Therapeutic Goods (Listing) Notice 2013 (No. 1)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2013 (No. 1)

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 ‘concentrated omega-3-triglycerides - squid’ as a therapeutically active ingredient, subject to the following conditions:

• the preparations are for oral use only; and

• the ‘concentrated omega-3-triglycerides - squid’ is obtained from species of the order Teuthida of the class Cephalopoda; and

• the ‘concentrated omega-3-triglycerides - squid’ is in combination with other ingredients; and

• the preparations are presented in a therapeutic dosage form for therapeutic use; and

• the container, and any other packaging for the goods, is labelled with the warning –

  • “DERIVED FROM SEAFOOD”.

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 10th day of May 2013

(Signed by)

John Skerritt

Delegate of the Minister for Health