Australian regulatory guidelines for OTC medicines (ARGOM) - amendment schedule
Changes since 1 July 2003
Links to previous versions
These documents are provided for historical reference only. Please refer to the Australian regulatory guidelines for OTC medicines (ARGOM) <http://www.tga.gov.au/docs/html/argom.htm> for the most current information.
- Table in Chapter 10 'Sunscreens' (page 10.13 & 10.14) at 16 September 2005 (30kb)
- Amendment date: 18/08/06
- Details of change: Amend table 'Sunscreening agents permitted as active ingredients in listed products' in Chapter 10
- No previous version
- Amendment date: 28/06/2006
- Details of change: Add 'Codeine' guideline to Chapter 9 (MEC guidelines)
- Stability testing (Chapter 4E) at 1 July 2003 (pdf,32kb)
- Amendment date: 28/06/2006
- Details of change: Update reference to prescription medicines guideline in Chapter 4E ('Stability testing', page 4E.1) from AGRD1 to ARGPM
- Table in Chapter 10 'Sunscreens' (page 10.14) at 6 December 2004 (pdf,48kb)
- Amendment date: 31/08/2005
- Details of change: Updated table in Chapter 10 ('Sunscreens', pages 10.13 & 10.14)
- Table in Chapter 10 'Sunscreens' (page 10.14) at 22 November 2004 (pdf,51kb)
- Amendment date: 06/12/2004
- Details of change: Updated table in Chapter 10 ('Sunscreens', pages 10.13 & 10.14)
- Colourings for use in pharmaceuticals for ingestion (Chapter 4C) at 1 July 2003 (pdf,34kb)
- Amendment date: 25/06/2004
- Details of change: Amend 'Colourings for use in pharmaceuticals for ingestion' guideline in Chapter 4C (Starting material specification') - heading amended to 'Colours permitted in medicines for oral use' and table replaced by link to TGA website
- Colourings ingredients (Chapter 4B) at 1 July 2003 (pdf,27kb)
- Amendment date: 25/06/2004
- Details of change: Amend 'Colouring ingredients' guideline in Chapter 4B (Formulation) [following change to page 4C.4, Chapter 4C, above]
- Colouring agents (Chapter 9) at 1 July 2003 (pdf,27kb)
- Amendment date: 25/06/2004
- Details of change: Delete 'Colouring agents' guideline from Chapter 9 (MEC guidelines) [the same information is included in Chapter 4B]
- Products for nasal/oropharyngeal use (Chapter 4F) at 1 July 2003 (pdf,27kb)
- Amendment date: 25/06/2004
- Details of change: Amend 'Products for nasal/oropharyngeal use' guideline in Chapter 4F (Microbiological testing)
- Table in Chapter 10 'Sunscreens' (page 10.14) at 12 December 2003 (pdf,36kb)
- Amendment date: 25/06/2004
- Details of change: Amend table in Chapter 10 ('Sunscreens', page 10.14) - name "Benzophenone-4" deleted from column 1 and "Sulisobenzone" moved from column 2 to column 1
- Coal tar guideline (Chapter 9) at 1 July 2003 (pdf,17kb)
- Amendment date: 13/02/2004
- Details of change: Amend 'Coal tar preparations' guideline in Chapter 9 (MEC guidelines)
- Nonoxinol 9 guideline (Chapter 9) at 1 July 2003 (pdf,16kb)
- Amendment date: 13/02/2004
- Details of change: Amend 'Nonoxinol 9' guideline in Chapter 9 (MEC guidelines)
- no previous version
- Amendment date: 13/02/2004
- Details of change: Add 'Umbrella branding' guideline to Chapter 5A
- Sunscreens Page 10.4 (Chapter 10) at 24 September 2003 (pdf,59kb)
- Amendment date: 13/02/2004
- Details of change: Correct reference to skin ageing claims in Chapter 10 (Sunscreens) Page 10.4
- Zinc oxide guideline (Chapter 10) at 1 December 2003 (pdf,22kb)
- Amendment date: 12/12/2003
- Details of change: Amendment to the maximum concentration of zinc oxide in listed sunscreens in Chapter 10 (Sunscreens)
- Head lice treatment products guideline (Chapter 9) at 1 July 2003 (pdf,19kb)
- Amendment date: 01/12/2003
- Details of change: Amend 'Insecticidal products' - 'Head lice treatment products' guideline in Chapter 9 (MEC guidelines)
- Sodium content guideline (Chapter 9) at 1 July 2003 (pdf,20kb)
- Amendment date: 24/09/2003
- Details of change: Amend 'Sodium content' guideline in Chapter 9 (MEC guidelines)
- No previous version
- Amendment date: 24/09/2003
- Details of change: Add Chapter 10 (Sunscreens)