Commonwealth legislation

Therapeutic Goods (Listing) Notice 2009 (No. 8)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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

2/10 complexity

This notice temporarily approves a specific brand of Welsh mineral water to be sold in Australia as an iron supplement.

What it does

Allows products containing "Trefriw Wells mineral water" (sourced exclusively from Trefriw Wells Spa in North Wales, UK) to be listed on the Australian Register of Therapeutic Goods (ARTG)
Only applies when the mineral water is packaged in single-use sachets and marketed for oral use as an iron supplement

Who it affects

Companies importing or manufacturing iron supplements using this specific Welsh mineral water
Consumers seeking natural mineral-based iron supplements

Why it matters Therapeutic goods usually cannot be sold in Australia until formally approved in the regulations. This notice creates a temporary legal exemption for this particular mineral water, permitting sale while formal regulatory amendments are prepared. The permission automatically ends once those permanent regulation changes take effect.

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Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2009 (No. 8).

Therapeutic Goods (Listing) Notice 2009 (No. 8)

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Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2009 (No. 8)

I, CHARLES MASKELL-KNIGHT, Acting 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 (‘the ARTG’) for listed goods:

preparations for the purposes of Schedule 4 of the Therapeutic Goods Regulations 1990 (‘the Regulations’) for oral use that contain “Trefriw Wells mineral water” as a therapeutically active ingredient when presented in single use sachets for therapeutic use as an iron supplement.

For the purposes of this Notice, Trefriw Wells mineral water means a naturally-occurring mineral water that is sourced from Trefriw Wells Spa, North Wales, United Kingdom.

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 Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods.

Dated this 13th day of November 2009

(signed by)

Charles Maskell-Knight

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 2009 (No. 8)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2009 (No. 8)

preparations for the purposes of Schedule 4 of the Therapeutic Goods Regulations 1990 (‘the Regulations’) for oral use that contain “Trefriw Wells mineral water” as a therapeutically active ingredient when presented in single use sachets for therapeutic use as an iron supplement.

For the purposes of this Notice, Trefriw Wells mineral water means a naturally-occurring mineral water that is sourced from Trefriw Wells Spa, North Wales, United Kingdom.

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

Dated this 13th day of November 2009

(signed by)

Charles Maskell-Knight

Delegate of the Minister for Health and Ageing