General requirement for labels for medicGeneral requirement for labels for medicines

General requirement for labels for medicines

I, Terry Slater, delegate of the Minister for Health and Aged Care, 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:

(a) REVOKE the following orders:

(i) on and from 1 July 2004, Therapeutic Goods Order No. 48 entitled ‘General

requirements for labels for drug products’;

(ii) on and from 1 July 2004, Therapeutic Goods Order No. 62 entitled

‘Amendment to Therapeutic Goods Order No. 48 - General requirements

for labels for drug products’;

(iii) on and from the date this Order is gazetted, Therapeutic Goods Order

No. 55 entitled ‘Amendment to Therapeutic Goods Order No. 48 - General

requirements for labels for drug products’;

(iv) on and from the date this Order is gazetted, Therapeutic Goods Order

No. 55A entitled ‘Amendment to Therapeutic Goods Order No. 55 -

Amendment to Therapeutic Goods Order No. 48 - General requirements for

labels for drug products’; AND

(b) DETERMINE that, subject to subparagraphs (i), (ii), (iii) and (iv), therapeutic

goods to which this Order applies must be labelled in accordance with the

requirements of this Order:

(i) therapeutic goods that are included in an application lodged under

section 23 of the Therapeutic Goods Act 1989 ("the Act"), being an

application lodged before 1 January 2002, must, until 1 July 2004, comply

with either this Order or Therapeutic Goods Order No.48 ‘General

requirements for labels for drug products’, as modified by Therapeutic

Goods Order No. 62;

(ii) therapeutic goods that are included in an application lodged under

section 23 of the Act, being an application lodged before 1 January 2002,

must comply with this Order from 2 July 2004;

(iii) therapeutic goods that are included in an application under section 23 of the

Act lodged on or after 1 January 2002 must comply with this Order;

(iv) therapeutic goods that are subject to this Order but which are not included

in an application made under section 23 of the Act must comply with this

Order by 1 July 2004.

This Order includes the First Schedule and the Second Schedule to this Order.

This Order commences from the day it is gazetted in the Commonwealth Gazette.