G/TBT/N/AUS/147  
10 November  2022 
(22-8422) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  AUSTRALIA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Therapeutic Goods Administration, Department of Health and Aged Care  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Department of Foreign Affairs and Trade  
Email: tbt.enquiry@dfat.gov.au  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medicines  
5. Title, number of pages and language(s) of the notified document:  International 
harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine 
ingredient names ; (21 page(s), in English)  
6. Descriptio n of content:  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) .  
The TGA is conducting a public consultation between November and December 202 2 to 
seek 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).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The 3 -year time frame for requiring dual labelled ingredient names was an 
estimat ion 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 me dicine 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 G/TBT/N/AUS/147  
 
- 2 - 
 
  years, there may be di fferent products with the same active ingredient still expressing 
the active ingredient differently.  
 
The Therapeutic Goods Administration (TGA) is seeking input on whether all dual labelled 
ingredient names can transition to sole names and, if so, how the  transition should occur. 
The objectives are 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 ensur ing 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.  
Consumer information, labelling; Protection of human health or safety; 
Harmonization  
8. Relevant documents:   
The consultation paper is available at International harmonisation of ingredient names 
(IHIN) – Dual labelling transition to sole medicine ingredient names . This docum ent 
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.  
9. Proposed date of adoption:  The TGA  is seeking feedback on timeframes for a proposed 
transition period and the approach to the current dual labelling period as part of the 
consultation.  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
The consultation paper is available at https://consultations.tga.gov.au/medicines -
regulation -division/international -harmonisation -of-ingredient -names -ih 
https://consultations.tga.gov.au/medicines -regulation -division/international -
harmonisation -of-ingredient -names -ih/user_uploads/ihin ---dual-labelling -transition -to-
sole-ingredient -names ---consultation -paper ---november -2022.pdf