Therapeutic Goods (Listing) Notice 2008 (No. 1)

Federal Register of Legislative Instruments (FRLI): Legislative Instrument - F2008L00384 (14 February 2008)

Therapeutic Goods Act 1989

I, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, and the 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, in combination with at least one other therapeutically active ingredient referred to in Item 3, sodium fluoride, being a substance that is to be mentioned in Part 3 of Schedule 4 of the Therapeutic Goods Regulations 1990, and which comply with the following requirements:
  • the concentration of fluoride is not more than 1,000 mg/kg; and
  • the substance is for use only in pastes, powders or gels for dental hygiene; and
  • claims in relation to fluoride content are restricted to those relating to improvements in dental 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 Therapeutic Goods Regulations 1990 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 4th day of February 2008

Dr Rohan Hammett
Delegate of the Minister for Health and Ageing