Federal Register of Legislation - Australian Government

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Notices & Notifications as made
The notice has the effect of requiring that therapeutic goods containing DHA/EPA rich Schizochytrium algal oil as a therapeutically active ingredient be included in the part of Australian Register of Therapeutic Goods for listed goods, subject to a number of important conditions.
Administered by: Health
Made 01 Nov 2013
Registered 12 Nov 2013
Tabled HR 18 Nov 2013
Tabled Senate 02 Dec 2013
Date of repeal 21 Oct 2016
Repealed by Therapeutic Goods (Repeal of Listing Notices) Notice 2016

 

Therapeutic Goods Act 1989

 

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:

o   the preparations are for oral use only; and

o   the ratio of docosahexaenoic acid (DHA) to eicosapentaenoic acid (EPA) in DHA/EPA rich Schizochytrium algal oil’ is 2:1; and

o   that DHA/EPA rich Schizochytrium algal oil’ is present in combination with other ingredients; and

o   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