AUS/147
WTO/TBT
AU Australie
  • 11 - Technologies de la santé
2023-01-09
2022-11-11

Medicines

International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names; (21 page(s), in English)

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 2022 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).