You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

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:

  • 4 Quality
  • 4A Manufacture
  • 4B Formulation
  • 4C Starting material specification
  • 4D Finished product specification
  • 4E Stability testing
  • 4F Microbioloigcal testing
  • 5A Product name
  • 5B Labelling
  • 5C Product Information
  • 5D Consumer Medicines Information
  • 5E Changes to Scheduling
  • 6A Efficacy and safety
  • 6B New substances
  • 9 MEC Guidelines

with appendices

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

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

These documents are provided for historical reference only. Please refer to the Australian regulatory guidelines for OTC medicines (ARGOM) for the most current information.