Australian regulatory guidelines for OTC medicines (ARGOM)

30 November 2011

Review of the Australian Regulatory Guidelines for Over-The-Counter Medicines

The current Australian Regulatory Guidelines for Over-the-counter Medicines (ARGOM), published in 2003 is currently being reviewed and updated by the TGA.

The ARGOM have been substantially revised, updated and expanded by a working group composed of representatives from the Therapeutic Goods Administration (TGA), and the Australian pharmaceutical and cosmetics industry associations.

The following selected chapters of ARGOM have been re-formatted as appendices and released for consultation in November 2011:

The documents being released for consultation have been chosen on the basis that they are intended to provide sponsors with clear guidance on the data requirements for submitting effective OTC medicine applications to the TGA.

Following consultation, the selected chapters will be removed and reference be 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.

ARGOM

These Guidelines describe the information to be supplied with an application for registration of OTC (over-the-counter) medicines in the Australian Register of Therapeutic Goods (ARTG). These medicines will be subject to evaluation by the Therapeutic Goods Administration, in accordance with Section 25 of the Therapeutic Goods Act 1989.

This information will enable the determination of the application for registration and, accordingly, the Guidelines are approved for the purposes of subsection 23(2) of the Therapeutic Goods Act 1989 with effect from 1 July 2003.

The Guidelines also give guidance on the information required to be submitted for consideration of applications to vary information about therapeutic goods included in the Register, which are made under subsection 9D(1), (2) or (3) of the Therapeutic Goods Act 1989.

• Australian regulatory guidelines for OTC medicines (pdf,1.01Mb)*
• Australian regulatory guidelines for OTC medicines (Microsoft Word,4.04Mb)*

Amendment to Chapter 5C

Chapter 5C of the ARGOM has been updated in May 2011 in response to 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.

ARGOM amendment schedule

Changes since 1 July 2003

Previous versions are available from: ARGOM (archived)

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