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Acronyms & glossary

25 March 2014

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

AAT

Administrative Appeals Tribunal

ABN

Australian Business Number or Australian Biological Name

Acceptable country

Refers to 'a country that the Minister has notified in the Gazette as an acceptable country for the purposes of this Regulation', as described by Regulation 16C of the Therapeutic Goods Regulations 1990.

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))

Adjuvant

A drug or other substance that enhances the activity of another.

(in immunology) A component that potentiates the immune response to an antigen and/or modulates it towards the desired immune response.

(in chemotherapy) The use of anticancer drugs after, or in combination with, another form of cancer treatment (e.g. after surgical removal of a cancer. The method is used where there is a significant risk that undetected cancer cells may still be present.

ADRAC

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

Adventitious agent

In the context of guidance about adventitious agent safety of medicines and therapeutic goods that contain or are produced from human blood or plasma means:

An infectious agent that is introduced into a therapeutic good during collection of raw materials or the manufacturing process. Adventitious agents include mycoplasma (a type of bacteria), viruses and agents that cause transmissible spongiform encephalopathies (prions).

Adventitious agent safety

In the context of guidance about adventitious agent safety of medicines means:

The implementation of control processes to prevent adventitious agents entering therapeutic goods, or to reduce or inactivate adventitious agents that may be in the therapeutic goods during the manufacturing process. It applies to all medicines that contain, or are manufactured using, material of animal or human origin.

Adverse drug reaction (ADR)

See Guidelines on the reporting of adverse drug reactions by drug sponsors: Definitions

Adverse event (AE)

See Guidelines on the reporting of adverse drug reactions by drug sponsors: Definitions

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)

Agent

A person duly authorised in writing to act on behalf of the sponsor of the goods.

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

ALARP

As low as reasonably practicable

Analysis

Refers to'includes examination and testing', as described by Regulation 2, Part 1(2) of the Therapeutic Goods Regulations 1990.

Antibiotic

In relation to guidance about drug master files and certificates of suitability means:

A selective antimicrobial agent, other than disinfectants, antiseptics and substances solely used as antineoplastics, that, on application to living tissue or by systemic administration, kills or prevents growth of susceptible micro-organisms.

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

Appellant

In the terms of the Therapeutic Goods Act 1989 – a person seeking a review of a decision under the provisions of Section 60C of the Therapeutic Goods Act 1989.

Applicant

A person who has made an application, or is intending to make an application, pursuant to the Therapeutic Goods Act 1989, and who can provide evidence of this on request.

Application

Made to the TGA under the following sections of the Therapeutic Goods Act 1989 (note that where the section/regulation number is highlighted, the word'application' is used in the legislation):

  • Section 9C (request for copy of ARTG entry); or
  • Section 9D (request to vary information about and ARTG entry); or
  • Section 14 (exemption from compliance with a Standard); or
  • Section 19 (exemptions for special and experimental uses); or
  • Section 23 (registration or listing) [note that each application results in a single registration or listing or the inclusion of a separate and distinct product within a grouped registration or listing]; or
  • Section 37 (application for licence); or
  • Section 58 (export certifications); or
  • Section 61(6) (release of information); or
  • Regulation 14 (transfer of goods registered/listed); or
  • Regulation 14A (reassignment of registration / listing numbers).
(See also submission).

 

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

ARPANSA

Australian Radiation Protection and Nuclear Safety Agency

ARTG entry

Refers to a separate and distinct product included in the Australian Register of Therapeutic Goods (ARTG), as described by the criteria in Section 16(1) of the Therapeutic Goods Act 1989. Grouped products represent two or more ARTG entries under a single ARTG number.

ARTG purpose

Relates to the basis of the goods inclusion in the ARTG. Goods are included in the Register as a mechanism indicating approval for supply in Australia and/or approval for export from Australia. Goods for export only will have an ARTG purpose of'export'; all others will have a purpose ofsupply'.

ARTG status

A term which describes the registration /listing status of therapeutic goods in relation to their inclusion, or otherwise, in the ARTG. It includes registered, listed, cancelled by Secretary and cancelled by sponsor.

ATN

Additional trade name

AusPAR

Australian Public Assessment Report

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?)

Australian Approved Name (AAN) for pharmaceutical substances

A name for an ingredient, or a plant or other organism included in the formulation of a medicine, which is included in the list of TGA Approved Terminology for Medicines published by the Therapeutic Goods Administration. The list comprises three parts:

  • Chemical substances AAN list;
  • Herbal substances AAN list; and
  • Biological substances AAN list.
Australian Register of Therapeutic Goods (ARTG)

Maintained under s. 9A of the Therapeutic Goods Act 1989 for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans.

Authorised officer

The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of the Regulations:

  1. an officer of the Department, of another Department or of an authority of the Commonwealth;
  2. an officer of:
    1. a Department of State of a State;or
    2. a Department or administrative unit of the Public Service of a Territory; or
    3. an authority of a State or of a Territory;

being a Department, unit or authority that has functions relating to health matters.

Authorised person

Means:

  1. in relation to any provision of the Act, a person authorised by the Secretary to exercise powers under that provision; or
  2. in relation to a provision of Part 6-2, a member of the Australian Federal Police, or a Customs officer exercising powers in a Customs place (within the meaning of section 183UA of the Customs Act 1901).

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B

Bacterial endotoxin limit

In the context of the microbial quality of prescription and over-the-counter medicines means:

The maximum allowable bacterial endotoxin content in a sterile medicine, as specified by default standard(s).

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
BCS

Biopharmaceutic Classification System

Bioburden

The quantity and characteristics of microorganisms present in, or on therapeutic goods, or to which they may be exposed to during manufacturing.

Biological

A thing that comprises, contains, or is derived from human cells or human tissue; and is represented in any way to be, or is likely to be, for therapeutic use.

Biological medicines

Biological medicines are therapeutic goods that are derived from biological sources and are regulated as registered medicines. They include proteins and polysaccharides such as:

Biological medicines do not include antibiotics and small peptides or molecules <2500 Da.

Biological medicines are distinct from 'biologicals' which are human cell and tissue products.

Biological substance

For the purposes of annual charges is defined in sub-regulation 2(1) of the Therapeutic Goods (Charges) Regulations 1990 as a substance of biological origin that

  1. in many cases, is chemically complex and with a molecular weight of more than 1000; and
  2. is not defined by a chemical name because its purity, strength and exact composition cannot be readily determined by chemical analysis.
Biopharmaceutics

The study of the ways that the physical and chemical properties of drug substances, drug products and routes of administration affect bioavailability (the rate and extent of drug absorption). Biopharmaceutic studies of new medicines typically include the investigation of bioavailability, relative bioavailability and bioequivalence of different dosage forms or formulations, and the effect of food or antacids on their bioavailability.

Biosimilar

Biosimilar is a version of an already registered biological medicine that has a demonstrable similarity in physicochemical, biological and immunological characteristics, efficacy and safety, based on comprehensive comparability studies.

Blinding

Blinding (also called masking) is a procedure in which one or more parties in a clinical trial are kept unaware of the treatment assignment(s). Blinding is used so that neither the patients' nor staff's expectations about the medicine or treatment under investigation can influence the outcome.

British Pharmacopoeia (BP)

See Section 3(1) of the Therapeutic Goods Act 1989. Sponsors should make reference to the latest edition of the BP that has been adopted by the TGA and published as such in the Commonwealth Gazette.

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))

Business name

The name of the person or corporation for which particulars are being supplied or which is making an application. It may be either the name registered with the Australian Securities Investments Commission, or the name of the person or persons who conduct the business. Trading names are not usually included in the business name for Australian applicants, but may be supplied in particular for overseas companies. Also referred to as the Client name / ID. (See also client.)

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C

CAS

Chemical Abstract Services

Case study

In depth description of the factors related to a disease, disorder or condition in a specific individual.

Case-control study

A study that starts with identification of people with the disease, disorder or condition of interest (the cases) and a suitable control group without the disease or outcome (the controls). The relationship of an attribute (medicine, treatment, exposure or risk factor) to the outcome of interest is examined by comparing the frequency or level of the attribute in the cases and in the controls. For example, to determine whether thalidomide caused birth defects, a group of children with birth defects (cases) could be compared to a group of children without birth defects (controls). The groups would then be compared with respect to the proportion exposed to thalidomide through their mothers taking the tablets. Case-control studies are sometimes described as being retrospective as they are always performed looking back in time.

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)

CD

Compact disc

Certificate of a Pharmaceutical Product (CPP)

For medicinal products, the issue of a certificate by the TGA under the World Health Organisation (WHO) Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. It is issued only for therapeutic goods that are medicines. It allows the country of import to ascertain the product's marketing status in Australia and whether it has been manufactured in compliance with GMP.

Certificate of Suitability of a Monograph of the European Pharmacopoeia (CEP)

A certificate provided to the manufacturer by the European Directorate for the Quality of Medicines & HealthCare to certify that the relevant monograph in the European Pharmacopoeia adequately controls the substance as manufactured by the company at the time the certificate was granted.

Certified Product Details (CPD)

A statement of product details, specifications and test methods generated by the sponsor at the request of the TGA.

Charge

The sum payable annually for activities identified under the Therapeutic Goods (Charges) Act 1989 (for example, registration, listing and manufacturing licence).

Chemically derived medicine

A medicine that contains an active ingredient that has been manufactured in whole, or in part, by chemical methods.

CHMP

Committee for Medicinal Products for Human Use

CI

Colour Index

CIOMS

Council for International Organisations of Medical Sciences

Client

A person or organisation having an involvement in the import, export, manufacture or supply of therapeutic goods. An enterprise can include sponsors, manufacturers and agents.

Client ID

Identification code assigned by the TGA to a client

Clinical significance

The quality of a study's outcome that convinces physicians to modify or maintain their current practice of medicine. The assessment of clinical significance is usually based on the size of the effect observed, the quality of the study that yielded the data, and the probability that the effect is a true one. Clinical significance is not the same as statistical significance; a finding in a study may demonstrate a statistical difference in an attribute under review but this may have no impact clinically.

Clinical trial / clinical study (synonym: intervention study)

A planned study in humans designed to discover or verify:

  • the clinical, pharmacological and/or other pharmacodynamic effects of a medicine or treatment; and/or
  • to identify any adverse reactions to a medicine or treatment; and/or
  • to study absorption, distribution, metabolism and excretion of a medicine or treatment,
  • with the object of ascertaining its safety and/or efficacy.
Clock

Refers to recording of working days by TGA.

Closed shelf life

The shelf life of a therapeutic good before opening of the immediate container in which the therapeutic good is supplied.

CLP

Certificate of Listed Product

CMEC

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

Cochrane review

A Cochrane Review is a systematic, up-to-date summary of reliable evidence of the benefits and risks of healthcare. For a review to be called a "Cochrane Review" it must be in the Parent database maintained by the Cochrane Collaboration. The Cochrane Collaboration is an international organisation that aims to help people make well-informed decisions about healthcare by preparing, maintaining and promoting the accessibility of systematic reviews of healthcare interventions.

Cohort study (synonyms: follow-up, incidence, longitudinal, prospective study)

An observational study in which a defined group of people (the cohort) is followed over time. The outcomes of people in subsets of this cohort are compared, (e.g. to examine people who were exposed or not exposed, or exposed at different levels, to a particular intervention or other factor of interest). A cohort can be assembled in the present and followed into the future (this would be a prospective study or a "concurrent cohort study"), or the cohort could be identified from past records and followed from the time of those records to the present (this would be a retrospective study or a "historical cohort study"). Because random allocation is not used, matching or statistical adjustment at the analysis stage must be used to minimise the influence of factors other than the intervention or factor of interest.

Colour

In relation to colourings used in oral medicines means:

An inactive substance that is used in oral formulations of medicines, for various reasons (e.g. To distinguish between strengths, indications or markings).

Combined collection of evidence

Refers to the collection of evidence items to support a primary clinical study or primary item of evidence, and when taken together they address all overarching concepts raised in the checklists for a particular indication.

Common Technical Document (CTD) format

An internationally agreed set of specifications for a submission dossier. The CTD format includes five modules that set out the requirements for a consistent, unambiguous and transparent dossier that can be easily navigated by TGA staff and evaluators. See Common Technical Document overview

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

A medicinal product where the primary pack or the container includes at least two kinds of medicinal products and does not contain any therapeutic devices. The medicinal products must be for use as a single treatment regimen. Examples include a strip or blister pack containing tablets or capsules with differing formulations to be taken in a specified order, or a primary pack containing an active ingredient in one vial and a diluent in another vial, or a primary pack containing separate containers of different formulations for use as part of a single regimen of treatment.

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
Condition

A simplified description for a disorder, disease, ailment, defect or injury.

Conformity assessment

See Australian Regulatory Guidelines for Medical Devices

Consequential change (to the product information)

A required change to the product information as a result of a variation to the Australian Register of Therapeutic Goods entry for that product.

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

Container type

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. Container types are independent of the material used to fabricate them.

Contract manufacture

Where all or part of the manufacturing process of therapeutic goods is carried out by a person other than the sponsor on a contract basis. Can include principal manufacturers and other (sub) manufacturers.

Control

In clinical trials comparing two or more interventions, a control is a person in the comparison group that does not receive the medicine or treatment under evaluation. Instead that person receives a placebo, no intervention, usual care or another form of care. In case-control studies, a control is a person in the comparison group without the disease or outcome of interest.

In statistics, to control means to adjust for or take into account extraneous influences or observations.

Controlled clinical trial

Refers to a study that compares one or more intervention groups to one or more comparison (control) groups. Whilst not all controlled studies are randomised, all randomised trials are controlled.

COPD

Chronic Obstructive Pulmonary Disease

Corporation

Means a body corporate that is:

  1. a foreign corporation; or
  2. a trading corporation formed within the limits of the Commonwealth or a financial corporation so formed.
Corresponding state law

Means a State law declared by the regulations to correspond to this Act or the regulations, including such a law as amended from time to time.

CPMP

Committee for Proprietary Medicinal Products

Critical medical device

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

Crossover trial

This is a research design in which subjects receive a number of treatments in sequence. Generally, this means that all subjects have an equal chance during the trial of experiencing both treatment and placebo dosages without direct knowledge, instead of either placebo or the treatment. Subjects may be transferred directly from one treatment to another or may have a washout period in between test treatments. This type of trial can be randomised so that all subjects don't get the alternative treatments in the same order.

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
CV

Curriculum vitae

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D

Data processing device

Any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device.

DEAL

Device Electronic Application Lodgement (see TGA eBusiness services)

Decision

Has the same meaning as in the Administrative Appeals Tribunal Act 1975.

Default standard

Under sections 3 of the Therapeutic Goods Act 1989 three pharmacopoeias are defined as 'default standards' used to specify the quality, method of manufacture and other aspects of therapeutic goods. These are the British Pharmacopoeia, European Pharmacopoeia and United States Pharmacopeia–National Formulary.

Delegate

A person who has been given authority by the Minister or Secretary of the Department of Health and Ageing to exercise a power, which the Therapeutic Goods Act 1989 or the Regulations confer on the Minister/Secretary. Refer to Section 57 and Regulations 47 and 47A.

Desktop review

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

Diagnostic goods for in vitro use

See Regulation 2 of the Therapeutic Goods Regulations. Relates only to therapeutic devices.

Diluent

In relation to stability testing for prescription medicines means:

A sterile liquid, supplied as a component of some medicines or as a separate product, and intended for use in reconstitution/dilution of the drug product in preparation for administration (e.g. water for injections).

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
Disease

Any deviation or interruption of the normal structure or function of any part, organ or system (or combination thereof) of the body that is manifested by a characteristic set of symptoms and signs and whose aetiology, pathology and prognosis may be known or unknown.

Disorder

A derangement or abnormality of function.

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
DNA

Deoxyribonucleic acid

Do not reuse symbol

symbol meaning DO NOT REUSEThe 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".

Dosage form

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

Dosage regimen

The number of doses per given time period, the time that elapses between doses or the quantity of a medicine that is given at each specific time of dosing.

Double blind

Neither the participants in a trial nor the investigators (outcome assessors) are aware of which intervention the participants are given during the course of the trial.

Drug

See medicine (Section 3(1) of the Therapeutic Goods Act 1989).

Note that legislative definitions apply in both singular and plural forms.

Drug master file (DMF)

Data on the manufacture, quality control and stability of a drug substance sourced from a third-party manufacturer that is used in the manufacture of a medicine.

Drug product

In relation to impurities in drug substances, means the finished formulation of a medicine prior to the final steps in the manufacturing process.

In the context of TGA guidance for prescription medicines, means the finished formulation of a medicine as supplied.

Drug substance

Therapeutically active component in the final formulation of therapeutic goods.

DVD

Digital versatile disc

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E

eBS

eBusiness Services

EC-MRA

Australia - European Community mutual recognition agreement

ECRI classification system (UMDNS/IMDC)

The system devised by the Emergency Care Research Institute of the USA that consists of assigned nomenclature and corresponding 5 digit codes for an extensive range of medical equipment. This system has been renamed by ECRI as the Universal Medical Device Nomenclature System (UMDNS) with codes being called International Medical Device Classifications.

eCTD

Electronic Common Technical Document

EDQM

European Directorate for the Quality of Medicines and Healthcare

EEL

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

Efficacy

A relative concept referring to the ability of a medicine or treatment to achieve a beneficial clinical effect. This may be measured or evaluated using objective or subjective parameters.

EFTA-MRA

Australia - European Free Trade Association mutual recognition agreement

ELF

Electronic Listing Facility (see TGA eBusiness services)

ELISA

Enzyme-linked immunosorbent assay

EMA

European Medicines Agency

Endpoint

An indicator measured in a patient or biological sample to assess safety, efficacy or another trial objective. Also defined as the final trial objective by some authors.

EOI

Extension of indication

EP

European Pharmacopoeia

Epidemiology

The study of the distribution and determinants of health-related states or events in specified populations.

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)

Ethics committee

Means a committee:

  1. constituted and operating as an ethics committee in accordance with guidelines issued by the CEO of the National Health and Medical Research Council as in force from time to time; and
  2. which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.
EU

European Union

EU/ICH

European Union/International Congress on Harmonisation

EudraLex

The Rules Governing Medicinal Products in the European Union

Excipient

Any component of a finished dosage form other than an active ingredient (in some cases the distinction between an active ingredient and an excipient may not be clear cut, for example: sodium chloride used to adjust tonicity of an injection is an excipient).

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

Exempt person

In relation to therapeutic goods, means a person exempted from the operation of Part 3-3 in relation to those goods by the Regulations.

Experimental purposes in humans

As used in the Therapeutic Goods Act and Regulations, refers to use of medicines or devices in clinical trials subject to approval under Section 19(1)(b) of the Therapeutic Goods Act or to notification under item 3 of Schedule 5A of the Regulations.

Export certificate (devices)

A certificate issued for therapeutic devices equivalent to the WHO Certificate of a Pharmaceutical Product.

Export certification

See Section 58 of the Therapeutic Goods Act. Can include a WHO Certificate of a Pharmaceutical Product for medicines, a Certificate of Free Sale (Devices) or an Export Certificate (Devices).

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)
Evidence-based textbook

A textbook based on a critical and systematic review of published data, not simply on the opinions of the author(s).

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F

FDA

USA Food and Drug Administration

Fee

A sum payable for activities or events identified in Schedule 9 of the Regulations to the Therapeutic Goods Act 1989 (for example, evaluation fee).

FFS

Form Fill Seal

Fill volume

Agreed specification of the target volume of a drug product in the final container.

Financial corporation

means a financial corporation within the meaning of paragraph 51(xx) of the Constitution.

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

FOI Act

The Freedom of Information Act 1982.

Foreign corporation

Means a foreign corporation within the meaning of paragraph 51(xx) of the Constitution.

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)

GC

Gas Chromatography

Generic medicine

The Therapeutic Goods Regulations 1990, Regulation 2, defines a generic medicine as'a medicine that, in comparison with 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 or previously registered medicine; and
  2. has the same pharmaceutical form; and
  3. is bioequivalent; and
  4. has the same safety and efficacy properties
Genetically modified organism (GMO)

The Gene Technology Act 2000 defines a GMO as:

  1. an organism that has been modified by gene technology; or
  2. an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
  3. anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;

but does not include:

  1. a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
  2. an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms.
Genetically modified product

The Gene Technology Act 2000 and the Office of the Gene Technology Regulator defines a genetically modified product.

GHTF

Global Harmonization Task Force

Global Medical Device Nomenclature (GMDN)

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.

GLP

Good Laboratory Practice

GM

Genetically Modified

GMP clearance

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

Good clinical practice

A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.

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)

Grouping

In relation to guidance on fees and charges for prescription medicines means:

The mechanism whereby goods, which would normally be required to be included in the ARTG under different ARTG registration or listing numbers (because they are separate and distinct by virtue of S 16(1) of the Therapeutic Goods Act 1989, may be included in the ARTG under the one ARTG registration or listing number, thereby attracting a single annual charge for the group of goods. Each product (as defined by S 16(1)) is still regarded as a separate ARTG entry and all controls under the Therapeutic Goods Act 1989 apply discretely to each separate and distinct product (for example: application fees; conditions; cancellation).

GTRAP

Gene and Related Therapies Research Advisory Panel

Guide to good manufacturing practice for medicinal products

A publication that outlines good principles and practices to be followed in the manufacture of therapeutic goods, to provide assurance of product quality and compliance with products entered in the Australian Register of Therapeutic Goods.

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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 preparation

TG Act - a preparation:

  1. manufactured from a mother substance; and
  2. manufactured in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia.

TG Regs - 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

HPLC

High Performance Liquid Chromatography

HREC

Human research ethics committee

HRT

Hormone replacement therapy

Human embryo

A live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro-nuclei or the initiation of its development by other means

Human embryonic stem cell

Undifferentiated cells, derived from a human embryo, that have the potential to become a wide variety of specialised cell types

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I

ICH

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

ICRP

International Commission on Radiological Protection

Identified impurity

In relation to impurities in drug substances is an impurity for which a structural characterisation has been achieved, as defined in Note for guidance on impurities testing: impurities in new drug substances ICHQ3A(R) (CPMP/ICH/2737/99).

Immediate family

In relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person as defined in Regulation 2 of the Therapeutic Goods Regulations.

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

Individual patient data

In relation to therapeutic goods, means information, derived from clinical trials, relating to individuals before, during and after the administration of the goods to those individuals, including, but not limited to, demographic, biochemical and haematological information.

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

Inhalation and nasal medicines

In relation to guidance on inhalation and nasal medicines applies to:

Medicinal products intended for delivery of the drug substance into the lungs, or to the nasal mucosa, with the purpose of evoking a local or systemic effect, as defined in Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products (EMEA/CHMP/QWP/49313/2005).

Initial decision

Means a decision of the Secretary or of a delegate of the Secretary. Section 60 of the Act sets out the types of decisions that are considered 'initial decisions'.

INS

International Numbering System (for food additives)

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

IPD

Individual patient data

IR

Infra Red

IRIS

Incident Report Investigation Scheme

ISO

International standard

IVD or IVDD

In vitro diagnostic device

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J-K

JETACAR

Joint Expert Technical Advisory Committee on Antibiotic Resistance

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
LAL

Limulus amoebocyte lysate

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

In relation to listed goods, means any combination of numbers, symbols and letters assigned to the goods under section 27 of the Act. See Aust L number.

Locally acting products

As used in Biopharmaceutic studies guidance for prescription medicines:

Products which are applied locally, and are assumed to exert their effect at the site of application; systemic action, if any, would be considered as an undesired effect.

Examples are:

  • dermatological products (e.g. Creams, ointments);
  • inhalatory products (e.g. Powders or aerosols for inhalation);
  • eye drops;
  • ear drops;
  • nasal products;

but also orally, vaginally, or rectally applied products which act locally.

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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

Major variation

In relation to guidance on fees and charges for prescription medicines means a change to:

  1. the strength, as recorded in the entry in the Register; or
  2. the dosage, the recommended dose regimen or the maximum daily dose; or
  3. the dosage form; or
  4. the route of administration; or
  5. the intended patient group.
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 certificates
  • Certificate of GMP Compliance
  • GMP Certificate of Manufacturing Facility
  • Certificate of GMP Compliance of a Manufacturer
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 principles

The Minister may, from time to time, determine written principles to be observed in the manufacture of therapeutic goods for use in humans. The manufacturing principles may relate to:

  1. the standards to be maintained, and the equipment to be used, at premises used for the manufacturing of therapeutic goods for use in humans; or
  2. procedures for quality assurance and quality control to be employed in the manufacturing of therapeutic goods for use in humans; or
  3. the qualifications and experience required of persons employed in the manufacture of therapeutic goods for use in humans; or
  4. the manufacturing practices to be employed in the manufacturing of therapeutic goods for use in humans; or
  5. other matters relevant to the quality, safety and efficacy of therapeutic goods for use in humans that are manufactured in Australia;

and may include codes of good manufacturing practice. See Section 36 of the Therapeutic Goods Act 1989.

Manufacturing site

Premises that are for use in the manufacture of a particular kind of therapeutic good, and at which the same persons have control of management of production of the goods and procedures for quality control.

Material of animal or human origin

Any component derived from animals or humans that is contained in, or involved in the manufacture of, the therapeutic goods, including:

  • cell lines;
  • embryonated chicken eggs;
  • materials used in cell culture media;
  • deer velvet antler;
  • amino acids; and
  • some excipients such as gelatin.
MCB

Master Cell Bank

MDEC

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

MEC

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

Medical device

See What is a medical device

Medical practitioner

A person who is registered, in a State or internal Territory, as a medical practitioner.

Medicinal component

The name applied by the ARTG to any one item within a composite pack.

Medicinal product

An alternative term to medicine for the finished, packaged goods.

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
Meeting

A planned meeting that is requested by a sponsor or applicant, including meetings conducted in any format (i.e. face to face, teleconference or videoconference).

Minor variation

For therapeutic goods of a particular kind, means a change (other than a change that is a major variation) to:

  1. the formulation, composition or design specification; or
  2. the container for the goods; or
  3. any other attribute of the goods that results in the goods being separate and distinct.
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

MS

Mass Spectrometry

Multidose use

Intended for use on more than one occasion.

Mutual Recognition Convention

The Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products, founded in Geneva on 8 October 1970. Commonly known as the Pharmaceutical Inspection Convention (PIC).

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N

Name

As used in relation to differentiation between therapeutic goods in Section 16 of the Therapeutic Goods Act 1989. May include the brand name, a descriptor of the goods or generic name together with a sponsor name or logo or banner name of a product range, that is, all elements which, together, serve to make the product recognisable as a particular item of commerce or supply.

Name of the goods

The non-proprietary name including the name of the dosage form or a synonym for the name of the dosage form, used to describe the goods in a specific standard. Listing and registration names include the name of the goods but may include further information to differentiate between forms of presentation.

Natural origin

In the context of the microbial quality of prescription and over-the-counter medicines means: a medicine that contains a raw material(s) of natural origin (animal, vegetal or mineral) where the raw material has not been fully processed.

NBE

New Biological Entity

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))

NeeS

Non-eCTD electronic submission dossier

New chemical entity (NCE)
  1. A chemical, biological or radiopharmaceutical substance that has not previously been included in the ARTG; or
  2. an isomer, mixture of isomers, complex, derivative or salt of a registered chemical substance that, having previously been included in the ARTG, differs from the registered substance in having different safety or efficacy properties; or
  3. a biological substance that, having previously been included in the ARTG, differs from the registered substance:
    1. in having a different molecular structure; or
    2. in deriving from source material of a different nature or from a different manufacturing process; or
  4. a radiopharmaceutical substance that
    1. is a radionuclide or ligand that has not previously been included in the ARTG; or
    2. has a coupling mechanism, linking the molecule and radionuclide, that has not previously been included in the ARTG; or
  5. a fixed combination of active substances that have not previously been included in the ARTG as that fixed combination.
New safety data

Information that might negatively influence the benefit-risk assessment of a medicine or would be sufficient to consider changes in medicinal product administration

NHMRC

National Health and Medical Research Council

NICNAS

National Industrial Chemicals Notification and Assessment Scheme

Non-clinical

The preclinical, pharmaco-toxicological and pharmacological or toxicological studies.

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)

Nontransparent monograph

In relation to impurities in drug substances is a monograph that either does not have a test for impurities or, if it does have such a test, does not list those impurities.

Notification

Advice to the TGA in accordance with the requirements of:

  • Section 29A (information about registered goods different from previously given);
  • Section 29B (adverse effects of goods -registration application withdrawn);
  • Section 9D (variation to goods which may be notified as specified in guidelines);
  • Schedule 5A item 3 (clinical trial);
  • Regulation 13 (change in sponsorship);
  • Regulation 21 (change in QC manager -licensed promises);
  • Regulation 22 (change of licence holder).

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O

Objectionable microorganism

In relation to guidance on microbial quality of prescription and over the counter medicines means:

A microorganism that is not specified in Therapeutic Goods Order No. 77 - Microbial standards for medicines, or in the default standards, but which might pose a risk if it is present in a medicine.

OCM

[TGA] Office of Complementary Medicines

ODBT

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

OECD

Organisation for Economic Co-operation & Development

Official analyst

A person who has appropriate qualifications and experience to be an official analyst for the purposes of the Regulations approved by the Secretary under regulation 25 of the Therapeutic Goods Regulations.

Official sample

A sample of goods taken under the provisions of Part 5 of the Therapeutic Goods Regulations. A certificate of official analyst is issued.

OGTR

Office of Gene Technology Regulator

OLSS

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

OMA

Office of Medicines Authorisation (formerly Office of Prescription Medicines and Office of Non-Prescription Medicines)

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))

ONPM

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

Open shelf life

The shelf life of a therapeutic good once the immediate container, in which the therapeutic good has been supplied, has been opened.

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

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))

Orphan drug

A medicine, vaccine or in vivo diagnostic agent that meets the requirements of regulation 16H of the Therapeutic Goods Regulations 1990. The requirements include that it:

  1. must be intended to treat, prevent or diagnose a rare disease; or
  2. must not be commercially viable to supply to treat, prevent or diagnose another disease or condition.

See section 16H of the Therapeutic Goods Regulations 1990 for full definition.

OTC

Over-the-Counter (medicines)

OTGs

Other therapeutic goods

Overage

Increased content of drug substance, usually due to loss of potency on storage.

Overfill

Increased volume of drug product to account for loss during delivery.

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P

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)

Packaging

In relation to guidance about drug master files and certificates of suitability:

Secondary packaging means any packaging or labelling process (including repackaging and labelling, overlabelling and supplementary labelling) where the medicine is already in the primary container, and that primary container is not opened, breached or modified in the secondary packaging process.

Primary packaging means any other type of packaging operation.

Note that primary and secondary packaging requires different levels of good manufacturing practice certification.

PAR

Provisional ARTG record

Parliamentary Secretary

The Parliamentary Secretary for Health, who assists the Minister for Health by assuming responsibility for the TGA.

Partially processed goods

Therapeutic goods whose manufacture has not been completed to the stage of final packaging and labelling.

Patient information document

See Consumer Medicine Information.

PDF

Portable document format

PET

Positron emission tomography

Ph. Eur.

European Pharmacopoeia

Pharmaceutical benefit

A Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans' Entitlements Act 1986 as defined inRegulation 2 of the Therapeutic Goods Regulations.

PIC/S

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

Placebo

An inactive substance or treatment that supposedly has no treatment value. It is given to participants in clinical trials as a control against which to compare the effects of the test substance. In practice, placebos may also have positive or negative effects on trial participants.

Plasma master file

A compilation of all the required scientific data on the quality and safety of human plasma relevant to medicines, medical devices and investigational products that use human plasma in their manufacture. These data cover all aspects of the use of plasma, from collection to plasma pool.

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))

Poisons Schedule

A schedule of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).

Poisons Standard

The legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), it is a Legislative Instrument consisting of decisions regarding the classification of medicines and poisons into Schedules. Scheduling is a national classification system that controls how medicines and poisons are made available to the public. Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison, required to protect public health and safety.

Population studies

Investigations of a disease or condition using subjects from a defined population. A population is a closely distributed grouping from a single community that is characterised by both genetic and cultural continuity through several generations.

Potentially hazrdous

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

PPF

Pre-submission planning form

Premises

Includes:

  1. a structure, building, aircraft, vehicle or vessel; and
  2. a place (whether enclosed or built upon or not); and
  3. a part of a thing referred to in (a) or (b).
Prescribed quality and safety criteria

See Section 26(1)(k) of the Therapeutic Goods Act 1989. Quality and safety requirements prescribed in the Regulations for particular listable goods or categories of listable goods.

Presentation

In relation to guidance on inhalation and nasal medicines means:

The way in which therapeutic 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.

Primary outcome

Is the outcome variable that is designated as the key in the design or analysis of the trial results.

Primary pack

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

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

Prions

Small proteinaceous infectious particles that resist inactivation by procedures that modify nucleic acids. Some prions can cause transmissible spongiform encephalopathies.

Problem report

Report of a suspected deficiency of quality, safety or efficacy in a therapeutic good.

Procedure pack

See Australian Regulatory Guidelines for Medical Devices

Product

The commercial presentation or marketed entity of therapeutic goods, excluding pack size.

Product Information (PI)

Product information is defined in s3 of the Therapeutic Goods Act 1989 to mean:

'in relation to therapeutic goods, information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods'.

Product material

This term is used in ARTG application forms and guides when asking for copies of information provided about the goods for medical practitioners and/or patients/users. It includes Consumer Medicine Information (CMI), Product Information (PI) and promotional material.

Product name - medicines

The proprietary name as shown on the label or where there is no proprietary name, the registration/listing name.

Product number

Reference number assigned by ARTG to each product grouped under one registration or listing.

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

As defined in Therapeutic Goods Order No. 69 General requirements for labels for medicines (2001) means the registered trademark of the therapeutic goods or the unique name assigned to the goods by the sponsor and appearing on a label.

Proprietary research

Proprietary research is commissioned research (e.g. clinical trials sponsored by a drug company) undertaken on the basis that the proposal, data and results will remain confidential for a specified length of time. Some companies conduct their own proprietary research; others request and fund research by academic and other research institutions.

Protocol

All clinical trials are based on a protocol, which describes who may participate in a trial, the length of a trial and the schedule of tests, procedures, medications and dosages.

PSC

Pharmaceutical Subcommittee (of ACPM)

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Q

QA

Quality assurance

QMS

Quality Management System

QSAR

Quantitative structure activity relationships

Qualification

In relation to impurities in drug substances, the process of acquiring and evaluating data that establish the biological safety of an individual impurity or a given impurity profile at the level(s) specified.

Qualification threshold

In relation to impurities in drug substances, a limit above which a degradation product should be qualified

Quality

In relation to therapeutic goods, includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction, and performance characteristics of the goods.

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R

Radiopharmaceutical

Radiopharmaceutical products comprise:

  • ready-for-use radiopharmaceuticals, including positron emission tomography (PET) radiopharmaceuticals;
  • nonradioactive components (kits and chemical precursors, including those for PET) for combination with a radioactive component (e.g. eluate from a radionuclide generator or a cyclotron-produced radionuclide);
  • radionuclide generators;
  • radionuclide precursors used for radiolabelling other substances before administration.
Randomisation

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

Randomised controlled trial (RCT)

An experiment in which investigators randomly allocate eligible people into intervention groups to receive or not to receive one or more interventions that are being compared. The results are assessed by comparing outcomes in the treatment and control groups.

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)

Recall for product correction

The repair, modification, adjustment or relabelling of therapeutic goods for reasons relating to deficiencies in the quality, safety or efficacy of the goods.

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

Registration/listing name - medicines

The name which will appear on the Certificate of Registration/Listing. The Registration/ Listing name is a fully descriptive name which enables clear identification of the goods as they are presented for supply. Where goods have a name which applies to more than one product, the name must be followed by sufficient details to enable unique identification. It includes: the proprietary name (if any); and the non proprietary name; or a descriptive name which includes a commercial identifier such as sponsor name; and must include the dosage form, and where appropriate, the strength and container type.

Related impurities

In relation to impurities in drug substances, an organic impurity sharing structural features with the drug substance formed either during the synthesis of the drug substance ('synthetic impurities') or during storage ('degradants'), excluding impurities derived from catalysts, solvents and reagents.

Relevant test
  1. In relation to the analysis of therapeutic goods (other than medical devices), means a test that, under sub regulation 28 (1), is a relevant test to determine whether the goods conform with an applicable standard applicable to the goods; and
  2. in relation to the analysis of a medical device, means a test that, under sub regulation 28 (2), is a relevant test to determine whether a medical device complies with the applicable provisions of the essential principles.
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
Responsible analyst

In relation to the analysis of a sample of therapeutic goods, means an official analyst who is nominated as a responsible analyst for the sample under paragraph 25 (3) (c) of the Therapeutic Goods Regulations.

Restricted medicine

Defined in the Restricted Medicine Specification 2011 and include medicines that are regulated as prescription medicines (see Schedules 4 and 8 of the current Poisons Standard) and medicines that are only available from a pharmacist (Schedule 3 of the current Poisons Standard).

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)

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.

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

Reviewable decision

A decision of the Minister under section 60(3) of the Act. Subject to paragraph 60A(2)(b) of the Act, the Minister must, as soon as practicable after receiving a request under subsection (2), reconsider the initial decision and, as a result of that reconsideration, may:

  1. confirm the initial decision; or
  2. revoke the initial decision, or revoke that decision and make a decision in substitution for the initial decision.
RMP

Risk management plan

Route of administration

Route by which a therapeutic good is applied on or introduced into the body

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S

Safety related request

A safety-related request to vary an entry in the Australian Register of Therapeutic Goods is one where the variation has one of two possible outcomes:

  • to reduce the patient population (e.g. remove an indication or limit the use of the medicine); or
  • to have the effect of adding a warning or precaution (e.g. an adverse effect or interaction).

Safety-related requests are made under s. 9D(2) of the Therapeutic Goods Act 1989.

SAL

Sterility assurance level

Samples officer

An officer of the Department performing duties under the direction of an official analyst. As defined in Regulation 23 of the Therapeutic Goods Regulations.

SAN

Self assessable notification

SAR

Self-assessable request

SAS

Special Access Scheme

Schedule 10 medicines

A medicinal product of a type described in Schedule 10 of the Therapeutic Goods Regulations. Medicines in Part 1 of Schedule 10 are evaluated by the Drug Safety and Evaluation Branch of TGA.

Secondary outcome

Is the less clinically important when compared to the primary study outcome.

Secretary

Means the Secretary of the Department of Health

Self-manageable

Indicates whether the diagnosed condition is beyond the ability of the average consumer to evaluate accurately and manage safely without the supervision by and assistance from a suitably qualified health care professional.

Self-preserving

A formulation that does not require addition of a preservative(s) to meet the preservative efficacy criteria.

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.

Semisynthetic drug substance

A substance in which the structural constituents have been introduced by a combination of chemical synthesis and elements of biological origin (e.g. obtained from fermentation or by extraction from botanical material).

Separate and distinct goods

A therapeutic good is taken to be separate and distinct from other therapeutic goods if it has:

  • a different formulation, composition or design specification; or
  • a different strength or size (disregarding pack size); or
  • a different dosage form or model; or
  • a different name; or
  • different indications (except for variations to indications under s. 9D(2) of the Therapeutic Goods Act 1989, as described in s. 9D(2A).); or
  • different directions for use; or
  • a different type of container (disregarding container size).
Serious AE/ADR

See Guidelines on the reporting of adverse drug reactions by drug sponsors: Definitions

Service goods

Therapeutic goods which are required in the public interest but whose supply does not offer financial incentive for the sponsor.

Shelf life

The time period during which a therapeutic good is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.

Sign

Any objective evidence of a disease, that is, such evidence as is perceptible to the examining physician, as opposed to the subjective sensations (symptoms) of the patient.

SIME

Strategic Information Management Environment - now called TGA eBusiness services

Similar Biological Medicinal Product (SBMP)

Similar biological medicinal product may be used interchangeably with biosimilar.

Single blind

A clinical trial where the participants are unaware of the whether they are receiving the placebo or active medicine or treatment.

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 step of manufacture

For the purpose of annual licence charge classification only - for example one of the following: tablet coating; capsule filling from bulk; aerosol filling from bulk; storage other than for sale; packaging including labelling; sterilisation; testing including analysis; assembling devices from components, testing or batch testing of therapeutic devices; releasing for sale (by a person not involved with actually preparing the goods).

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

Site

This refers to the place where a clinical trial is conducted. When a clinical trial is conducted at more than one site, but using the same protocol, it is referred to as a multi-site or multi-centre trial.

Site identification

Identification code assigned by the Manufacturer Assessment Section (MAS) to a manufacturing site(s) for an enterprise which is involved with the manufacture of therapeutic goods.

SMF

Site Master File

SPC

Summary of product characteristics

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
Specified microorganism

An indicator microorganism that is identified in TGO 77 and in the default standards (i.e. Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella, bile-tolerant gram-negative bacteria and Candida albicans).

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:

  1. exports, imports or manufactures the goods; or
  2. 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.

Standard

See Section 3(1) of the Therapeutic Goods Act 1989. Must be specified in a TGO or the BP. A general standard that applies to all products of a particular dosage form. A specific standard of medicines refers to a particular dosage form of particular active ingredient(s).

State law

A law of a State, of the Australian Capital Territory, or of the Northern Territory.

Statistical significance

The probability that an event or difference is real or occurred by chance alone. It does not indicate whether the difference is small or large, important or trivial. The level of statistical significance depends on the number of patients studied or observations made, as well as the magnitude of difference observed. Statistical significance observed in a clinical trial does not necessarily imply clinical significance.

Step in manufacture

Any part of the process of bringing goods to their final state which may be completed separately from other parts of the process.

Strength

The quantity of an active pharmaceutical ingredient in a medicine or a formulated or medicated device.

Sub-manufacturer

A manufacturer who completes part of the manufacturing process of therapeutic goods on behalf of the principal manufacturer (no longer used in the ARTG system - replaced by manufacturer with an identified step in manufacture).

Subject / trial subject

An individual who participates in a clinical trial, either as a recipient of the medicine or treatment, or as a control.

Submission

A series of related applications made under the Therapeutic Goods Act on the same day for the same active ingredient, lodged by the same sponsor.

Summary of product characteristics (SmPC)

European equivalent to the Australian product information (PI).

Supplier

A person or organisation that is involved in the supply and distribution of the product, but not involved in product manufacture.

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)

Surrogate

A surrogate endpoint (or marker) is a measure of effect of a certain treatment that may correlate with a real clinical endpoint but doesn't necessarily have a guaranteed relationship. The National Institutes of Health (USA) define surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint".

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)

Symptom

Any subjective evidence of disease or of a patient's condition, that is, such evidence as perceived by the patient.

Syndrome

A set of symptoms which occur together; a symptom complex.

Systematic review

An analysis of a large number of clinical trials (sometimes known as a 'meta-analysis') aimed at looking for an overall pattern in the trial results. Cochrane Reviews are examples of such systematic reviews. In a systematic analysis only those trials which meet a number of pre-set conditions in relation to research design (e.g. sample size, randomisation) are included in the final meta-analysis.

Systems [regulated devices]

See Australian Regulatory Guidelines for Medical Devices

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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

TGA Approved Terminology for Medicines

A compendium document which (in the main) identifies terms to be used when making an application to the TGA for registration of medicines.

TGACC

Therapeutic Goods Advertising Code Council

TGC

Therapeutic Goods Committee

TGO

Therapeutic goods order

Therapeutic goods

Goods:

  1. 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:

    1. for therapeutic use; or
    2. for use as an ingredient or component in the manufacture of therapeutic goods; or
    3. for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or
  2. 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 biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include:

  1. goods declared not to be therapeutic goods under an order in force under section 7; or
  2. 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
  3. 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
  4. 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.
Therapeutic Goods Advertising Code (TGAC)

See Therapeutic Goods Advertising Code

Therapeutic goods information

Means information in relation to therapeutic goods that is held by the Department and relates to the performance of the Department's functions (including functions relating to the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement).

Therapeutic Goods Order (TGO)

An Australian standard that relates to a particular type of therapeutic good, or specifies particular requirements for labelling, packaging or other aspects.

Therapeutic use

See What are 'therapeutic goods'?

TICC

TGA-Industry Consultative Committee

Topical

Applied to a certain area of the skin for a localised effect

Trade name

For therapeutic goods of a particular kind, means the commercial name:

  1. given to goods of that kind by the manufacturer; and
  2. under which the goods are supplied. See Regulation 2 of the Therapeutic Goods Regulations 1990.
Trading corporation

Means a trading corporation within the meaning of paragraph 51(xx) of the Constitution.

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

Transdermal

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

Transparent monograph

Lists the impurities controlled by that monograph by name and/or chemical structure.

TSE

Transmissible spongiform encephalopathies

TTC

Threshold of toxicological concern

TWG

Technical Working Groups [manufacturing]

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UK

United Kingdom

Unidentified impurity

In relation to impurities in drug substances and drug products means:

An impurity for which structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (e.g. chromatographic retention time), as defined in Note for guidance on impurities testing: impurities in new drug substances ICHQ3A(R) (CPMP/ICH/2737/99)

Unrelated impurity

In relation to impurities in drug substances are impurities other than related impurities.

URPTG

Uniform Recall Procedure for Therapeutic Goods

USA

United States of America

USB

Universal serial bus

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

USP-NF

United States Pharmacopeia-National Formulary

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V-W-X-Y-Z

Variation

A change to an Australian Register of Therapeutic Goods entry.

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
Warning or precaution

One or more statements in the product information (PI) that draw attention to potential adverse effects resulting from product use.

Washout period

The stage in a cross-over trial where treatment is withdrawn before a second treatment is given. This is usually necessary to counteract the possibility that the first substance can continue to affect the subject for some time after it is withdrawn.

WCB

Working Cell Bank

WHO

World Health Organization

Working day

For the evaluation of applications, means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory; Otherwise means any day except: (a) Saturday or Sunday; or (b) a day that is a public holiday in the State or Territory in which the person is located.

Web page last updated: Wednesday, 23 April 2014

URL: http://www.tga.gov.au/about/glossary.htm