Minor variations to prescription medicines: Process guidance

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Version 2.0, December 2017

4 December 2017

Introduction

This guidance describes how to make minor variations to existing entries for prescription medicines in the Australian Register of Therapeutic Goods (ARTG).

General requirements

This guidance is split into sections:

See also

Separate guidance that sets out the individual variation change types for prescription medicines:

Process

See also

Other types of variations

Information about other types of variations to prescription medicines that are not minor variations is outlined in the Prescription Medicines Registration Process guidance.

Contact the TGA

Any questions regarding minor variations to prescription medicines should be directed to AET.application.entry.team@health.gov.au.

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