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Section 14 and 14A Notice
Administered by: Health
Published Date 14 Aug 2013

COMMONWEALTH OF AUSTRALIA

Department of Health and Ageing
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

 

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  Merck Sharp & Dohme (Australia) Pty Limited to supply the following batches of CHILDREN'S CLARATYNE loratadine 5 mg chewable tablet blister pack (AUST R 169329) which do not comply with subclauses 3(2)(h) and (i) of the Therapeutic Goods Order No. 69 – General Requirement for labels for medicines (TGO69) such that the blister packs do not include the prefixes for the batch number and expiry date:

Pack size

Batch No.

Batch size (units)

Expiry Date

10

2P01AR

81000

09/2014

10

3H01AR

98820

04/2015

30

3H02AR

31000

04/2015

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

  1. The consent applies to the batches listed in the table above only;
  2. The medicine comply with all other aspects of TGO69;
  3. The medicine labels include the batch number and expiry date of the goods.

 

(Signed by)

Mayada Kayali

Delegate of the Secretary

Office of Medicines Authorisation

9 August 2013