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Therapeutic goods orders

If you intend to rely on any legislation referred to on this website, you should access copies of the official versions on the Attorney-General's ComLaw website, which incorporates the Federal Register of Legislative Instruments (FRLI). Instruments are amended from time to time and may, on occasions, be replaced or new instruments made.

Therapeutic goods must comply with various standards, which determine the consistency of product quality, including label quality. Many of these standards are international standards. However, sometimes it is necessary to specify an Australian standard, either for a particular type of therapeutic good or to specify particular labelling, packaging or other requirements. In these situations a Therapeutic Goods Order (TGO) is published.

Since 1992, TGOs have been approved by a delegate of the Minister under section 10 of the Therapeutic Goods Act 1989 after consultation with the Therapeutic Goods Committee. Prior to this the TGOs were approved under various sections of the Therapeutic Goods Act 1966.

Current TGOs

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Recently spent/repealed instruments

The following instruments were repealed by the Health (Spent and Redundant Instruments) Repeal Regulation 2014 ('the Regulation').

The instruments repealed by the Regulation fall into two groups, explained below.

1. Instruments that were amending or revoking instruments and were spent (Schedule 1 of the Regulation)

These instruments amended or revoked principal TGOs and were therefore "spent". The amendments effected by these instruments have been incorporated into subsequent consolidations of their corresponding principal instrument (with the exception of TGO 67, which has itself been repealed - see section 2 below).

The amending instruments are therefore no longer needed. These instruments are as follows:

2. Instruments that were no longer required (Part 3 of Schedule 4 of the Regulation)

The instruments in this group were redundant and no longer required.

At its 39th meeting the Therapeutic Goods Committee provided advice on the revocation of the following standards.

These orders (predominantly relating to medical devices) were made before the introduction of Chapter 4 to the Therapeutic Goods Act 1989, which set out a specific regulatory regime for medical devices and provided for a transition period for existing medical devices that were then regulated under Chapter 3 of the Act. As that transition period ended in 2007, the repeal of the orders does not alter existing arrangements.

These instruments are as follows:

TGO guidance

Web page last updated: Tuesday, 19 August 2014

URL: http://www.tga.gov.au/industry/legislation-tgo.htm