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Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012)

Version 1.4

9 November 2012

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1. Introduction

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

Selected chapters have been removed and replaced with references to the 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.

These guidelines describe the information to be supplied with applications for registration or variation of OTC medicines. These are medicines which are available without a prescription but not 'complementary medicines'. 'OTC medicine' and 'complementary medicines' are defined in the Therapeutic Goods Regulations 1990.

The object of the guidelines is to assist sponsors to submit applications which will be evaluated in the minimum possible time and be successful.

While the guidelines reflect the views of the TGA and its evaluation committees at the time of publication, there may be occasions where a departure from the guidelines is warranted. If you believe this to be the case, a justification for the departure should be submitted with the application. You may wish to contact staff of the OTC Medicines Section for advice in such instances.

The guidelines contain many references to legislation. However, these references, although accurate at the time of publication, are not intended to be comprehensive. It is the sponsor's responsibility to ensure that current regulatory requirements are fully met.

It is possible for some products containing 'new' substances (ie. those not contained in a product currently included in the Australian Register of Therapeutic Goods for supply in Australia) to be evaluated as OTC medicines. Provisional approval of a substance which is not, as yet, included in a product is also possible. Details of provisions for the approval of substances, as opposed to products, are given in Chapter 6B.

Except where otherwise indicated, these guidelines apply to products rather than substances.

The guidelines are available on the TGA website or in hard copy from the TGA Publications Office. Each chapter is separately numbered to facilitate future additions and amendments.

The TGA would welcome comments or suggestions and these should be directed to:

The Director
Non-prescription Medicines Branch
Therapeutic Goods Administration
PO Box 100

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