Commonwealth legislation

Therapeutic Goods (Listing) Notice 2014 (No. 4)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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 temporarily fast-tracks topical skin-care products with urea as the therapeutic ingredient onto the Australian Register of Therapeutic Goods via the simpler “listed goods” route, permitting creams, lotions and similar preparations with up to 10% urea (w/w) for skin use. It lets manufacturers supply affordable urea moisturisers immediately without full registration, and will cease once permanent regulations take effect.

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Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2014 (No. 4).

Therapeutic Goods (Listing) Notice 2014 (No. 4)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2014 (No. 4)

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

o the preparations are for topical use only; and

o the concentration of urea is not more than 10 per cent (w/w).

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 3rd day of September 2014

(Signed by)

John Skerritt

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 2014 (No. 4)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2014 (No. 4)

preparations, for the purpose of Item 3 of Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘urea’ as a therapeutically active ingredient, subject to the following conditions:

o the preparations are for topical use only; and

o the concentration of urea is not more than 10 per cent (w/w).

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

Dated this 3rd day of September 2014

(Signed by)

John Skerritt

Delegate of the Minister for Health