Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2015 (No. 4)

I, Trisha Garrett, First Assistant Secretary, Medicines Regulation of the Regulatory Services Group, delegate of the Minister for Health for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods:

• preparations that contain ‘ribose’ as a therapeutically active ingredient, subject to the following conditions:
  • the preparations are for oral use only; and
  • the containers, and any other packaging, for the preparations are labelled with the following advisory statement:

  “contains ribose which is a sugar”.

• preparations that contain ‘calcium pyruvate’ or ‘magnesium pyruvate’ as a therapeutically active ingredient, subject to the following conditions:
  • the preparations are for oral use only; and
  • the recommended daily intake is less than 7 g; and
  • a statement is included on the label, indicating the equivalent of calcium or magnesium if intended use of the ingredient is as a mineral supplement.
• preparations that contain ‘octanoic acid’ as a therapeutically active ingredient, subject to the following conditions:
  • the preparations are for oral or topical use only; and
  • the topical formulations do not exceed 2% (w/w) octanoic acid.
• preparations that contain ‘Terminalia arjuna’ as a therapeutically active ingredient, subject to the following conditions:
  • the ingredient consists of the bark of Terminalia arjuna only;
  • the preparations are for oral use only;
  • the preparations provide a daily dose of not more than 6 g of Terminalia arjuna dried bark (or its extract equivalent); and
  • the preparations do not contain any directions for use in children or pregnant or lactating women.
• preparations that contain ‘Berberis aristata’ as a therapeutically active ingredient, subject to the following conditions:
  • the preparations are for oral use only; and
  • the preparations do not contain any directions for use in pregnant or lactating women.

• preparations that contain ‘co-methylcobalamin’ as a therapeutically active ingredient, subject to the following condition:
  • the preparations are for oral use only.
• preparations that contain ‘choline dihydrogen citrate’ as a therapeutically active ingredient, subject to the following condition:
  • the preparations are for oral use only.
• preparations that contain ‘Lepidium meyenii’ as a therapeutically active ingredient, subject to the following conditions:
  • the ingredient consists of the dried tuber of Lepidium meyenii only;
  • the preparations are for oral use only; and
  • the preparations provide a daily dose of not more than 3.5 g of Lepidium meyenii dried tuber (or its extract equivalent).
• preparations that contain ‘Trachyspermum ammi’ as a therapeutically active ingredient, subject to the following conditions:
  • the ingredient consists of the fruit and/or seed of Trachyspermum ammi only;
  • the preparations are for oral use only; and
  • the preparations do not contain any directions for use by persons intending to become pregnant or in pregnant or lactating women.
• preparations that contain ‘dimethylglycine hydrochloride’ as a therapeutically active ingredient, subject to the following condition:
  • the preparations are for oral use only.

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

Dated this 7 day of September 2015

(Signed by)

Trisha Garrett

Delegate of the Minister for Health