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— p 271
Section 14 and 14A Notice
Administered by: Health
Published Date 30 Jan 2013
Printed Publication Date 30 Jan 2013

THERAPEUTIC GOODS ACT 1989

 

SECTION 14 AND 14A NOTICE

 

 

 

On December 12 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:

 

(a)   the supply of the following products by Link Medical Products Pty Ltd, Warriewood NSW (“the Company”):

·         adrenaline (ANAPEN 300) 300 microgram/0.3 mL injection syringe auto-injector [Aust R 134653]

·         adrenaline (ANAPEN 150) 150 microgram/0.3 mL injection syringe auto-injector [Aust R 135008]

 

That do not conform with paragraph 3(2)(a) of Therapeutic Goods Order 69, in that the previous product names (trade names) are used on the vial and carton labels instead of the new product names.

 

Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:

 

1.       The consent applies until July 01 2013.

2.       The vial and carton labels to which this consent applies are identical to those provided in correspondence from the Company dated November 14 2012:

a.       Those for the 300 microgram strength have the previous product name ‘Anapen’ instead of the new product name ‘Anapen 300’

b.       Those for the 150 microgram strength have the previous product name ‘Anapen Junior’ instead of the new product name ‘Anapen 150’

c.       The previous version of the product information, referring to the previous product names, is supplied with the products.

3.       No other changes have been made to the products:

·         adrenaline (ANAPEN) 300 microgram/0.3 mL injection syringe auto-injector [Aust R 134653]

·         adrenaline (ANAPEN) 150 microgram/0.3 mL injection syringe auto-injector [Aust R 135008]

4.       The other registered strength ‘Anapen 500’ will not be supplied during the consent period (until after July 01 2013).