Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01466 In force Legislative Instrument

Legislation content

 

 

Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021

made under subsection 23B(10) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date: 1 April 2025

Includes amendments: F2025L00328

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021 that shows the text of the law as amended and in force on 1 April 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. 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

3  Authority

4  Definitions

5  Application

6  Form of information

7  Application, savings and transitional provisions

Schedule 1—Prescription 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 (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021.

3  Authority

  This instrument is made under subsection 23B(10) 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) medicine;

(c) Register;

(d) registered goods.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

biosimilar means a medicine that is a biosimilar in relation to a registered medicine.

eCTD means the electronic Common Technical Document standard format, including:

 (a) Module 1 in accordance with eCTD AU module 1 and regional information v3.2, as in force or existing on 1 April 2025; and

 (b) Modules 2 to 5 in accordance with ICH eCTD Specification v3.2.2, as in force or existing on 1 April 2025.

Note: The eCTD AU module 1 and regulation information v3.2 is published by the TGA on the TGA website at www.tga.gov.au. The ICH eCTD Specification v3.2.2. is published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and is available at www.ich.org.

extension of indications medicine means a medicine that:

 (a) contains the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine included in the Register; and

 (b) has one or more indications in addition to that other medicine.

generic product has the same meaning as in the Regulations.

major variation has the same meaning as in clause 1 of Schedule 9 to the Regulations.

major variation medicine means a medicine that is taken to be separate and distinct from a registered medicine because of a major variation but does not include:

 (a) a new chemical entity medicine; or

 (b) a new biological entity medicine; or

 (c) a new biosimilar medicine; or

 (d) a new combination medicine; or

 (e) an extension of indications medicine; or

 (f) a new generic medicine; or

 (g) a new trade name medicine.

new biological entity medicine means a medicine that:

 (a) has not previously been included in the Register, and contains a biological substance; or

 (b) contains a biological substance mentioned in paragraph (c) of the definition of new chemical entity.

new biosimilar medicine means a medicine that has not previously been included in the Register and is a biosimilar in relation to a registered medicine.

new chemical entity has the same meaning as in clause 1 of Part 1 of Schedule 9 to the Regulations.

new chemical entity medicine means a medicine that contains a new chemical entity as mentioned in paragraphs (a), (b) and (d) of the definition of new chemical entity.

new combination medicine means a medicine that contains a new chemical entity as mentioned in paragraph (e) of the definition of new chemical entity.

new generic medicine means a medicine that has not previously been included in the Register and is a generic product.

new trade name medicine means a medicine that:

 (a) has the same active ingredient or active ingredients (or fixed combination of active ingredients) as a registered medicine; and

 (b) has the same indications as that other medicine; and

 (c) has the same dosage form as that other medicine; and

 (d) has been given a different name to that other medicine by the manufacturer, under which the medicine will be supplied.

registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.

Regulations means the Therapeutic Goods Regulations 1990.

Therapeutic Goods Administration has the same meaning as in the Regulations.

5  Application

  This instrument applies to medicines of the class specified in paragraph 4(1)(a) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.

Note: The Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018 is a notifiable instrument and is published on the Federal Register of Legislation at www.legislation.gov.au.

6  Form of information

  For the purposes of subparagraph 23B(2)(d)(ii) of the Act, the information in an application dossier, that accompanies an application for the registration of a medicine mentioned in Schedule 1, must be in:

 (a) the eCTD format; or

 (b) if exceptional circumstances exist—another format with the prior written agreement of the Therapeutic Goods Administration.

7  Application, savings and transitional provisions

  This instrument, as in force immediately before the amendments made by the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Amendment Determination 2025, continues to apply to applications for registration made before 1 October 2025.


Schedule 1—Prescription Medicines

Note: See section 6.

 

Prescription medicines

Column 1

Column 2

Item

Prescription medicines

1

new chemical entity medicine

2

new biological entity medicine

3

new biosimilar medicine

4

new combination medicine

5

extension of indications medicine

6

major variation medicine

7

new generic medicine

 

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

 

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021

28 Oct 2021

(F2021L01466)

s 1-7 and Sch 1 (items 1-4): 1 Nov 2021 (s 2(1) items 1, 2)

Sch 1 (items 5-7): 1 June 2022 (s 2(1) item 3)

—

Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Amendment Determination 2025

11 Mar 2025

(F2025L00328)

1 Apr 2025

—

 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2………………………………..

rep LA s 48D

s 4………………………………..

am F2025L00328

s 7………………………………..

ad F2025L00328

 

Overview

The Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021 was enacted to standardise the information requirements for applications for the registration of prescription medicines in Australia. It was made under subsection 23B(10) of the Therapeutic Goods Act 1989 by the Therapeutic Goods Administration, which is responsible for regulating therapeutic goods in Australia. The policy objective of this determination is to ensure that all necessary information is provided in a consistent and efficient manner to facilitate the review and registration of prescription medicines. This legislation applies to various types of prescription medicines, including new chemical entity medicines, new biological entity medicines, and others, and mandates that the information accompanying applications for their registration must be submitted in either the eCTD format or, under exceptional circumstances, another format agreed upon with the Therapeutic Goods Administration. The determination also includes provisions for transitional arrangements to ensure continuity in the application of the requirements during periods of amendment.

Scope and Application

The Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021 applies to applications for the registration of prescription medicines within the classes specified in the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018. The classes covered by this determination include new chemical entity medicines, new biological entity medicines, new biosimilar medicines, new combination medicines, extension of indications medicines, major variation medicines, and new generic medicines. The determination applies nationally and is made under the Therapeutic Goods Act 1989. It mandates that the information accompanying an application for the registration of these prescription medicines must be submitted in either the electronic Common Technical Document (eCTD) format or, under exceptional circumstances, in another format agreed upon in writing by the Therapeutic Goods Administration. The determination initially applied to certain classes of medicines from 1 November 2021, with additional classes subject to the requirements from 1 June 2022. The determination continues to apply to applications made before 1 October 2025, as per the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Amendment Determination 2025.

Key Provisions

The Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021, under subsection 23B(10) of the Therapeutic Goods Act 1989, sets forth the requirements for information accompanying applications for the registration of certain prescription medicines. The primary focus of the Determination is to mandate the format in which such information must be presented. Specifically, Section 6 requires that the information accompanying an application for the registration of a medicine listed in Schedule 1 must be submitted in either the eCTD format or, if exceptional circumstances apply, in another format agreed upon in writing by the Therapeutic Goods Administration. Entities governed by this Determination, primarily those submitting applications for the registration of prescription medicines, must ensure that their application dossiers comply with the specified format requirements. This means that the information provided must be structured according to the eCTD standard, which includes detailed specifications for Modules 1 through 5, unless an alternative format has been expressly approved by the Therapeutic Goods Administration. Failure to comply with the requirements of this Determination can result in significant consequences. Although the Determination itself does not explicitly outline penalties for non-compliance, the Therapeutic Goods Act 1989 provides for various civil and criminal penalties. For instance, under Section 34 of the Act, failure to comply with certain provisions can result in substantial fines, imprisonment, or both. Additionally, the Act allows for the refusal of registration applications that do not meet the necessary standards, which can severely impact the availability of the medicine in the market. The Determination also includes transitional provisions, as outlined in Section 7, which allow the previous version of the Determination to continue to apply to applications for registration made before 1 October 2025. This ensures a smooth transition for entities that may have been in the process of submitting applications before the amendments took effect.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.