White Paper – How to register a prescription medicine in Australia

How to register a prescription medicine in Australia

Purpose

This white paper on “how to register a prescription medicine in Australia” provides an outline of the legal and regulatory requirements and processes for obtaining approval to supply prescription medicines in Australia. It outlines the steps to fulfil the requirements for manufacture and supply of the products and provides practical tips on which path to follow, the associated TGA departments, timelines and costs involved.

Audience

This White Paper is written to assist anyone interested in the planning and execution of regulatory activities to support supply of prescription products in Australia.

Overview

The white paper addresses:

  • Australia’s Regulatory System for Prescription Medicines
  • Key roles in Australia’s regulatory framework for medicines
  • Manufacturing requirements
  • TGA Application and registration process
  • Regulatory requirements after registration

You can download the whitepaper “How to register a prescription medicine in Australia” here.

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