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Consultation: Australian regulatory guidelines for over-the-counter medicines (ARGOM) - Stage 1

12 October 2012

This consultation closed on 10 February 2012

Invitation to comment

The TGA sought comments from interested parties on proposed revisions to the Australian regulatory guidelines for over-the-counter medicines (ARGOM).

Consultation documents

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Appendix 1 Guidelines on safety and efficacy aspects of OTC application

Appendix 2 Guidelines on quality aspects of OTC application

Appendix 3 Guidelines on presentation aspects of OTC application

Appendix 4 Guidelines on OTC application for new substances

Appendix 5 Guidelines on OTC application for specific products

ARGOM 2003 updated to include reference to appendices


Any questions relating to submissions should be directed to the ARGOM Review Project Manager by email to or by telephone to 02 6232 8160.


Document released for consultation on Monday, 28 November 2011.

Interested parties responded by close of business Friday, 10 February 2012.

Feedback has now been released following consideration of submissions (see 'What will happen').


The Australian Regulatory Guidelines for Over-the-Counter Medicines (ARGOM) is a guideline document which seeks to:

  • provide information to help sponsors of over-the-counter (OTC) medicines to meet their obligations under therapeutic goods legislation;
  • ensure that applications to the TGA relating to OTC medicines uniformly meet all essential regulatory requirements so that applications may be processed successfully within minimum timeframes; and
  • clarify processes leading to the Registration and Listing of OTC medicines in the Australian Register of Therapeutic Goods (ARTG).

Substantial revision of the existing published ARGOM has been undertaken in consultation with a working group composed of representatives from the Therapeutic Goods Administration (TGA), and the Australian pharmaceutical and cosmetics industry associations.

The TGA has commenced reviewing the market authorisation process for OTC medicines. It is expected that this work will introduce revised market authorisation processes for OTC medicines. Consequently, the consultation process for the revised ARGOM will be divided into 2 stages.

Stage 1

The first stage of the consultation process involves releasing the five appendices for consultation, which have been chosen on the basis that they are intended to provide sponsors with greater clarity on the data requirements for submitting effective OTC medicine applications to the TGA.

Stage 2

It is envisaged that the remaining ARGOM chapters which are associated with the process and format of OTC medicine applications, as well as post-market activities, will be released for consultation in the second stage, once revised processes have been developed, consulted on and implemented.

Changes to the format of ARGOM

In order to be consistent with other TGA regulatory guidelines and provide a structure that will allow for an easier process in updating ARGOM in the future, the documents have been re-formatted into appendices.

The architectural change to the ARGOM means that the main body of the guideline will specifically deal with the process and format of medicine applications whilst referencing the appendices for specific details on data requirements.

The following selected chapters of ARGOM have been re-formatted as appendices for consultation:

Previous title - Chapter New title - Appendix
6A Efficacy and safety; Appendix 1: Guidelines on safety and efficacy aspects of OTC application
  • 4 Quality
  • 4A Manufacture
  • 4B Formulation
  • 4C Starting material specification
  • 4D Finished product specification
  • 4E Stability testing
  • 4F Microbioloigcal testing
Appendix 2: Guidelines on quality aspects of OTC application
  • 5A Product name
  • 5B Labelling
  • 5C Product Information
  • 5D Consumer Medicines Information
  • 5E Changes to Scheduling
Appendix 3: Guidelines on presentation aspects of OTC application
6B New substances Appendix 4: Guidelines on OTC application for new substances
9 MEC Guidelines Appendix 5: Guidelines on OTC application for specific products

Content of submissions

Submissions may address any, or all, of the proposed amendments to the ARGOM and other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the revised guideline.

What will happen

Submissions have been reviewed by the TGA and feedback on submissions is now available (see 'Summary of comments and TGA's response'). Changes will be made to the draft ARGOM documents as a result of consideration of the submissions and the final version will be published on the TGA website.

The selected chapters will be removed and reference made to the appendices in ARGOM, 2003 (see ARGOM 2003 updated to include reference to appendices). This document will remain as the guidance document until it can be fully replaced by the updated ARGOM, i.e. chapters such as Chapter 2, 3, 7, 8, 10 and 11 will remain in effect until such time it is replaced.


All submissions will be placed on the TGA's website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

More information

The TGA invited comments on the draft document from the following organisations:

  • ACCORD Australasia Limited
  • Australian Self-Medication Industry Inc. (ASMI)
  • Complementary Healthcare Council of Australia (CHC)
  • Consumers' Health Forum (CHF)
  • Generic Medicines industry Association (GMiA) of Australia
  • Medicines Australia (MA)

Stakeholders were able to forward comments to one of those organisations for incorporation into its response or to send comments directly to the TGA.