Document ID: chunk:federal_register_of_legislation:F2025C00036:front:0:p1
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Therapeutic Goods Regulations 1990

Statutory Rules No. 394, 1990
made under the

Therapeutic Goods Act 1989

Compilation No. 124

Compilation date: 1 January 2025

                Includes amendments: F2024L00689

About this compilation

This compilation

This is a compilation of the Therapeutic Goods Regulations 1990 that shows the text of the law as amended and in force on 1 January 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.

Editorial changes

For more information about any editorial changes made in this compilation, see 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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
Part 1—Preliminary
1 Name of Regulations
2 Interpretation
2A Authorised officers
3 Corresponding State law
3AA Unacceptable presentation of therapeutic goods—prescribed class of medicine
3A Unacceptable presentations
3B Definitions relating to goods comprising etc. human cells and tissues
3C Classes of biologicals
Part 2—Advertisements
Division 1—Application of Part
4 Application of Part 2
4A Interpretation
Division 3—General provisions about advertising therapeutic goods
6AA Prescribed committees
6B Prohibited and required representations
7 Prescribed goods for advertising offence and civil penalty
7A Publisher exception for civil penalty provisions
Division 4—Generic information about ingredients or components of therapeutic goods
8 Compliance with the Code
Part 2A—Patient information
9A Information about certain therapeutic goods to be supplied
9B Information about therapeutic goods manufactured using human embryos
Part 2C—Australian Register of Therapeutic Goods
Division 2C.1—Registered and listed therapeutic goods
10 Goods to be included in parts of the Register (Act s 9A)
10AAA Variation of entries in Register—registered complementary medicines and registered OTC medicines
10AAB Variation of