Guidance 2: Fees and charges for prescription medicines

Introduction

This guidance:

• outlines the types of fees for services that apply to the registration of prescription medicines, and the variation of existing registrations.
• provides an overview of the various types of applications to do with prescription medicines.
• explains when payments are required for the various types of applications to register prescription medicines or to vary information on the Australian Register of Therapeutic Goods (ARTG) about prescription medicines.
• describes the provisions in the Therapeutic Goods Regulations 1990 (the Regulations) for waiving or reducing fees and charges, and provides information about refunds.
• explains what annual charges are.

Contents

Version history