THERAPEUTIC GOODS ACT 1989

SECTION 14 AND 14A NOTICE

On July 20 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 terlipressin (GLYPRESSIN) powder for injection [Aust R 177517] by Ferring Pharmaceuticals Pty Ltd, Pymble NSW (“the Company”):

That does not conform with paragraphs 3(2)(a), 3(2)(b), 3(2)(c), 3(2)(e), 3(2)(j), 3(5)(a)(ii) and 3(5)(b)(ii) of the Therapeutic Goods Order 69, in that the product name, quantity and proportions of the active ingredients, the name and expression of the dosage form, the storage conditions and the warning about single use in one patient only are expressed differently to the approved versions on the product 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 to the following batches only:

·         F13034DA, expiry date 06/2014, 42 units of 5 x 1 mL

·         F16534BA, expiry date 01/2015, 335 units of 5 x 1 mL

·         F15998CA, expiry date 11/2014, 618 units of 5 x 1 mL

2.       The labels which are the subject of this consent to supply are those which have been used for the product while it has been supplied under the Special Access Scheme (copies of which were supplied by the Company in correspondence dated June 25 2012).

3.       No other changes have been made to the product, except for changes approved by the TGA (site of product release: Ferring International Centre SA, Switzerland).

4.       The Dear Healthcare Professional letter, provided by the Company in correspondence from the Company dated July 10 2012, which explains the circumstances surrounding the supply of these batches, will be supplied with the batches to which this consent applies. The letter will be accompanied by a copy of the approved Australian Product Information.

5.       The carton labels for the affected batches will be overstickered with the Australian sponsor address details and the Aust R number.