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— p 1119
Section 14 and 14A Notice
Administered by: Health
Published Date 01 May 2013
Printed Publication Date 01 May 2013

SECTion 14 AND 14A NOTICE

 

I, Mayada Kayali, delegate of the Secretary to the Department of Health and Ageing for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (‘the Act’) hereby give my consent, pursuant to sections 14 and 14A of the Act, for iNova Pharmaceuticals (Australia) Pty Limited, Level 10 12 Help Street CHATSWOOD NSW 2067 to supply DIFFLAM MOUTH GEL tube (AUST R 48597) whose tube label does not comply with subclause 3(11)(c) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines in that the batch and expiry details on the tube label are not prefixed with the required prefixes.

 

Pursuant to section 15(1) of the Act, my consent is subject to the following condition:

 

1.       The product complies with all other aspects of the standard.

2.       The consent applies only to the batch numbers IN501301 and IN501304.

 

 

 

 

 

 

 

(Signed by)

 

Mayada Kayali

Delegate of the Secretary

Office of Medicines Authorisation

 

19 April 2013