GS1 NZs Submission on General Requirements for Medicine Packaging Labelling
THE PROPOSED JOINT AUSTRALIA-NEW ZEALAND THERAPEUTIC PRODUCTS REGULATORY
AGENCY
The information currently required to be present on the labels of medicines
regulated by the Therapeutic Goods Administration (TGA) in Australia,
and by Medsafe in New Zealand, is specified in Therapeutic Goods Order
69 (TGO 69) General requirements for labels for medicines (as amended
by TGO 69A), and in the Regulations to the Medicines Act (1981), respectively.
These requirements can be accessed via the following links to the websites
of the two agencies: http://www.tga.gov.au/docs/html/tgo/tgo69.htm
and http://www.medsafe.govt.nz.
With the proposed formation of a joint Australia – New Zealand agency
for the regulation of therapeutic products, to commence operation by 1
July 2006, it was agreed by the responsible Ministers that a single, harmonised
standard for medicine labels be established. It was further decided that
an expert committee, comprising members from both countries and having
a variety of relevant backgrounds, be established to develop and make
recommendations on such a standard.
The expert committee met on three occasions towards the end of 2004 and
developed a draft set of requirements for the labelling of medicines.
This draft takes into account existing requirements for medicine labels
in both Australia and New Zealand, and in developing the draft, the committee
considered ways of improving the quality of medicine labels, as well as
problems identified with the current requirements.
Click
Here for GS1 New Zealand's Submission (PDF 6MB)
Click
Here to go to GS1global Healthcare site
