Commonwealth legislation

Therapeutic Goods (Listing) Notice 2010 (No. 1)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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 permits oral supplements containing “Omega‑3 fish oil phytosterol esters” to be listed on the Australian Register of Therapeutic Goods (ARTG), letting manufacturers and suppliers sell this cholesterol‑management product while permanent rules are updated.

Listings must include two mandatory label warnings: a 3 g/day phytosterol dosage limit and that the product is not suitable for pregnant or lactating women. The approval automatically lapses once permanent regulations are in place.

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Therapeutic Goods (Listing) Notice 2010 (No. 1)

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Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2010 (No. 1)

I, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing 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 ARTG) for listed goods:

oral preparations, for the purpose of Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘Omega-3 fish oil phytosterol esters’ as a therapeutically active ingredient.

The inclusion of such goods in that Part of the Register is subject to the following condition:

the product label must include the following advisory statements:

- “There is no benefit from taking more than 3g/day of phytosterols from all sources”; and

- “Not suitable for pregnant or lactating women”.

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 ARTG for listed goods.

Dated this 15th day of February 2010

(signed by)

Rohan Hammett

Delegate of the Minister for Health and Ageing

Source text

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

1 Therapeutic Goods (Listing) Notice 2010 (No. 1)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2010 (No. 1)

oral preparations, for the purpose of Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘Omega-3 fish oil phytosterol esters’ as a therapeutically active ingredient.

The inclusion of such goods in that Part of the Register is subject to the following condition:

the product label must include the following advisory statements:

- “There is no benefit from taking more than 3g/day of phytosterols from all sources”; and

- “Not suitable for pregnant or lactating women”.

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

Dated this 15th day of February 2010

(signed by)

Rohan Hammett

Delegate of the Minister for Health and Ageing