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— pp 2887 - 2888
Section 14 and 14A Notice
Administered by: Health
Published Date 31 Oct 2012
Printed Publication Date 31 Oct 2012

 

 

THERAPEUTIC GOODS ACT 1989

 

SECTION 14 AND 14A NOTICE

 

 

 

On August 23 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 fluorescein (Fluorescite) 500 mg/5 mL (as sodium) injection vial [Aust R 124267] by Alcon Laboratories (Australia) Pty Ltd, Frenchs Forest NSW (“the Company”):

 

That does not conform with paragraphs 3(2)(c) and 4(7)(c), 3(2)(g), 3(2)(j), 3(2)(k) and 3(14), 3(2)(l), 3(5)(b)(i) and 3(5)(b)(ii) of the Therapeutic Goods Order 69, in that:

·         the excipients and their quantities are not listed on the carton labels

·         the quantity of the active ingredient is expressed differently on the carton labels to the approved form

·         warning statements and signal headings are not included on the carton labels

·         the storage condition is expressed differently on the carton labels to that of the approved form

·         the directions for use are not included on the carton labels

·         the address of the Company is not included on the carton labels

·         warning statements regarding the absence of antimicrobial preservative and for single use are not included on the carton labels

 

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 for batch number 206017F only.

2.       The labels to which this consent applies are those supplied by the Company in correspondence dated July 2 2012, being the United States versions, except that the Aust R number and Australian sponsor name are overstickered on the cartons.

3.       No other changes have been made to the product fluorescein (Fluorescite) 500 mg/5 mL (as sodium) injection [Aust R 124267], except as approved by the TGA.

4.       The Dear Healthcare provider letter supplied by the Company in correspondence dated August 22 2012, which explains the circumstances relating to this consent, will be supplied with the product.

5.       The US product leaflet will be removed from the packs and be replaced with the approved Australian version.