COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On November 5 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 supply
betamethasone (DIPROSONE) 0.47mg/mL (as dipropionate) lotion bottle [AUST R 18829] that does not conform with 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 November 5, 2014.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- 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.
- The bottles are supplied in their registered cartons, which have text heights compliant with the requirements of TGO 69.