Commonwealth legislation

Therapeutic Goods (Listing) Notice 2007 (No. 1)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

3/10 complexity

This notice allows specific fish oil supplements to be sold in Australia as "listed" therapeutic goods (a lower-risk category of medicines that don't require individual pre-approval).

What it does

Adds oral preparations containing Fish Oil Rich in Omega-3-Acids (meeting British Pharmacopoeia 2005 standards) to the Australian Register of Therapeutic Goods (ARTG)
This registration is required before these products can be legally supplied in Australia

Who it affects

Manufacturers and importers of omega-3 fish oil supplements
Consumers buying these products (ensures they meet specific quality standards)

Important note This is a temporary measure. The notice automatically expires once the Therapeutic Goods Regulations are formally updated to permanently include this substance in the register for listed goods.

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Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2007 (No. 1).

Therapeutic Goods (Listing) Notice 2007 (No. 1)

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Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2007 (No. 1)

I, DAVID GRAHAM, National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (ARTG) for listed goods:

preparations, referred to in Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990, for oral use that contain, as their therapeutically active ingredient, Fish Oil Rich in Omega-3-Acids, as described in the British Pharmacopoeia 2005, being a substance that is to be mentioned in Division 1 of Part 5 of Schedule 4 of the Therapeutic Goods Regulations 1990.

This Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.

Pursuant to subsection 9A(6) of the Act this Notice ceases to have effect on the day that amendments to the Therapeutic Goods Regulations 1990 come into effect to require inclusion of the substance listed in this Notice in the part of the ARTG for Listed goods.

Dated this eighth day of March 2007

Dr David Graham

Delegate of the Minister for Health and Ageing

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Therapeutic Goods (Listing) Notice 2007 (No. 1)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2007 (No. 1)

preparations, referred to in Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990, for oral use that contain, as their therapeutically active ingredient, Fish Oil Rich in Omega-3-Acids, as described in the British Pharmacopoeia 2005, being a substance that is to be mentioned in Division 1 of Part 5 of Schedule 4 of the Therapeutic Goods Regulations 1990.

This Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.

Dated this eighth day of March 2007

Dr David Graham

Delegate of the Minister for Health and Ageing