Federal Register of Legislation - Australian Government

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Notices & Notifications as made
This notice has the effect of requiring that therapeutic goods that contain ‘menaquinone 7’ as a therapeutically active ingredient, subject to certain conditions, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.
Administered by: Health
Made 18 May 2014
Registered 19 Jun 2014
Tabled HR 23 Jun 2014
Tabled Senate 23 Jun 2014
Date of repeal 21 Oct 2016
Repealed by Therapeutic Goods (Repeal of Listing Notices) Notice 2016

 

 

Therapeutic Goods Act 1989

 

 

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 ‘Menaquinone 7’ as a therapeutically active ingredient, subject to the following conditions:

o   the preparations are for oral use only; and

o   the preparations provide not more than 180 mg of ‘menaquinone 7’ per daily dose in adults; and

o   the preparations provide not more than 90 mg of ‘menaquinone 7’ per daily dose in children between 10 to 18 years of age; and

o   the preparations provide not more than 45 mg of ‘menaquinone 7’ per daily dose in children less than 10 years of age.

 

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 18th day of May 2014

 

 

 

(Signed by)

 

John Skerritt

Delegate of the Minister for Health