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ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

15 April 2013

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Introduction

This interim guideline on changes to OTC medicines is based largely on ARGOM's Changes to OTC medicines (version 1.3 published October 2012). It has been updated to accommodate the new process for the pre-market evaluation of OTC medicines in Australia. The guideline will be updated and revised as needed throughout the staged implementation of the new process.

Where the sponsor of a registered OTC medicine wishes to make a change to the product, it is a condition of registration (under Section 28 of the Therapeutic Goods Act 1989 (the 'Act')) that, with limited exceptions, the change(s) requires prior TGA approval.

The 'Changes Table' provides guidance on the types of application required when a sponsor wishes to change the details of their registered OTC medicine. With the exception of changes requiring a 'new' application, the selection of a 'change code' will be linked to an application level - C1, C2, C3, or C4. This will determine the level of the application.

Where more than one change type is being proposed within a single application, the application level is determined by the highest application level (with C1 being the lowest level and C4 the highest).

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