International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names

Closes 19 Dec 2022

Opened 7 Nov 2022

Overview

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 specific time frame (for names suitable for transition).

Consultation paper

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

Making a submission

  1. Read the consultation paper (see link above).
  2. Go to the online consultation questions, complete and submit your response (see 'Give us your views' below).

Why your views matter

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:

  • 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.

Give us your views

Audiences

  • Anyone from any background

Interests

  • e-Health
  • Legislation
  • Regulatory policy
  • Prescription drugs
  • Non-prescription medicines