-made medical device - a medical device that:

1. is specifically made in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and
2. is intended to be used only in relation to a particular individual

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D

DEAL - Device Electronic Application Lodgement (see TGA eBusiness services)

desktop review - The review of GMP documentary evidence for a manufacturer to ascertain an acceptable standard

direct diagnosis - in relation to a patient, means continuous surveillance by direct measurement

directions for use - includes information on:

1. appropriate uses of the therapeutic goods
2. the method of administration or use of the goods
3. the frequency and duration of treatment for each indication of the goods
4. the use of the goods by persons of particular ages or by persons having particular medical conditions

disinfectant - a substance:

1. that is recommended by its manufacturer for application to an inanimate object to kill micro organisms; and
2. that is not represented by the manufacturer to be suitable for internal use

dosage form - the pharmaceutical form in which a product is presented for therapeutic administration, e.g. tablet, cream (see TGA approved terminology for medicines)

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E

EC-MRA - Australia - European Community mutual recognition agreement

EEL - Export Only [medicines] Lodgement System (see TGA eBusiness services)

EFTA-MRA - Australia - European Free Trade Association mutual recognition agreement

ELF - Electronic Listing Facility (see TGA eBusiness services)

EMEA - European Medicines Agency

EP - European Pharmacopoeia

essential principles - the essential principles set out the requirements relating to the safety and performance characteristics of medical devices (see the Australian Regulatory Guidelines for Medical Devices)

EU - European Union

excipient - any component of a finished dosage form other than an active ingredient

excluded goods - goods which might be considered to be therapeutic goods but which are specifically declared not to be by an Order of the Secretary (and therefore not subject to any requirements of the Act)

exempt goods - therapeutic goods that are exempted from the requirements to be Registered or Listed, or are exempted from licensing requirements by the Therapeutic Goods Regulations

export name - 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

export only medicine - medicine that:

1. is manufactured in Australia for export only, or imported into Australia for export only; and
2. is listable goods only because it is so manufactured or imported (and not for any other reason)

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F

FDA - USA Food and Drug Administration

finished goods - the finished or final dosage form of the therapeutic good when all stages of manufacture, other than release for sale, have been completed

formulation - 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

FSANZ - Food Standards Australia New Zealand

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G

gazetted therapeutic goods group - a group of medicines which have common characteristics, that are identified in an order published in the Commonwealth Government Notices Gazette (see Groups orders)

generic medicine - a medicine that, in comparison to a registered medicine:

1. has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine; and
2. has the same pharmaceutical form; and
3. is bioequivalent; and
4. has the same safety and efficacy properties

GHTF - Global Harmonization Task Force

GMDN (Global Medical Device Nomenclature) - a collection of internationally recognised terms used to accurately describe and catalogue medical devices, in particular, those products used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans

GMP clearance - The approval of GMP documentary evidence that shows a manufacturer is of an acceptable standard

good manufacturing practice (GMP) - 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. (Also see: Good manufacturing practice for therapeutic goods)

grouped therapeutic goods - medicines, devices or kits grouped under the one ARTG number (not to be confused with gazetted therapeutic goods group which only refers to medicines)

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H

HCN - Herbal component name

HCT - Human cellular and tissue therapies

herbal substance - all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):

1. 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
2. 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

homoeopathic preparations - a preparation:

1. 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
2. prepared according to the practices of homoeopathic pharmacy using the methods of:
   1. serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
   2. serial trituration in lactose

HPCs - Haematopoietic progenitor cells

HREC - Human research ethics committee

HRT - Hormone replacement therapy

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I

ICH - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

implantable medical device - a medical device (other than an active implantable medical device) that is intended by the manufacturer:

1. to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure; or
2. to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a human being, and to remain in place after the procedure; or
3. to be, by surgical intervention, partially introduced into the body of a human being, and to remain in place for at least 30 days after the procedure

included in the Register - in relation to a medical device to which Chapter 4 of the Therapeutic Goods Act 1989 applies, means included in the ARTG

Note: For medical devices to which Chapter 4 applies, see section 41BJ of the Act.

indications - means the specific therapeutic uses of the goods

informed consent - in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment

intended purpose - of a kind of medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in:

1. the information provided with the device; or
2. the instructions for use of the device; or
3. any advertising material applying to the device

invasive medical device - a medical device that is intended by the manufacturer to be used, in whole or in part, to penetrate the body of a human being through a body orifice or through the surface of the body

IRIS - Incident Report Investigation Scheme (for medical devices)

ISO - International standard

IVD or IVDD - in vitro diagnostic device

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J

K

kit - listed as either medicine or device kits. A package and therapeutic goods in the package together constitute a kit for the purposes of the Therapeutic Goods Act 1989 if:

1. the package and the therapeutic goods are for use as a unit; and
2. each item of the therapeutic goods consists of goods that are registered or listed or are exempt goods in relation to Part 3-2; and
3. the package and therapeutic goods do not constitute a composite pack or a system or procedure pack.

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L

label - means a display of printed information:

1. on or attached to the goods; or
2. on or attached to a container or primary pack in which the goods are supplied; or
3. supplied with such a container or pack

licence - 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.

listable goods - therapeutic goods that are required by the Act to be included in that part of the ARTG relating to Listed goods

listed goods - therapeutic goods that are included in the part of the ARTG for goods known as Listed goods

listed medicine - see Medicines and TGA classifications

listing number - see AUST L number

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M

mainstream media - any magazine or newspaper for consumers containing a range of news, public interest items, advertorials, advertisements or competitions

manufacture - 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

manufacturer - corporation or person carrying out one or more of the steps specified in the definition of manufacture

manufacturer of a medical device

1. The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name, whether or not it is the person, or another person acting on the person's behalf, who carries out those operations.
2. If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person's name, does one or more of the following using ready-made products:
   1. assembles the device;
   2. packages the device;
   3. processes the device;
   4. fully refurbishes the device;
   5. labels the device;
   6. assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:
      1. the labelling on the device;
      2. the instructions for using the device;
      3. any advertising material relating to the device.
3. However, a person is not the manufacturer of a medical device if:
   1. the person assembles or adapts the device for an individual patient; and
   2. the device has already been supplied by another person; and
   3. the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:
      1. the labelling on the device;
      2. the instructions for using the device;
      3. any advertising material relating to the device.

manufacturing licence - 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

manufacturing certificates

• Certificate of GMP Compliance
• GMP Certificate of Manufacturing Facility
• Certificate of GMP Compliance of a Manufacturer

MDEC - Medical Devices Evaluation Committee (replaced in 2010 by the Advisory Committee on Medical Devices (ACMD))

medical device - see What is a medical device

medicine

1. therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal
2. any other therapeutic goods declared by the Secretary, for the purposes of the definition of therapeutic device, not to be therapeutic devices

MEC - Medicines Evaluation Committee (replaced in 2010 by the Advisory Committee on Non-prescription Medicines (ACNM))

MMF - Manufacturer's Master File

MoI - Memorandum of Intention

mother tincture - a product of the process of solution, extraction or trituration, from which homoeopathic preparations are made

MoU - Memorandum of Understanding

MRA - Mutual Recognition Agreement

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N

NCCTG - National Coordinating Committee on Therapeutic Goods

NDPSC - National Drugs and Poisons Schedule Committee (replaced in 2010 by the Advisory committees on medicines & chemicals scheduling (ACMS & ACCS))

NHMRC - National Health and Medical Research Council

NICNAS - National Industrial Chemicals Notification and Assessment Scheme

non-critical device - a device that only comes in contact with intact skin or does not come in contact with the human body.

non-proprietary name - 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)

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O

OCM - [TGA] Office of Complementary Medicines

ODBT - [TGA] Office of Devices, Blood and Tissues (replaced in 2010 by the Office of Devices Authorisation (ODA))

OLSS - [TGA] Office of Laboratories and Scientific Services (previously known as TGA Laboratories (TGAL))

OMQ - [TGA] Office of Manufacturing Quality (previously known as Manufacturers Assessment Branch (MAB))

OMSM - [TGA] Office of Medicines Safety Monitoring (previously known as Adverse Drug Reactions Unit (ADRU) and replaced in 2010 by the Office of Product Review (OPR))

Open-but-unused - refers to a single use device where the packaging has been damaged or opened but the device not used and/or did not come in contact with blood, tissue or body fluids

ONPM - [TGA] Office of Non Prescription Medicines (replaced in 2010 by the Office of Medicines Authorisation (OMA))

OPM - [TGA] Office of Prescription Medicines (previously known as Drug Safety and Evaluation Branch (DSEB) and replaced in 2010 by the Office of Medicines Authorisation (OMA))

OTC - Over-the-Counter (medicines)

OTGs - Other therapeutic goods

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P-Q

pack size - 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)

PH Eur - European Pharmacopoeia

principal manufacturer - 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

Product Information (PI) - information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods

PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

PMF - Can mean Plasma Master File or Plant Master File depending on the context

Poisons Standard - decisions regarding the classification of drugs and poisons into Schedules for inclusion in the relevant legislation of the States and Territories (also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP))

potentially hazardous - in relation to a medical device, means that the basic risk of the device, before deliberate measures have been taken to minimise risk by inherent design or protection mechanisms, is considered intolerable

primary pack - the complete pack in which the goods, or the goods and their container, are to be supplied to consumers

procedure pack - see Australian Regulatory Guidelines for Medical Devices

prohibited representation - a representation referred to in subsection 42DJ(1) of the Act

proprietary ingredient - formulated ingredients, usually commercially obtained, for which the formulation may not be available to the sponsor of the final product

proprietary name - the registered trademark of the therapeutic goods or the unique name assigned to the goods by the sponsor and appearing on the label

PSC - Pharmaceutical Subcommittee (of ACPM)

Q

QA - quality assurance

QMS - Quality Management System

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R

recall - an action taken to resolve a problem with therapeutic goods for which there are established deficiencies in quality, efficacy or safety (see About recalls)

refurbishment - is taken to have occurred if the medical device, or a part of the device, is substantially rebuilt from one or more used medical devices of that kind so as to create a medical device that is able to be used for the purpose originally intended by the manufacturer of the original device

Refurbishment of a medical device may involve the following actions:

• stripping the device into component parts or sub assemblies
• checking parts of the device for suitability for reuse
• replacing component parts or sub assemblies of the device that are not suitable for reuse
• assembling reclaimed or replacement component parts or sub assemblies of the device or another used device
• testing a reassembled device against the specifications of the original device or, if the manufacturer has revised those specifications, the revised specifications
• identifying an assembled device as a refurbished device

[the] Register - the Australian Register of Therapeutic Goods

registered goods - therapeutic goods included in the part of the ARTG for goods known as Registered goods

registered medicine - see Medicines and TGA classifications

registrable goods - goods that are required by the Act to be included in that part of the ARTG for Registered goods

registration number - see AUST R number

re-manufacture - refers to one or more of the following activities carried out on single use devices to supply for reuse:

• Assembly the device; or
• Packaging the device; or
• Processing the device; or
• Fully refurbishing the device; or
• Labelling the device; or
• Assigning the device a new intended purpose by means of information supplied by on or in the labelling; the instructions for use or advertising material

In the process, the person responsible for undertaking these activities on a single use device has:

• Changed the intended purpose of the device;
• Certified the device is suitable for reuse; and
• Assumed the legal liability for the quality, safety and performance of the device

restricted representation - 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 (also see Restricted representations)

reuse - the repeated use or multiple use of any medical device which has undergone some form of reprocessing (cleaning, disinfection or sterilisation) between each episode of use

reusable device - a device designed or intended by the manufacturer as suitable for reprocessing and reuse. It is not a device that is designed or intended by the manufacturer for single use only.

route of administration - route by which a therapeutic good is applied on or introduced into the body

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S

SAS - Special Access Scheme

semi-critical device - a device is one that comes into contact with intact mucous membranes or broken skin. The device should be sterilised where possible, or high-level disinfected.

serious AE/ADR - see Guidelines on the reporting of adverse drug reactions by drug sponsors: Definitions

SIME - Strategic Information Management Environment - now called TGA eBusiness services

single patient use - more than one episode of use of a medical device on one patient only, the device may undergo some form of reprocessing between each use in accordance with the manufacturers instructions for reuse on the same patient

single use - means the medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used on another patient.

Some single-use devices are marketed as non-sterile which require processing to make them sterile and ready for use. The manufacturer of the device will include appropriate processing instructions to make it ready for use

SMF - Site Master File

specified media - in relation to an advertisement or generic information, means:

1. mainstream media within the meaning of Section 42B of the Act OR
2. cinematograph films OR
3. displays about goods, including posters
   1. in shopping malls (except inside an individual shop)
   2. in or on public transport
   3. on billboards

sponsor - in relation to therapeutic goods, means:

1. a person who exports, or arranges the exportation of, the goods from Australia; or
2. a person who imports, or arranges the importation of, the goods into Australia; or
3. a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);

but does not include a person who:

4. exports, imports or manufactures the goods; or
5. arranges the exportation, importation or manufacture of the goods;

on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.

supply - 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)

SUSDP - Standard for the Uniform Scheduling of Drugs and Poisons (replaced in 2010 by the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP))

SUSMP - Standard for the Uniform Scheduling of Medicines and Poisons (also known as the Poisons Standard)

Symbol : - The international recognised symbol described in ISO 15223:2007: - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied and means DO NOT REUSE. The synonyms for this symbol are "single use" or "use only once".

systems [regulated devices] - See Australian Regulatory Guidelines for Medical Devices

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T

tamper - therapeutic goods are tampered with if:

1. they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and
2. the interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.

TEP - Tamper-evident packaging

TGA - Therapeutic Goods Administration

TGACC - Therapeutic Goods Advertising Code Council

TGC - Therapeutic Goods Committee

TGO - Therapeutic goods order

therapeutic good - see What are 'therapeutic goods'?

therapeutic use - see What are 'therapeutic goods'?

Therapeutic Goods Advertising Code (TGAC) - see Therapeutic Goods Advertising Code

TICC - TGA-Industry Consultative Committee

topical - applied to a certain area of the skin for a localised effect

transdermal - applied to the skin for a systemic effect by the diffusion or continuous absorption of the active ingredient through the skin

traditional use - 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

TSE - transmissible spongiform encephalopathies

TWG - Technical Working Groups [manufacturing]

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U

URPTG - Uniform Recall Procedure for Therapeutic Goods

used - For medical devices that are supplied sterile:

• the device has been placed into a wound or body cavity and comes into contact with blood or body fluids; or
• has been opened but cannot be reprocessed because the manufacturer did not provide instructions on how to reprocess the device if the package is opened or damaged.

For medical devices that are supplied non-sterile:

• the device has been applied for its intended purpose.

USP - United States Pharmacopoeia

V-W-X-Y-Z

vital physiological process - 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:

1. respiration
2. heart rate
3. cerebral function
4. blood gases
5. blood pressure
6. body temperature

WHO - World Health Organization

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