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

Closed 19 Dec 2022

Opened 7 Nov 2022

Contact

Scientific Operations Management Section

TGA.Scientific@health.gov.au

Feedback updated 4 May 2023

We asked

We asked for feedback on:

  • whether health professionals, consumers and health systems are ready for dual labelling (displaying both the old and new ingredient name on medicine labels and related documents) to end for all affected ingredient names
  • 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).

You said

We received 36 submissions in response to this consultation. 23 of the responses included permission for publication. Respondents provided a range of opinions about the end of dual labelling with many supporting a transition period and for some ingredient names to remain dual labelled for longer. We appreciate all the valuable feedback we received.

We did

We considered all feedback received before deciding on changes to the dual labelling transition to sole medicine ingredient names.

Changes to the dual labelling period for some dual labelled ingredient names

In response to the feedback we:

  • Extended the dual labelling period for 2 years (until 30 April 2025) for the following ingredient names to give health professionals more time to become familiar with these names:
    • dosulepin (dothiepin) hydrochloride
    • hydroxycarbamide (hydroxyurea)
    • tetracaine (amethocaine)
    • tetracaine (amethocaine) hydrochloride
    • trihexyphenidyl (benzhexol) hydrochloride.
  • Are not changing some dual labelled names to sole names. Labels of medicines supplied in Australia and included in the Australian Register of Therapeutic Goods (ARTG) must continue to display both the old and new ingredient name for the following:
    • alimemazine (trimeprazine) tartrate
    • mercaptamine (cysteamine)
    • mercaptamine (cysteamine) bitartrate
    • mercaptamine (cysteamine) hydrochloride
    • Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain).
  • Are ending the dual labelling period for most dual labelled names (those not listed above) on 30 April 2023 as planned.

New transition periods to update medicine labels to sole names

We implemented two separate 3-year transition periods for medicine sponsors to update medicine labels to reflect sole names, depending on when names are suitable for transition. We will encourage medicine sponsors to update PI and CMI documents to reflect sole names to align with updated labels during the transition periods.

  • The transition period for most dual labelled ingredients will start 1 May 2023, ending 30 April 2026. Affected medicines released for supply from 1 May 2026 must reflect sole names.
  • The transition period for ingredients subject to an extended dual labelling period will start 1 May 2025, ending 30 April 2028. Affected medicines released for supply from 1 May 2028 must reflect sole names.

The transition periods are included in the standards for medicine labels (Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines) via the Therapeutic Goods Legislation Amendment (Standards for Labels—International Harmonisation of Ingredient Names) Order 2023.

More information on changes to medicine labels from 1 May 2023

Changes to medicine labels take time and appear gradually as new stock is distributed, and existing stock is sold, to support the medicine’s availability in the community. More information about dual labelling and transition periods is available on the TGA website, see: 

Published responses

View submitted responses where consent has been given to publish the response.

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.

What happens next

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. 

Audiences

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Interests

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