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Sep 05, 2023 656 likes •784 views

Updating medicine ingredient names International harmonisation of ingredient names Jola Samoc Project Manager Therapeutic Goods Administration IHIN@tga.gov.au ARCS webinar 10 June 2016 Overview Ingredient terminology What are the

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Updating medicine ingredient names

International harmonisation of ingredient names

Jola Samoc Project Manager Therapeutic Goods Administration IHIN@tga.gov.au ARCS webinar 10 June 2016

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Overview

Ingredient terminology
What are the changes?
Transition period

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Ingredient terminology

Australian Approved Names vs ingredient names used internationally

The World Health Organization’s International Nonproprietary Names (INN) are the gold standard for medicine ingredient names

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What are the changes?

Some changes are minor Spelling

Amoxycillin amoxicillin

Spacing

cyanocobalamin(57Co) cyanocobalamin (57Co)

Hydration state

carbidopa anhydrous carbidopa

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What are the changes?

Some changes are more significant  Dual labelling

lignocaine lidocaine (lignocaine) amethocaine tetracaine (amethocaine) colaspase asparaginase (colaspase)

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Adrenaline and noradrenaline

INNs: Epinephrine and norepinephrine Adrenaline and noradrenaline continue to be the names used in Australia. In addition to the approved ingredient name, the INN will also be required on:

Medicine labels
Product information
Consumer Medicine Information

This is consistent with the approach taken in the UK

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Transition period

Names within ARTG entries Updated by TGA Existing products Changes to labels and documents where an AAN is required New products Must use new AANs on labels and documents where an AAN is required Trade names Can update voluntarily Completed April 2016 Transition until April 2020 Dual labelling until April 2023 From time of registration/listing No fee until April 2020

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Informing health professionals and consumers

TGA working with

Industry representatives
Health professional groups
Medication software vendors

Key issue Timing of label changes

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Further information

TGA website

Full list of name changes
Information for sponsors
Information on adrenaline and

noradrenaline changes

Printable information materials

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Discussion and questions

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