Administrative Appeals Tribunal

Advisory Committee on Biologicals

Advisory Committee on Complementary Medicines

Advisory Committee on Medicines

Advisory Committee on Medicines Scheduling

The Therapeutic Goods Act 1989

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

Means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the production of a medicine, becomes an active ingredient of that medicine. These substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. Defined in Therapeutic Goods (Manufacturing Principles) Determination 2020.

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

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

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.

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)

Australian Health Ethics Committee

Approved Herbal Name (see TGA approved terminology for medicines)

Australian Influenza Vaccine Committee

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

In relation to a medicine, means a shortage of the medicine that is anticipated to commence at a future date.

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.

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.

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).

The term Application in relation to TGA's medicine registration process is the top group of a series of sequences for the same product (e.g. active ingredient). One Application is usually defined for the complete life cycle of the specific product. (See also eCTD).

Australian Regulatory Guidelines for Advertising Therapeutic Goods

Australian Regulatory Guidelines for Medical Devices

Australian Regulatory Guidelines for Prescription Medicines

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'.

In relation to cyber security: the different points (code, components, user functions, etc.) where a medical device is exposed to adversaries or other unauthorised modifications.

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

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.

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.

Living tissue transferred from one part of a patient's body to another

In relation to human cell and tissue products, the basic functions of the product are:

• those that are well understood (scientifically) to apply to the donor tissue

AND

• where functionality can be assumed in the recipient, in the absence of a need to perform testing

Biopharmaceutic Classification System

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

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.

In relation to cyber security: groups or individuals who assess a target system to find its vulnerabilities (known or new), implement ‘exploits’ for these vulnerabilities and use exploits to attack the system with malicious motivation.

Whole blood collected from a single human donor and processed either for transfusion or further manufacturing

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.

Bovine spongiform encephalopathy (see Transmissible spongiform encephalopathies (TSEs))

Corrective and Preventative Action

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

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)

Compact disc

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.

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

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

Colour Index

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.

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.

Refers to recording of working days by TGA.

Certificate of Listed Product

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.

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.

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).

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

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

see Australian Regulatory Guidelines for Medical Devices

Expert groups that provide assistance in handling cyber security incidents.

In relation to a person, any deviation(s) from the normal structure or function of the body, as manifested by a characteristic set of signs and symptoms.

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

Goods intended for personal, domestic or household use

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

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.

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.

Blood which contains many different types of cells, including stem cells, taken from the umbilical cord

Action to eliminate a detected deficiency or nonconformity. A correction can be made in advance of, or in conjunction, with a corrective action. There is a distinction between corrective action and correction. Corrective actions are taken to prevent reoccurrence, whereas corrections are made against individual examples of a core issue. A correction can be, for example, rework or regrade. (Based on ISO 9000 Clause 3.12.3).

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.

Critical process parameter - a process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality (ICH Q8).

Means all materials or supplies used in the manufacture of therapeutic goods which could have a direct impact on the quality, safety or function of the final goods

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.

Clinical trial approval scheme (see Clinical trials)

We can give time limited provisional approval to medicines which provide promise of a major therapeutic advance for the treatment of serious or life threatening conditions. The initial provisional registration is for two years with the possibility of two extensions of up to two years each. This makes the medicine available while the pharmaceutical company completes final clinical trials. As a condition of provisional registration, the company must agree to continue clinical trials and submit comprehensive evidence for review to the TGA. If they do not follow this plan, or submit this evidence, we can cancel the approval, or may not extend the provisional registration period in the interest of patient safety. The current provisional lapse date is the date the provisional registration expires, however it may be extended within the maximum six year period. It is anticipated that in general, provisionally registered medicines will transition to a standard, registration.

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

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.

For a biological: the date (day, month and year) on which the processing of the product, including the packaging, is completed

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

Non-fulfilment of a requirement; term is used in GMP manufacturing inspections (based on ISO 9000 Clause 3.6.2).

The process of removing minerals (e.g. calcium salts from bone) from tissue

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

In relation to a patient, means continuous surveillance by direct measurement

In relation to a medicine, means that the sponsor has decided to cease supply of the medicine to the Australian market.

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

Deoxyribonucleic acid

A person who, by receiving an organ or tissue transplant, donates the removed organ or tissue to another recipient

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

A collection of files and documents that contains data (administrative, quality, nonclinical and clinical) relating to a therapeutic good.

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.

being replaced by 'active substance'; synonym for 'active pharmaceutical ingredient'

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.

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

Australia - European Free Trade Association mutual recognition agreement

Enzyme-linked immunosorbent assay

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.

European Pharmacopoeia

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)

European Union

The Rules Governing Medicinal Products in the European Union

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).

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

As 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.

In relation to cyber security: an instance where a vulnerability or vulnerabilities have been exercised (accidently or intentionally) by a threat and could impact the safety or essential performance of a medical device or use a medical device as a vector to compromise a connected device or system.

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).

in relation to the recall of therapeutic goods, means the frequency with which the failure occurs for the affected stock

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

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

Medicinal product when all stages of manufacture except for release for supply have been completed.

The Freedom of Information Act 1982.

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

Gas Chromatography

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.

Global Harmonization Task Force

Good Laboratory Practice

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

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.

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

Hepatitis B surface antigen

Herbal component name

Hepatitis C virus

Human Immunodeficiency Virus

Is use of human cells or tissues to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected (donor).

For more information: Intended use: interpretation of homologous use

Haematopoietic progenitor cells-cord

Haematopoietic progenitor cells: cells that are primitive multipotent cells capable of self-renewal as well as differentiation and maturation into all haematopoietic lineages

Human research ethics committee. More information: National Health and Medical Research Council

Human T-lymphotropic viruses type 1

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

ICH Harmonised Tripartate Guidance Structure and Content of Clinical Study Reports

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).

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

Means the specific therapeutic uses of the goods

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

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'.

Systematic, independent and documented process for obtaining inspection evidence and evaluating it objectively to determine the extent to which the inspection criteria are fulfilled (based on ISO 19011 - Clause 3.1).

Set of policies, procedures or requirements (based on ISO 19011 - Clause 3.2) used as a reference against which inspection evidence is compared.

Results of the evaluation of the collected inspection evidence against inspection criteria (based on ISO 19011 - Clause 3.4).

The documented verification that the facilities, systems and equipment, as installed and modified, comply with the approved design and the manufacturer's recommendations.

Partly processed material from a manufacturer with a current TGA licence or GMP clearance that must undergo further manufacturing steps before it becomes a bulk product.

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

Infra Red

International standard

Limulus amoebocyte lysate

A condition where the prominent feature (i.e. affecting an important portion of the target population) is serious illness 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 treatment based on mortality and life expectancy data.

Therapeutic goods that are included in the part of the ARTG for goods known as Listed goods

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.

An improvement in the safety and/or efficacy of the medicine that is of a magnitude well beyond the minimum threshold of clinical significance.

The impact on patient outcomes for the indicated population will take into account effects on both efficacy and safety. The magnitude of the demonstrated improvement in safety and/or efficacy will be assessed in relation to other therapeutic goods registered for the indicated population. For provisional determination or registration this means that there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance.

In relation to cyber security: software designed with malicious intent to disrupt normal function of a system or device, gather sensitive information, and/or access other connected systems.

Corporation or person carrying out one or more of the steps specified in the definition of manufacture

A certificate issued by a regulatory authority to a specific manufacturing site, outlining the manufacturing operations for which the site is authorised and stating the GMP compliance status of the site at a particular point in time.

Examples of manufacturing certificates:

• Certificate of Good Manufacturing Practice (GMP)
• Certificate of GMP Compliance of a Manufacturer
• GMP Certificate

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.

The approval given to supply a therapeutic good in Australia, involving entry on the ARTG.

The marketing authorisation includes the details of the product in the ARTG, as well as all other matters in relation to product registration, listing or inclusion agreed in writing between TGA and the sponsor, and any other requirements imposed by a relevant Delegate of the Secretary upon ARTG entry.

Master Cell Bank

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

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

a product that is a medicine

A medicine shortage occurs when the supply of a medicine in Australia is unlikely to meet normal demand for consumers who need to take the medicine for a period of time.

The legal definition is as follows:

There is a shortage of a medicine in Australia at a particular time if, at any time in the 6 months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.

Microorganisms including, but not limited to, bacteria, fungi, Mycoplasma and Rickettsia

Contamination of the product already present in the starting material

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.

Memorandum of Intention

Memorandum of Understanding

Mass Spectrometry

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.

New Biological Entity

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

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.

A prescription medicine that contains:

1. a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the ARTG; or
2. a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the ARTG

National Health and Medical Research Council

In relation to eCTD, additional heading structures beyond those defined by the specifications - generally equated to an additional subfolder in a defined section.

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)

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

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.

Data supporting the existence or verity of something (ISO 9000 Clause 3.8.3). Objective evidence can be obtained through observation, measurement, test, or other means. For the purpose of an inspection, objective evidence generally consists of records, statements of fact or other information, which are relevant to the inspection criteria and verifiable.

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

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.

Office of Gene Technology Regulator

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

[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))

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

out-of-trend - test results that are within specification or acceptance criteria, but fall outside the range of values expected, when viewed alongside historical results or results obtained for comparable lots of material.

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

[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))

Over-the-Counter (medicines)

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

Any material employed in the packaging of a medicinal product, excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.

Provisional ARTG record

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

See Consumer Medicine Information.

Section 4AA of the Crimes Act 1914 provides a definition of 'penalty unit'

Positron emission tomography

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.

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

The liquid part of uncoagulated blood or lymph, as distinguished from the corpuscles

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

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.

Pre-submission planning form

Pharmaceutical Quality System - updated terminology for QMS, used in the PIC/S Guide to GMP.

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).

(other than where it is a substitute medicine) means a registered therapeutic good included in the ARTG that:

• is a medicine within the meaning of the Act;
• contains a substance mentioned in Schedule 4 or 8 to the Poisons Standard; and
• is normally available for supply in Australia.

Prescription medicines require an authorised health professional's written instruction (prescription) before they can be obtained from a registered pharmacist. The types of therapeutic goods that are regulated as prescription medicines are listed in Part 1 of Schedule 10 of the Therapeutic Goods Regulations 1990.

Action to eliminate the cause of a potential deficiency or nonconformity (based on ISO 9000 Clause 3.12.1). There can be more than one cause for a potential deficiency or nonconformity. Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.

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

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

See Australian Regulatory Guidelines for Medical Devices

In relation to biologicals, means any activity involved in the preparation, manipulation, preservation for storage and packaging of a biological

a type of recall action that raises awareness of concerns about safety, quality, efficacy or performance when discontinuation of treatment is considered riskier than continued use of the deficient product

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'.

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

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

In relation to autologous human cells and tissues products, professional supervision of manufacture means that the medical or dental practitioner with primary responsibility for the clinical care of a patient is party to all manufacturing steps that are performed in a formal governance arrangement with the person or persons undertaking the manufacturing. This would include input into the protocols and quality systems used in the manufacturing process.

A formulation usually containing two or more ingredients for which some information is not in the public domain. Proprietary ingredients include, for example, fragrances, flavours, colouring ingredients, adhesives and printing inks.

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.

Quality Management System - a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organisation.

Quantitative structure activity relationships

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

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.

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

A recall action occurs when there are deficiencies or potential deficiencies in the safety, quality, efficacy, performance or presentation of therapeutic goods. There are four types of recall action:

• recall
• product defect correction
• hazard alert
• product defect alert.

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

Therapeutic goods included in the part of the ARTG for goods known as registered goods; or therapeutic goods included in the part of the ARTG for goods known as provisionally registered goods.

Goods that are required by the Act to be included in that part of the ARTG for Registered goods or for provisionally registered goods.

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.

In relation to eCTD, the term Regulatory Activity is a subgroup of an Application which can be a group of related sequences for one approval or notification process (e.g. one variation). One Regulatory Activity is usually defined for the lifecycle of the specific approval process.

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.

In relation to a medicine that has been the subject of an anticipated or current shortage, means:

• in relation to a medicine which has been the subject of an anticipated shortage - a shortage is no longer anticipated to commence in the future other than by reason that there is a current shortage of the medicine; and
• in relation to a medicine which has been the subject of a current shortage – that the supply of the medicine is now meeting normal consumer demand.

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).

Validation of a process for a product which has been marketed, based upon a review of accumulated manufacturing, testing and batch data.

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

Release for further processing - a release step in the manufacture of medicinal products prior to the final release for supply step.

Risk management plan

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.

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

Self-assessable request

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.

Means the Secretary of the Department of Health

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

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).

In relation to eCTD, a sequence is a package of information bundled together in an electronic structure providing information to the agency. The contents of a sequence will depend on the regulatory activity type and whether it is the initial sequence of the regulatory activity or a follow-up providing additional data or changes.

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

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

In relation to a medicine, means that the supply of the medicine is not reasonably likely to meet the normal or projected consumer demand for the medicine within Australia for a period of time.

Strategic Information Management Environment - now called TGA eBusiness services

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

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).

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.

The outer integument, or covering, of the body — consisting of the dermis and the epidermis and resting upon the subcutaneous tissues

Site Master File

A list of software components used within a medical device, including third-party software, software of unknown provenance (SOUP) and version numbers where applicable.

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

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.

In relation to a medicine, means the person in relation to whom the medicine is included in the ARTG.

In relation to the recall of therapeutic goods, the sponsor also includes the person to whom the goods are on, or cancelled or suspended from the ARTG; or supplying exempt goods; or illegally supplying goods or manufacturing goods.

In relation to a medicinal product, any substance (active or excipient) used in the production of a medicinal product, excluding packaging materials.

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.

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

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

In relation to a medicine which is subject to a shortage, means a medicine that has the same active ingredient as the medicine subject to the shortage, but may have a different strength, dosage form or route of administration.

In general: a person or organisation that is involved in the supply and distribution of the product, but not involved in product manufacture.

In relation to the manufacture of a medicinal product: any entity supplying the starting and/or packaging material to the manufacturer of a medicinal product. This entity should normally be the actual manufacturer of the starting or packaging material, rather than a broker or agent.

The approved entity supplying starting and/or packaging material to the manufacturer of a medicinal product. This entity should normally be the actual manufacturer of the starting or packaging material, rather than a broker or agent. However brokers or agents may be additionally approved if they play significant roles in the supply chain other than merely on-selling the starting or packaging materials.

Includes supply:

1. by way of sale, exchange, gift, lease, loan, hire or hire purchase; and
2. whether free of charge or otherwise, by way of sample or advertisement; and
3. whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons; and
4. by way of administration to, or application in the treatment of, a person.

In relation to a medicine, means the overall arrangements for the meeting of consumer demand.

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

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

The central code of an operating system, managing the core operation of the computer and hardware, most critically computer memory and the central processing unit (CPU).

Tamper-evident packaging

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

Therapeutic Goods Committee

In relation to a medicine which is subject to a shortage, means other therapeutic options that a health professional may consider as an alternative treatment for a patient who may be affected by a shortage of the medicine.

See Therapeutic Goods Advertising Code

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

In relation to cyber security: any circumstance or event with the potential to adversely impact the device, organisational operations (including mission, functions, or reputation), organisational assets, individuals, or other organisations through an information system via unauthorised access, destruction, disclosure, modification of information, and/or denial of service. Threats exercise vulnerabilities, which may impact the safety or essential performance of the device.

Any constituent part of the body formed by cells

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.

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

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

Threshold of toxicological concern

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)

Uniform Recall Procedure for Therapeutic Goods

Universal serial bus

United States Pharmacopoeia

Pertaining to viruses

Validation Master Plan - a document which clearly defines the key elements of a validation program to achieve and maintain a qualified facility and associated systems.

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

Working Cell Bank

World Health Organization