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Applying for inclusion of a Class 1 biological in the ARTG

Australian Regulatory Guidelines for Biologicals (ARGB)

6 January 2020

This page is to help you navigate through the stages of preparing and submitting an application for inclusion of a Class 1 biological on the Australian Register of Therapeutic Goods (ARTG).

This document should be read in conjunction with the following information:

If you are new to supplying a therapeutic good, you may find our overview of applying for market authorisation helpful.

To supply a class 1 biological

To supply a Class 1 biological you need to:

  1. Ensure your biological is listed in Schedule 16 of the Therapeutic Goods Regulations 1990
    1. Check the current Schedule 16 instrument lists your good as a Class 1 biological
      1. If your biological is not listed then contact us for further advice
      2. If your biological is listed then continue to step 2.
  2. Include your biological on the ARTG
    1. Prepare your documentation for inclusion of a Class 1 biological in the ARTG.
    2. Follow the biologicals application form - a step-by-step guide to submit the application form with your documentation.

Documentation for inclusion of a Class 1 biological in the ARTG

To be included on the ARTG for supply in Australia, sponsors of Class 1 biologicals:

  • must submit a statement of compliance
  • do not need to submit additional documentation
  • do not need GMP licences or clearances for biological manufacturers.

We will review the statement of compliance.

Statement of compliance

Sponsors who are applying to have a Class 1 biological included on the ARTG must submit written certification confirming that the biological:

Version history
Version Description of change Author Effective date
V1.0 Original publication, using material from the previous ARGB and incorporating recent legislative changes.

Biological Science Section

Regulatory Guidance Team

July 2018