Legislation changes & proposed legislation changes
2009
- Proposed standards and Code of GMP for human blood and blood components, human tissues and human cellular therapies
<http://www.tga.gov.au/bt/consult/drbloodstandards.htm>
7 December 2009 - Proposed new Therapeutic Goods Orders: Standard for human albumin, Standard for water for injection for parenteral medicines, Order under section 3C(1) of the Act
<http://www.tga.gov.au/legis/consult/tgo-drapo.htm>
22 September 2009 - Proposed New Therapeutic Goods Order: Standard for Heparin
<http://www.tga.gov.au/legis/consult/tgo-drheparin.htm>
9 September 2009 - Therapeutic Goods Amendment (2009 Measures No 1) Act 2009
<http://www.tga.gov.au/regreform/regreform2.htm>
received royal assent on 27 August 2009 - Review of Schedule 1 to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80)
<http://www.tga.gov.au/legis/consult/tgo80.htm>
25 August 2009 - Therapeutic Goods Amendment (2009 Measures No 2) Bill 2009
<http://www.tga.gov.au/regreform/regreform3.htm>
introduced into House of Representatives 24 June 2009
passed without amendment by the House of Representatives on 19 August 2009
expected to be debated by the Senate during the week commencing 7 September 2009 - Questions and answers relating to the additional default standards legislation
<http://www.tga.gov.au/legis/regreform/qa-defaultstandards.htm>
19 June 2009 - Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009
<http://www.tga.gov.au/regreform/index.htm>
received royal assent on 17 June 2009 - Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009
<http://www.tga.gov.au/regreform/index.htm>
introduced to Parliament on 19 May 2009 - Intention to amend the definition of 'British Pharmacopoeia' under the Therapeutic Goods Act 1989
January 2009
2008
- Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 and explanatory memorandum
introduced into Parliament 3 December 2009 - Intention to amend Therapeutic goods Order No. 69 - General requirements for labels for medicines
December 2008 - Stakeholder Consultation on Updated Medical Device Standards Orders (MDSOs) and Conformity Assessment Standards Orders (CASOs)
July 2008 - Draft Therapeutic Goods Order No. 78 General requirements for tablets and capsules
January 2008 - Draft Therapeutic Goods Order No. 77 Microbiological standards for medicines
January 2008 - Draft Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines
January 2008
2007
- Stakeholder consultation: Updated Medical Device Standards Orders (MDSOs) and Conformity Assessment Standards Orders (CASOs)
December 2007 - Update to definition of 'British Pharmacopoeia' under the Therapeutic Goods Act 1989 - adoption of British Pharmacopoeia 2008 (BP 2008)
December 2007 - Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 - Information about Sponsor
November 2007 - Update to definition of 'British Pharmacopoeia' under the Therapeutic Goods Act 1989 - adoption of British Pharmacopoeia 2007 (BP 2007)
January 2007
2005 - 2003
- New substances approved for inclusion in Listed medicines
March 2005 - Amendments to the Therapeutic Goods Act 1989
May 2003