Cosmetic Compliance
Intelligence & Solutions
Therapeutic Goods Act 1989
Local Title:
/
Country/Region:
Australia
Competent Authority:
Therapeutic Goods Administration
Type:
Regulation
Status:
In force
Release Date:
2019-01-01
Implementation Date:
2019-01-01
Document
Language Source Title Access
EN
Official therapeutic_goods_act_1989.pdf
Summary

Therapeutic Goods Act 1989 sets out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, including advertising, labelling and product appearance. The legislation also sets out the rights of individuals to have a decision that affects them, reviewed.

Therapeutic Goods Act 1989 is designed to provide for the establishment and maintenance of a national system of controls relating to the quality, safety, timely availability and, where necessary, efficacy, of therapeutic goods that are:

  • used in Australia, whether produced in Australia or elsewhere; or
  • exported from Australia; and
  • to provide a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia.

Chapter 1—Preliminary

Chapter 2—Australian Register of Therapeutic Goods

Chapter 3—Medicines and other therapeutic goods that are not medical devices

Chapter 4—Medical devices

Chapter 5—Advertising, counterfeit therapeutic goods and product tampering

Chapter 5A—Enforcement

Chapter 6—Administration

Chapter 7—Miscellaneous

Chapter 8—Repeal and transitional provisions

Noteworthy Information