Guidance

Process

• Variations to prescription medicines - excluding variations requiring the evaluation of clinical or bioequivalence data: Process guidance
  How to make variations to existing ARTG entries for prescription medicines

Chemical entities

• Variations to prescription medicines - excluding variations requiring the evaluation of clinical or bioequivalence data; Appendix 1: Variation types - chemical entities
  Outlines types of variations and changes that can be made to chemically derived (non-biological) prescription medicines currently on the ARTG

Biological medicines

• Variations to prescription medicines; Appendix 2: Variation types - biological medicines
  Outlines types of variations and changes that can be made to biological medicines currently on the ARTG

Forms

• Making variations to registered prescription medicines: The Variation e-form is available through the TBS portal.

Frequently Asked Questions

• Answers to some frequently asked questions on using the prescription medicines Variation e-form.