Therapeutic Goods (Listing) Notice 2015 (No. 2) (Cth)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2015 (No. 2)

I, JOHN SKERRITT, National Manager of the Therapeutic Goods Administration, delegate of the Minister for Health for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) and acting under that provision HEREBY:

1. REVOKE the following legislative instruments made under section 9A(5) of the Act:

   (a)Therapeutic Goods (Listing) Notice 2005 (No.5);

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

   (c)Therapeutic Goods (Listing) Notice 2006 (No. 1);

   (d)Therapeutic Goods (Listing) Notice 2006 (No. 2); and

   (e)Therapeutic Goods (Listing) Notice 2006 (No. 3); and

1. REQUIRE the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods for listed goods:

   (a)preparations that contain, as their therapeutically active ingredient, any one of the following substances:

   (i)     citric acid anhydrous;

   (ii)   citric acid monohydrate;

   (b)preparations that contain, as their therapeutically active ingredient, in combination with at least one other therapeutically active ingredient referred to in Item 3 of Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990, the substance “sodium monofluorophosphate”, and which comply with the following requirements:

   (i)   the concentration of fluoride is not more than 1000 mg/kg; and

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

   (iii)   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;

   (c)preparations, for oral use, that contain as their therapeutically active ingredient, whole dried Undaria pinnatifida, excluding the holdfast;

   (d)preparations, for oral and topical use, that contain, as their therapeutically active ingredient, conifer green needle complex, that are made by petroleum ether extraction of needles of the following conifer species:

   (i)     Pinus sylvestris (Scotch pine); and

   (ii)   Picea abies (Norwegian Spruce);

   (e)Preparations, for oral use, that contain as their therapeutically active ingredient, Trametes versicolor proteoglycan concentrate.

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

Dated this 22^nd day of June 2015

(Signed by)

JOHN SKERRITT
Delegate of the Minister for Health