Commonwealth legislation

Therapeutic Goods (Listing) Notice 2015 (No. 1)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

2/10 complexity

This notice permits vitamin supplements containing Ubiquinol‑10 (an active form of CoQ10) to be sold in Australia as listed medicines, affecting manufacturers, retailers and consumers. Products must be oral, limit Ubiquinol‑10 (including ubidecarenone) to 300 mg/day, and carry a warning about warfarin interactions. It’s a temporary approval replacing the 2012 notice until permanent rules are updated.

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Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2015 (No. 1).

Therapeutic Goods (Listing) Notice 2015 (No. 1)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2015 (No. 1)

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:

(a) REVOKE Therapeutic Goods (Listing) Notice 2012 (No.3); and

(b) 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 ‘Ubiquinol-10’ as a therapeutically active ingredient, subject to the following conditions:

the preparations are for oral use only; and the preparations provide not more than 300 mg ubiquinol-10 per daily dose; and when used in combination with ubidecarenone, the preparations provide not more than 300 mg of ubiquinol-10 and ubidecarenone combined per daily dose; and the container, and any other packaging, for the preparation is labelled with the following warning:

“Not to be taken, if on warfarin therapy, without medical advice”.

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 5th day of January 2015

(Signed by)

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 2015 (No. 1)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2015 (No. 1)

(a) REVOKE Therapeutic Goods (Listing) Notice 2012 (No.3); and

(b) 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 ‘Ubiquinol-10’ as a therapeutically active ingredient, subject to the following conditions:

the preparations are for oral use only; and the preparations provide not more than 300 mg ubiquinol-10 per daily dose; and when used in combination with ubidecarenone, the preparations provide not more than 300 mg of ubiquinol-10 and ubidecarenone combined per daily dose; and the container, and any other packaging, for the preparation is labelled with the following warning:

“Not to be taken, if on warfarin therapy, without medical advice”.

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

Dated this 5th day of January 2015

(Signed by)

John Skerritt

Delegate of the Minister for Health