Stability testing for prescription medicines

Introduction

This guidance applies to sponsors submitting applications to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG). It:

• identifies the European Union guidelines for stability testing that have been adopted by the TGA for testing the active substance and the drug product
• explains additional information that may be required to include in Module 3 of the Common Technical Document (CTD) to demonstrate stability of the medicines under Australian conditions.

The information requested in this guidance is to be included in the relevant CTD modules.

Contents

The guidance is divided into the following subsections:

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