White Paper – How to list or register a medicine in Australia

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White Paper – How to list or register a medicine in Australia

Purpose

This White Paper on how to “How to list or register a medicine in Australia” is written to assist those interested in the process for approval to supply TGA regulated therapeutic products in Australia.

Audience

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

Overview

The white paper addresses:

  • Australia’s Regulatory System for Medicines including prescription, complementary and OTC products
  • 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 list or register a medicine in Australia” here.

View all White Papers available from PharmOut

You might also be interested in the following blogs:
White Paper – How to list or register a complementary medicine in Australia
White Paper – How to register a prescription medicine in Australia

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