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