Federal Register of Legislation - Australian Government

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Notices & Notifications as made
The Listing Notice permits the use of sodium monofluorophosphate (SMFP), under certain conditions, as an active ingredient in low risk (Listed) complementary medicines.
Administered by: Health
General Comments: Pursuant to subsection 9A(6) of the Therapeutic Goods Act 1989, 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.
Made 28 Oct 2005
Registered 08 Nov 2005
Tabled HR 10 Nov 2005
Tabled Senate 10 Nov 2005
Date of repeal 09 Jul 2015
Repealed by Therapeutic Goods (Listing) Notice 2015 (No. 2)

 

 

Therapeutic Goods Act 1989

 

 

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:

 

ยท          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