Consent given pursuant to Sections 14 and 14A for the supply of therapeutic goods specified - Merck Sharp & Dohme Australia

COMMONWEALTH OF AUSTRALIA

Department of Health
Therapeutic Goods Administration

THERAPEUTIC GOODS ACT 1989

Section 14 and 14A Notice

On December 24 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), by application of                           Merck Sharp & Dohme Australia Pty Ltd, gave consent to the supply of:

Betamethasone (DIPROSONE) (as dipropionate) 0.47mg/mL lotion bottle [AUST R 18829] that does not conform with the requirements of the clause 3(1)(b)(ii) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the letter height for parts of the bottle label is less than the minimum requirement of 1.5 mm.

 The consent is effective from December 24 2014.

The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:

1. The bottle labels to which this consent applies are those supplied with the application, in which the text height for Directions for Use and Sponsor details is 1.3 mm, instead of the required minimum of 1.5 mm.
2. The bottles are supplied in their registered cartons, which have text heights compliant with the requirements of TGO 69.