Commonwealth legislation

Therapeutic Goods (Listing) Notice 2013 (No. 3)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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 supplements containing oil from Schizochytrium algae to be listed on the Australian Register of Therapeutic Goods, allowing them to be legally sold while permanent rules are developed. It only covers oral medicinal forms that mix the oil with other ingredients and meet a 2:1 DHA-to-EPA ratio. This affects manufacturers, sellers and consumers by providing immediate market access pending regulatory change.

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Current sections

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Therapeutic Goods (Listing) Notice 2013 (No. 3)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2013 (No. 3)

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 ‘DHA/EPA rich Schizochytrium algal oil’ as a therapeutically active ingredient, subject to the following conditions:
- the preparations are for oral use only; and
- the ratio of docosahexaenoic acid (DHA) to eicosapentaenoic acid (EPA) in ‘DHA/EPA rich Schizochytrium algal oil’ is 2:1; and
- that ‘DHA/EPA rich Schizochytrium algal oil’ is present in combination with other ingredients; and
- the preparations are presented in a therapeutic dosage form for therapeutic use.

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 1st day of November 2013

(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 2013 (No. 3)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2013 (No. 3)

preparations, for the purpose of Item 3 of Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘DHA/EPA rich Schizochytrium algal oil’ as a therapeutically active ingredient, subject to the following conditions:
- the preparations are for oral use only; and
- the ratio of docosahexaenoic acid (DHA) to eicosapentaenoic acid (EPA) in ‘DHA/EPA rich Schizochytrium algal oil’ is 2:1; and
- that ‘DHA/EPA rich Schizochytrium algal oil’ is present in combination with other ingredients; and
- the preparations are presented in a therapeutic dosage form for therapeutic use.

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

Dated this 1st day of November 2013

(Signed by)

John Skerritt

Delegate of the Minister for Health