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This gazette
— p 167
Section 14 and 14A Notice
Administered by: Health
Published Date 16 Jan 2013
Printed Publication Date 16 Jan 2013

 

 

THERAPEUTIC GOODS ACT 1989

 

SECTION 14 AND 14A NOTICE

 

 

 

On October 22 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 product ethinyloestradiol/levonorgestrel (MICROGYNON 50 ED) 50 microgram/125 microgram tablet blister pack [Aust R 10695] by Bayer Australia Ltd, Pymble NSW (“the Company”):

 

That does not conform with paragraphs 3(2)(i) and 3(13)(b) of Therapeutic Goods Order 69, in that the abbreviation for the word ‘expiry’ is represented on the blister foil labels as ‘ecp’ instead of ‘exp’.

 

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.       This consent to supply applies to the foil labels of batch WEH57H of the product ethinyloestradiol/levonorgestrel (MICROGYNON 50 ED) 50 microgram/125 microgram tablet blister pack [Aust R 10695] only, comprising 40,000 units

2.       The foil labels to which this consent applies are identical those supplied with correspondence from the Company dated September 20 2012, where the abbreviation ‘ecp’ is used instead of ‘exp’.

3.       No other changes have been made to batch WEH57H of the product ethinyloestradiol/levonorgestrel (MICROGYNON 50 ED) 50 microgram/125 microgram tablet blister pack [Aust R 10695], except for the formatting/design changes to the labels approved by the delegate.