Therapeutic Goods Act 1989

THERAPEUTIC GOODS ORDER NO. 69C

Amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines

I, ROHAN HAMMETT, delegate of the Minister for Health and Ageing for the purposes of the exercise of the Minister’s powers under section 10 of the Therapeutic Goods Act 1989 and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of that Act, hereby AMEND Therapeutic Goods Order No. 69 General requirements for labels for medicines, made on 27 August 2001, in the manner set out below.

1. Under clause 2 ‘Interpretation’,

DELETE the current definition of ‘Required Advisory Statements for Medicine Labels’; and

REPLACE with the following new definition:

‘Required Advisory Statements for Medicine Labels’ means the document Required Advisory Statements for Medicine Labels (September 2008) published by the Therapeutic Goods Administration on its website (http://www.tga.gov.au).

2. Under clause 4 ‘Expression of quantity or proportion of active ingredient in medicines’,

DELETE subclause 4(13) commencing ‘for preparations containing Vitamin A - ’; and

REPLACE with the following new subclause:

4(13) for preparations containing Vitamin A – as the quantity or proportion of Vitamin A expressed in terms of retinol equivalents (R.E.)

This Order commences on the later date of the day after it is registered on the Federal Register of Legislative Instruments or 23 April 2009.

Dated this   sixth day of March 2009.

(Signed by)

Rohan Hammett

DELEGATE OF THE MINISTER FOR HEALTH AND AGEING