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:
This consultation paper outlines considerations for the end of dual labelling and a proposal to transition labels in a certain time frame, to ensure consistent and timely changes occur across all products containing specific ingredients.
IHIN - Dual labelling transition to sole medicine ingredient names - Consultation paper
The 3-year time frame for requiring dual labelled ingredient names was an estimation of how long it would take health professionals and consumers to become familiar with the new ingredient names. This time frame could not have predicted the impact of a pandemic on the health systems and medicine supply chains.
The original plan for medicine sponsors to voluntarily change labels and PI/CMI documents to remove the old ingredient name at the end of the dual labelling period has the risk of being a drawn-out and inconsistent process. It could mean, for example, in 10 years, there may be different products with the same active ingredient still expressing the active ingredient differently.
We are seeking your input on whether all dual labelled ingredient names can transition to sole names and, if so, how the transition should occur.
We are seeking feedback to make sure:
We will consider all feedback received in response to this consultation before deciding on the approach to all the dual labelled ingredient names. We will inform stakeholders if there are any changes to the dual labelling period for any ingredient names or to the transition arrangements.
Share
Share on Twitter Share on Facebook