Medicines information kit
Essentially, any product for which therapeutic claims are made must be listed or registered in the Australian Register of Therapeutic Goods (ARTG) <http://www.tga.gov.au/docs/html/artg.htm> before it can be supplied in Australia. (Some exceptions do exist.)
This information kit, produced in November 1999, provides an introductory guide to listing or registering a medicine in the ARTG. (Therapeutic devices <http://www.tga.gov.au/devices/devices.htm> are dealt with in other publications).
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- Overview (pdf,1.24Mb)
An introductory roadmap to placing medicines on the ARTG. - Listed medicines (pdf,1.22Mb)
A roadmap to listing medicines in the ARTG. - Non-prescription (low risk) registered medicines (pdf,1.33Mb)
A roadmap to registering non-prescription (low risk) medicines in the ARTG. - Prescription (high risk) registered medicines (pdf,1.33Mb)
A roadmap to registering prescription (high risk) medicines in the ARTG. - New complementary medicine substances (pdf,1.26Mb)
A roadmap for the approval of new complementary medicine substances for listed or registered products in the ARTG.
