Minor variations to prescription medicines
29 June 2017
The new electronic form for minor variations to prescription medicines will be available for clients through TGA Business Services from mid July 2017.
Guidance
Process
- Minor variations to prescription medicines: Process guidance
How to make minor variations to existing ARTG entries for prescription medicines
Chemical entities
- Minor variations to prescription medicines: Appendix 1: Variation change types - chemical entities
Outlines types of minor variations and changes that can be made to chemically derived (non-biological) prescription medicines currently on the ARTG
Biological medicines
- Minor variations to prescription medicines: Appendix 2: Variation change types - biological medicines
Outlines types of minor variations and changes that can be made to biological medicines currently on the ARTG
Forms
- Minor variations to registered prescription medicines: chemical entities and biological medicines
For making an application for a variation to registered prescription medicines: chemical entities and biological medicines