Therapeutic Goods (Listing) Notice 2015 (No. 5) (Cth)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2015 (No. 5)

I, Trisha Garrett, First Assistant Secretary, Medicines Regulation of the Regulatory Services Group, delegate of the Minister for Health for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods for listed goods:

preparations that contain ‘Levomefolate calcium’ as a therapeutically active ingredient, subject to the following conditions:

·     the preparation is for oral use only; and

·     either

o   the preparation provides not more than 500 µg of Levomefolic acid from Levomefolate calcium per daily dose; or

o   when used in combination with folic acid, folinic acid and/or their derivatives, the preparation provides not more than a total of 500 µg of folic acid, folinic acid and/or their derivatives in total per daily dose.

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

Dated this 17 day of September 2015

(Signed by)

Trisha Garrett

Delegate of the Minister for Health