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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:

  • 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

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

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Previous versions of ARGOM sections

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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.

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