Commonwealth legislation

Therapeutic Goods (Listing) Notice 2005 (No. 6)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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

What this does: This notice temporarily allows specific toothpastes and tooth-cleaning products containing sodium monofluorophosphate (a fluoride compound) to be sold in Australia under the "listed" medicines pathway—a less stringent regulatory route than full registration.

Who it affects: Manufacturers and importers of fluoride toothpastes that combine this ingredient with other approved active ingredients.

The rules:

Fluoride concentration must not exceed 1000 mg/kg
Products must be pastes, powders, or gels used only for cleaning teeth
Labels can only claim the product improves oral hygiene or prevents tooth decay—no other health claims are permitted

Why it matters: Ingredients usually need to be specifically named in the Regulations to qualify for this pathway. This notice acts as a temporary bridge, allowing these products onto the market until the Regulations are formally updated to include sodium monofluorophosphate permanently.

JSON API Health / NDIS / medicines

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Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2005 (No. 6).

Therapeutic Goods (Listing) Notice 2005 (No. 6)

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Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2005 (No. 6)

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 (Item 3) of the Therapeutic Goods Regulations 1990 (the Regulations), that contain, in combination with at least one other therapeutically active ingredient referred to in Item 3, sodium monofluorophosphate, being a substance that is to be mentioned in Part 3 of Schedule 4 of the Regulations, and which comply with the following requirements:

- the concentration of fluoride is not more than 1000 mg/kg; and

- the substance is for use only in pastes, powders or gels for the cleaning of teeth; and

- claims in relation to fluoride content are restricted to those relating to improvements in oral hygiene or the use of fluoride for the prevention of tooth decay.

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 substance listed in this Notice in the part of the ARTG for listed goods.

Dated this 28th day of October 2005

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 2005 (No. 6)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2005 (No. 6)

preparations, referred to in Item 3, Part 1 of Schedule 4 (Item 3) of the Therapeutic Goods Regulations 1990 (the Regulations), that contain, in combination with at least one other therapeutically active ingredient referred to in Item 3, sodium monofluorophosphate, being a substance that is to be mentioned in Part 3 of Schedule 4 of the Regulations, and which comply with the following requirements:

- the concentration of fluoride is not more than 1000 mg/kg; and

- the substance is for use only in pastes, powders or gels for the cleaning of teeth; and

- claims in relation to fluoride content are restricted to those relating to improvements in oral hygiene or the use of fluoride for the prevention of tooth decay.

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

Dated this 28th day of October 2005

Dr David Graham

Delegate of the Minister for Health and Ageing