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Australian regulatory guidelines for OTC medicines (ARGOM) (archived)
Related information
ARGOM amendment schedule
Changes to the Australian Regulatory Guidelines for Over-The-Counter Medicines (ARGOM) from 1 July 2003 to 9 November 2012.
| Details of change | Date |
|---|---|
| Replaced by individual guidelines | 15/04/2013 |
| Chapter 10 Sunscreens replaced by Australian Regulatory Guidelines for Sunscreens | 09/11/2012 |
|
Replace chapters:
with appendices |
12/10/2012 |
| Amend Chapter 5C to reflect changes introduced by the Restricted Medicine Specification 2011, and the Form for providing product information for a restricted medicine or other medicine in relation to which the Secretary requires product information to be provided. | 16/05/2011 |
| Amend table in Chapter 10 (Sunscreen's, page 10.13) - "Diethylamino Hydroxybenzoyl hexyl benzoate" added | 24/06/2009 |
| Amend table 'Sunscreening agents permitted as active ingredients in listed products' in Chapter 10 - "Polysilicone-15" added | 18/08/2006 |
| Add 'Codeine' guideline to Chapter 9 (MEC guidelines) | 28/06/2006 |
| Update reference to prescription medicines guideline in Chapter 4E ('Stability testing', page 4E.1) from AGRD1 to ARGPM | 28/06/2006 |
| Amend table in Chapter 10 ('Sunscreens', page 10.14) - "Disodium phenyl dibenzimidazole tetrasulfonate" added | 31/08/2005 |
| Amend table in Chapter 10 ('Sunscreens', page 10.14) - "Drometrizole trisiloxane" added | 06/12/2004 |
| Amend table in Chapter 10 ('Sunscreens', page 10.14) - "Bemotrizinol" and "Methylene bisbenzotriazolyl tetramethylbutyl phenol" added | 22/11/2004 |
| Add statement at start of 'Umbrella branding' guideline in Chapter 5A (Presentation) as clarification of intent of guideline | 30/07/2004 |
| 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 | 25/06/2004 |
| Amend 'Products for nasal/oropharyngeal use' guideline in Chapter 4F (Microbiological testing) | 25/06/2004 |
| Delete 'Colouring agents' guideline from Chapter 9 (MEC guidelines) [the same information is included in Chapter 4B] | 25/06/2004 |
| Amend 'Colouring ingredients' guideline in Chapter 4B (Formulation) [following change to page 4C.4, Chapter 4C, above] | 25/06/2004 |
| 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 | 25/06/2004 |
| Correction of error in Chapter 10 ('Sunscreens') ["broad spectrum 30+ sunscreening preparations" (page 10.4) amended to "broad spectrum sunscreening preparations".] | 13/02/2004 |
| Add 'Umbrella branding' guideline to Chapter 5A (Presentation) | 13/02/2004 |
| Amend 'Nonoxinol 9' guideline in Chapter 9 (MEC guidelines) | 13/02/2004 |
| Amend 'Coal tar preparations' guideline in Chapter 9 (MEC guidelines) | 13.2.2004 |
| Amend table in Chapter 10 ('Sunscreens', page 10.14) – Maximum concentration for zinc oxide amended | 12/12/2003 |
| Amend 'Insecticidal products' – 'Head lice treatment products' guideline in Chapter 9 (MEC guidelines) | 01/12/2003 |
| Amend 'Sodium content' guideline in Chapter 9 (MEC guidelines) | 24/09/2003 |
| Add Chapter 10 (Sunscreens) | 24/09/2003 |
Previous versions of ARGOM sections
How to access a pdf or Word document
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These documents are provided for historical reference only. Please refer to the Australian regulatory guidelines for OTC medicines (ARGOM) for the most current information.
- ARGOM as at 9 November 2012
- ARGOM as at 11 October 2012 (pdf,1.05Mb)
- ARGOM as at 11 October 2012 (Microsoft Word,4.04Mb)
- Amendment date: 9 November 2012
- Details of change: Chapter 10 Sunscreens replaced by Australian Regulatory Guidelines for Sunscreens
- Amendment date: 12 October 2012
- Details of change:
- Chapter 4 Quality replaced with Appendix 2: Guidelines on Quality aspects of OTC applications
- Chapter 5 Presentation replaced with Appendix 3: Guidelines on presentation aspects of OTC applications
- Chapter 6A Efficacy and safety replaced with Appendix 1: Guidelines on safety and efficacy aspects of OTC applications
- Chapter 6B New substances replaced with Appendix 4: Guidelines on OTC application for new substances
- Chapter 9 MEC Guidelines replaced with Appendix 5: Guidelines on OTC applications for specific substances
- Details of change:
- Amendment date: 9 November 2012
- Chapter 5 'Product Information (PI)' at 16 May 2011 (pdf,143kb)
- Chapter 5 'Product Information (PI)' at 16 May 2011 (Microsoft Word,376kb)
- Amendment date: 16/05/2011
- Details of change: Added 'Introduction' and 'Form'
- Table in Chapter 10 'Sunscreens' (page 10.13 & 10.14) at 16 August 2006 (pdf,50kb)
- Amendment date: 24/06/2009
- Details of change: Amend table 'Sunscreening agents permitted as active ingredients in listed products' in Chapter 10
- Table in Chapter 10 'Sunscreens' (page 10.13 & 10.14) at 16 September 2005 (pdf,50kb)
- Amendment date: 18/08/2006
- 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)
