Opening date: 7 November 2022
Closing date: 19 December 2022
While the consultation is open you can make a submission at our TGA consultation hub.
We review the submissions carefully. After that the submissions and our decision will be available on the same page at the TGA consultation hub.
About this consultation
The Therapeutic Goods Administration (TGA) is seeking views on medicine ingredient names that must be displayed as both the old and new ingredient name ('dual labelled') on labels and Product Information (PI) and Consumer Medicine Information (CMI) documents until 30 April 2023 as part of International harmonisation of ingredient names (IHIN).
We are seeking feedback on:
- whether health professionals, consumers and health systems are ready for dual labelling to end for all ingredient names currently required to be dual labelled
- a proposal to transition medicine labels and PI/CMI documents to sole medicine ingredient names in a certain time frame (for names suitable for transition).
We are seeking your views to make sure:
- any sole medicine ingredient names on medicine labels after the end of the dual labelling period would not cause any confusion or potential medication errors
- a transition period would help in ensuring consistent and timely changes occur across all products containing specific ingredients and would give more clarity for health professionals and consumers than the original plan.
All recent TGA consultations can be found at the TGA consultation hub.