Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p1
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 0–3926

Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
made under section 10 of the

Therapeutic Goods Act 1989

                      Compilation No. 4

                      Compilation date: 7 December 2024

                      Includes amendments: F2024L01591
About this compilation

This compilation

This is a compilation of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines that shows the text of the law as amended and in force on 7 December 2024 (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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
Introduction.........................................................1
1 Name of Order..................................................3
3 Application - Therapeutic goods to which this Order applies...........3
4 Transition arrangements..........................................3
5 Exemptions – Medicines to which this Order does not apply...........4
6 Interpretation....................................................5
7 General requirements, including label presentation..................12
8 Information to be included on the label............................13
9 Information to be included on the main label........................16
10 Qualifications and special requirements.........................19
11 How information is to be expressed.............................31
12 Application, savings and transitional provisions...................38
Schedule 1........................................................39
Substances or Groups of substances present in medicines that are required to be declared on the label of medicines......39
Schedule 2........................................................44
Specified ingredient names..........................................44
Part 1—Dual labelling name permitted from 1 May 2023 until 30 April 2026.44
Part 2—Dual labelling name permitted from 1 May 2025 until 30 April 2028.44
Part 3—Dual labelling name.........................................45
Schedule 3........................................................46
Specified neuromuscular blocking agents (or salts thereof)...............46
Endnotes..............................................................48
Endnote 1—About the endnotes........................................48
Endnote 2—Abbreviation key..........................................49
Endnote 3—Legislation history.........................................50
Endnote 4—Amendment history........................................51

     Introduction

      1.            This Order sets out what kinds of