Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023
made under subsection 61(5D) of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 23 December 2025
Includes amendments: F2025L01620
About this compilation
This compilation
This is a compilation of the Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023 that shows the text of the law as amended and in force on 23 December 2025 (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. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).
Application, saving and transitional provisions
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. Any modifications affecting the law are accessible on the Register.
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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
3 Authority
4 Definitions
5 Release of therapeutic goods information
Schedule 1—Therapeutic goods information
Part 1—DAEN – Medical Devices
Part 2—DAEN – Medicines
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
1 Name
This instrument is the Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023.
3 Authority
This instrument is made under section 61(5D) of the Therapeutic Goods Act 1989.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) biological;
(b) manufacturer;
(c) medical device;
(d) medicine;
(e) Register;
(f) Secretary;
(g) sponsor;
(h) therapeutic goods.
In this instrument:
Act means the Therapeutic Goods Act 1989.
adverse event means the following:
(a) in relation to a medicine or biological—an adverse event that occurs in relation to a person in Australia following the administration of a medicine or a biological;
(b) in relation to a medical device or other therapeutic good—an adverse event that occurs in relation to a person in Australia following use of a medical device or other therapeutic good that led, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, that person.
Note: An adverse event may not necessarily have a causal relationship with the administration or use of the therapeutic good.
DAEN – Medical Devices means the Database of Adverse Event Notifications for medical devices and other therapeutic goods, maintained by the Therapeutic Goods Administration.
DAEN – Medicines means the Database of Adverse Event Notifications for medicines and biologicals, maintained by the Therapeutic Goods Administration.
defect, in relation to a medical device or other therapeutic good, means any of the following that might lead, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, a person:
(a) any malfunction or deterioration in the characteristics or performance of the medical device or other therapeutic good;
(b) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the medical device or other therapeutic good.
event outcome, in relation to a medical device or other therapeutic good, means one of the following outcomes reported to the TGA in relation to an adverse event:
(a) death;
(b) injury;
(c) no injury;
(d) unknown.
event type, in relation to a medical device or other therapeutic good, means the event type described in the IMDRF Terminology Document that is applicable to the adverse event.
IMDRF Terminology Document means the Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes, published by the International Medical Device Regulators Forum, as in force or existing from time to time.
MedDRA means the Medical Dictionary for Regulatory Activities published by the MedDRA Maintenance and Support Services Organization, as in force or existing from time to time.
other therapeutic good means a therapeutic good that is not a medicine, biological or medical device.
report source category, in relation to a medical device or other therapeutic good, means one of the following categories describing the person who reported the adverse event:
(a) consumer;
(b) health professional;
(c) industry;
(d) government;
(e) other.
Therapeutic Goods Administration, or TGA, means the part of the Department known as the Therapeutic Goods Administration.
therapeutic goods information has the meaning given by subsection 61(1) of the Act.
5 Release of therapeutic goods information
The kinds of therapeutic goods information set out in the tables in Parts 1 and 2 of Schedule 1 are specified for the purpose 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—Therapeutic goods information
Note: See section 5.
Part 1—DAEN – Medical Devices
Column 1 | Column 2 |
Item | Kinds of therapeutic goods information |
1 | information about an adverse event or defect in relation to a medical device or other therapeutic good, that has been reported to the TGA and is recorded in the DAEN – Medical Devices (medical device adverse event report), as follows: (a) details of the medical device or other therapeutic good; (b) details of the manufacturer of the medical device or other therapeutic good; (c) details of the sponsor of the medical device or other therapeutic good; (d) details of any other therapeutic good reported to have been involved in the adverse event; (e) the description of the adverse event; (f) the event outcome; (g) the event type; (h) the report source category; (i) the date that the medical device adverse event report was received by the TGA; (j) the unique number allocated to the medical device adverse event report by the TGA |
Part 2—DAEN – Medicines
Column 1 | Column 2 |
Item | Kinds of therapeutic goods information |
1 | information about an adverse event in relation to a medicine or biological that has been reported to the TGA and is recorded in the DAEN – Medicines (medicine adverse event report), as follows: (a) details of the medicine or biological; (b) details of any other therapeutic good administered to the person who is reported to have suffered the adverse event (the relevant person); (c) the age of the relevant person; (d) the sex of the relevant person; (e) the adverse event description term, as described in the MedDRA, that relates to the adverse event; (f) the date that the adverse event was recorded by the TGA; (g) the unique number allocated to the adverse event report by the TGA |
2 | information collated by the TGA from reports of adverse events received by the TGA in relation to a medicine or biological and recorded in the DAEN – Medicines (relevant cases), as follows: (a) the number of relevant cases; (b) the number of relevant cases where death was a reported outcome; (c) the number of relevant cases in which the medicine or biological was reported to be the only therapeutic good suspected of being related to the adverse event; (d) the system organ class terminology, as described in the MedDRA, for the part of the body that was reported as being affected by each adverse event; (e) the adverse event description term, as described in the MedDRA, that relates to each adverse event |
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 | p = page(s) |
amdt = amendment | para = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub‑subparagraph(s) |
ch = Chapter(s) | pres = present |
cl = clause(s) | prev = previous |
cont. = continued | (prev…) = previously |
def = definition(s) | pt = Part(s) |
Dict = Dictionary | r = regulation(s)/Court 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 |
gaz = gazette | s = section(s)/subsection(s) |
LA = Legislation Act 2003 | /rule(s)/subrule(s)/order(s)/suborder(s) |
LIA = Legislative Instruments Act 2003 | sch = Schedule(s) |
(md not incorp) = misdescribed amendment | SLI = Select Legislative Instrument |
cannot be given effect | SR = Statutory Rules |
mod = modified/modification | sub ch = Sub‑Chapter(s) |
No. = Number(s) | sub div = Subdivision(s) |
Ord = Ordinance | sub pt = Subpart(s) |
| underlining = whole or part not |
| commenced or to be commenced |
Endnote 3—Legislation history
Name | Registration | Commencement | Application, saving and transitional provisions |
Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Instrument 2023 | 26 Sep 2023 (F2023L01291) | 30 Sep 2023 | — |
Therapeutic Goods (Information Specification—Database of Adverse Event Notifications) Amendment Instrument 2025 | 22 Dec 2025 (F2025L01620) | 23 Dec 2025 | — |
Endnote 4—Amendment history
Provision affected | How affected |
s 2……………………………….… | rep LA s 48D |
s 6……………………………….… | rep LA s 48C |
Schedule 1………………………… | am F2025L01620 |
Schedule 2………………………… | rep LA s 48C |