Therapeutic Goods Act 1989
Therapeutic Goods (Listing) Notice 2014 (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, 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
Delegate of the Minister for Health