Australian therapeutic products legislation
The Therapeutic Goods Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, including advertising, labelling, product appearance and appeal guidelines. Some provisions such as the scheduling of substances and the safe storage of therapeutic goods, are covered by the relevant State or Territory legislation.
Australian legislation in full text is available from the Attorney General's Department's ComLaw website <http://www.comlaw.gov.au> (incorporating the Federal Register of Legislative Instruments (FRLI)). For details on how to obtain hardcopies of the Acts and Regulations see the Government Publications Register <http://www.publications.gov.au/legislation.html>.
If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
BioRegs Online <http://www.bioregs.gov.au> offers comprehensive information about the regulation and development of biotechnology and related products in Australia.
Acts/regulations
<http://www.comlaw.gov.au>
Related information
- Commonwealth of Australia Gazette notices
<http://www.ag.gov.au/portal/govgazoneline.nsf> - Australia-US Free Trade Agreement
<http://www.tga.gov.au/international/usfta.htm> - Review of drugs, poisons and controlled substances legislation (the Galbally Review)
<http://www.tga.gov.au/docs/html/rdpdfr.htm> - Legislation changes & proposed changes
<http://www.tga.gov.au/legis/changes.htm>
Legislative instruments
- Excluded goods order No. 1 of 2008
<http://www.tga.gov.au/legis/tgeg0801.htm> - Groups orders
<http://www.tga.gov.au/legis/groups.htm> - Listing notices
<http://www.tga.gov.au/legis/listing.htm> - Manufacturing principles
<http://www.tga.gov.au/legis/manufp.htm> - Medical devices notices & standards orders
<http://www.tga.gov.au/legis/devices.htm> - Therapeutic Goods Orders (TGOs)
<http://www.tga.gov.au/legis/tgo.htm> - Therapeutic Goods Advertising Code
<http://www.tga.gov.au/advert/tgac.htm> - Definition of British Pharmacopoeia
<http://www.tga.gov.au/legis/bp.htm> - Order that goods are therapeutic goods No. 1 of 1999
<http://www.tga.gov.au/legis/ogtg9901.htm> - Single therapeutic goods order
<http://www.tga.gov.au/docs/html/dr4app19.htm>