Therapeutic Goods Information (Laboratory Testing) Specification 2017
made under subsection 61(5D) of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 11 November 2023
Includes amendments up to: F2023L01483
About this compilation
This compilation
This is a compilation of the Therapeutic Goods Information (Laboratory Testing) Specification 2017 that shows the text of the law as amended and in force on 11 November 2023 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
1 Name of specification
3 Authority
4 Interpretation
5 Therapeutic goods information
Schedule 1 Specified kinds of therapeutic goods information
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
1 Name of specification
This specification is the Therapeutic Goods Information (Laboratory Testing) Specification 2017.
3 Authority
This specification is made under subsection 61(5D) of the Therapeutic Goods Act 1989.
4 Interpretation
(1) In this specification:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as given in the Therapeutic Goods Regulations 1990.
classification has the same meaning as given in the Therapeutic Goods (Medical Devices) Regulations 2002.
device nomenclature system code has the same meaning as given in Therapeutic Goods (Medical Devices) Regulations 2002.
expiry date has the same meaning as given in the Therapeutic Goods Regulations 1990.
intended purpose has the same meaning as given in Therapeutic Goods (Medical Devices) Regulations 2002.
sample has the same meaning as given in Therapeutic Goods Regulations 1990.
Note: See also subsection (2).
trade name has the same meaning as given in Therapeutic Goods Regulations 1990.
variant has the same meaning as given in Therapeutic Goods (Medical Devices) Regulations 2002.
Note A number of expressions used in this specification are defined in the Act, including the following:
(a) biological number;
(aa) Commonwealth officer;
(b) device number;
(c) included in the Register;
(d) indications;
(e) listing number;
(f) manufacture;
(g) manufacturer;
(h) product information;
(i) quality;
(j) Register;
(k) registration number;
(l) sponsor;
(m) supply;
(n) therapeutic goods; and
(o) therapeutic goods information.
(2) For the avoidance of doubt, a reference in this instrument to a sample includes a sample (or part of a sample) taken, collected or otherwise obtained:
(a) under the Act; or
(b) under regulations made under the Act (including the Therapeutic Goods Regulations 1990); or
(c) by, or at the request or on the instruction of, a Commonwealth officer (including in the exercise of the executive power of the Commonwealth).
(3) For the avoidance of doubt, a reference in this instrument to a test includes a test, analysis or examination conducted or otherwise carried out:
(a) under the Act; or
(b) under regulations made under the Act (including the Therapeutic Goods Regulations 1990); or
(c) by, or at the request or on the instruction of, a Commonwealth officer (including in the exercise of the executive power of the Commonwealth).
5 Therapeutic goods information
The kinds of therapeutic goods information mentioned in Schedule 1 are specified under subsection 61(5D) of the Act for the purposes of subsection 61(5C) of the Act.
Note Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).
Schedule 1 Specified kinds of therapeutic goods information
(section 5)
For each item in column 1 of the following table, the kinds of therapeutic goods information specified in column 2 have the description given in column 3.
Kinds of therapeutic goods information | ||
Column 1 Item | Column 2 Information | Column 3 Description |
1 | description of samples of therapeutic goods | in relation to samples of therapeutic goods included on the Register, the following information, as applicable: (a) trade name, name and quantity of active ingredients, strength, size, dosage form and model of the therapeutic goods; (b) sponsor name; (c) manufacturer name; (d) registration number, listing number, biological number or device number; (e) type, category, class or classification of the therapeutic goods; (f) indications for which the therapeutic goods are included in the Register; (g) batch number, batch code, lot number or serial number of the samples tested; (h) date of manufacture of the samples tested; (i) expiry dates of the samples tested; (j) intended purpose for which the therapeutic goods are included in the Register; (k) description, or functional description, of the therapeutic goods included in the Register; (l) device nomenclature system code, term and definition of the therapeutic goods; (m) unique product identifier given to the therapeutic goods by the manufacturer to identify the goods and any variants of those goods; (n) names of ingredients or components used in the manufacture of the therapeutic goods; (o) information relating to any sterilisation method used in relation to the therapeutic goods;
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| (p) information relating to the software and firmware necessary for the proper application of the therapeutic goods, including the relevant version; and (q) information relating to the supply and manufacture of therapeutic goods relevant to the testing including, but not limited to, product information, consumer medicines information, directions for use, instructions for use, operational manuals, advertising material, and packaging information; and |
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| in relation to samples of therapeutic goods that are not included in the Register, the following information, as applicable: (a) a description of the physical appearance of the therapeutic goods, including the name, dosage form or model, and any other identifying features or characteristics such as colour, shape, labelling and packaging; (b) names of ingredients or components used, or purported to have been used, in the manufacture of the therapeutic goods; and (c) information relating to the supply and manufacture of the therapeutic goods relevant to the testing including, but not limited to, directions for use, instructions for use, operational manuals, and advertising material |
2 | test reason | the reason for testing the therapeutic goods |
3 | test description | the name and description of the tests performed, including information relating to the scope of the tests and any applicable standards relevant to the testing |
4 | test date | the date or date ranges in which the testing was performed on the samples |
5 | test results | a summary of test results and compliance with relevant aspects of the labelling requirements applicable to the therapeutic goods under the Act, including whether or not the samples passed or failed and, in relation to the samples that failed, general information about the aspect of testing that those samples failed against |
6 | test outcome | a summary of the outcome of the testing, and any other subsequent action or investigation undertaken, including action undertaken by the Secretary, sponsor or manufacturer in response to the test results |
7 | related quality, safety and efficacy information | quality, safety and efficacy information, including information about the supply or manufacture of therapeutic goods or the class of therapeutic goods, that is relevant to the test reason, the test results or the test outcome for the samples of the therapeutic goods |
Note
1. All legislative instruments and compilations are registered on the Federal Register of Legislation kept under the Legislation Act 2003. See http://www.legislation.gov.au
Endnotes
Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.
If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.
Endnote 2—Abbreviation key
ad = added or inserted | orig = original |
am = amended | par = paragraph(s)/subparagraph(s) |
amdt = amendment | /sub‑subparagraph(s) |
c = clause(s) | pres = present |
C[x] = Compilation No. x | prev = previous |
Ch = Chapter(s) | (prev…) = previously |
def = definition(s) | Pt = Part(s) |
Dict = Dictionary | r = regulation(s)/rule(s) |
disallowed = disallowed by Parliament | reloc = relocated |
Div = Division(s) | renum = renumbered |
exp = expires/expired or ceases/ceased to have | rep = repealed |
effect | rs = repealed and substituted |
F = Federal Register of Legislation | s = section(s)/subsection(s) |
gaz = gazette | Sch = Schedule(s) |
LA = Legislation Act 2003 | Sdiv = Subdivision(s) |
LIA = Legislative Instruments Act 2003 | SLI = Select Legislative Instrument |
(md not incorp) = misdescribed amendment | SR = Statutory Rules |
cannot be given effect | Sub‑Ch = Sub‑Chapter(s) |
mod = modified/modification | SubPt = Subpart(s) |
No. = Number(s) | underlining = whole or part not |
o = order(s) | commenced or to be commenced |
Ord = Ordinance |
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Endnote 3—Legislation history
Name | Registration | Commencement | Application, saving and transitional provisions |
Therapeutic Goods Information (Laboratory Testing) Specification 2017 | 10 Apr 2017 (F2017L00407) | 11 Apr 2017 | — |
Therapeutic Goods Information (Laboratory Testing) Amendment Instrument 2023 | 10 Nov 2023 (F2023L01483) | 11 Nov 2023 | — |
Endnote 4—Amendment history
Provision affected | How affected |
s 2………………………………. | rep LA s 48D |
s 4………………………………. | am F2023L01483 |