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Australian regulatory guidelines for OTC medicines (ARGOM)

15 April 2013

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.

ARGOM guidelines

These guidelines should be seen as interim and will be modified and updated as required prior to and during the 12 month period of phased implementation. Representatives of industry, health professionals and consumers are encouraged to review these documents over this period, and can submit feedback to OTCBPR@tga.gov.au.

ARGOM appendices

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Web page last updated: Wednesday, 17 April 2013

URL: http://www.tga.gov.au/industry/otc-argom.htm