Commonwealth legislation

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

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This Act has been repealed and is no longer in force. It is retained for historical reference.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 levomefolate calcium (a form of folate) to be listed on the Australian Register of Therapeutic Goods (ARTG), creating a legal pathway for their sale. It affects manufacturers, suppliers, and consumers—particularly pregnant people or those planning pregnancy.

Products must be oral and limited to 500 µg levomefolic acid per daily dose, or a combined total of all folates no greater than 500 µg. This cap aims to enable supply while protecting consumers.

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Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2015 (No. 5).

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

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

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

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

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

Therapeutic Goods Act 1989

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

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

the preparation is for oral use only; and
either

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