TGA NEWS: Variations to prescription medicines - excluding variations requiring the evaluation of clinical or bioequivalence data

From: www.tga.gov.au

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.