Commonwealth legislation

Therapeutic Goods (Listing) Notice 2014 (No. 3)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

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Commonwealth

Collection

legislative instrument

Plain English Summary

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This notice temporarily requires low‑dose oral iron supplements to be listed on the Australian Register of Therapeutic Goods (ARTG), ensuring they meet safety and quality oversight. It affects manufacturers and suppliers of these products in Australia and remains in force only until the Therapeutic Goods Regulations are amended to make the requirement permanent.

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Therapeutic Goods (Listing) Notice 2014 (No. 3)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2014 (No. 3)

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, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods:

preparations, for the purpose of Item 3 of Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘iron’ (also known as elemental iron) as a therapeutically active ingredient, subject to the following conditions:

the preparations contain a daily dose of not more than 24 mg of iron; and
the primary pack contains not more than 750 mg of iron if the divided preparations contain more than 5 mg of iron per dosage unit; and
the preparations are for oral use only.

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 therapeutic goods listed in this Notice in the part of the Register for listed goods.

Dated this 24th day of June 2014

(Signed by)

Professor John Skerritt

Delegate of the Minister for Health

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Therapeutic Goods (Listing) Notice 2014 (No. 3)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2014 (No. 3)

preparations, for the purpose of Item 3 of Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘iron’ (also known as elemental iron) as a therapeutically active ingredient, subject to the following conditions:

the preparations contain a daily dose of not more than 24 mg of iron; and
the primary pack contains not more than 750 mg of iron if the divided preparations contain more than 5 mg of iron per dosage unit; and
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 24th day of June 2014

(Signed by)

Professor John Skerritt

Delegate of the Minister for Health