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— p 1220
Section 14 and 14A Notice
Administered by: Health
Published Date 15 May 2013
Printed Publication Date 15 May 2013

COMMONWEALTH OF AUSTRALIA

 

THERAPEUTIC GOODS ACT 1989

 

SECTION 14 AND 14A NOTICE

 

 

On 6 May 2013 delegate of the Secretary of the Department of Health and Ageing for the purposes of sections 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to the following:

 

(a)   the export by CSL Behring (Australia) Pty Ltd, 189-209 Camp Road, Broadmeadows VIC 3047 (the Company) of CSL Panama Human Coagulation Factor VIII for Injection 250 IU (AUSTL 132713); AND

 

(b)  for the above goods not to conform with the requirements of the current European Pharmacopeia monograph “Human Coagulation Factor VIII (Factor VIII coagulationis humanus), 01/2010:0275 corrected 7.6” in respect of the requirements that the amount of von Willebrand factor (vWF) in the container exceeds the upper limit of not more than 140% of the potency stated on the label.

 

Pursuant to section 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 Company will submit notification to the TGA for each batch of this product that is released under this exemption;

 

2.    The ratio of vWF to Factor VIII in product released under this exemption will nominally be 2.4:1 (the currently approved ratio for this product is 2:1). The vWF specifications will be:

 

·         250 IU human coagulation factor VIII/vial; 600 IU human vWF (range 360 to 840 IU);

 

  1. This consent applies until 31 March 2014.