TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

TGA presentation: Medical Affairs Interest Area Meeting (Webinar), 10 June 2016

Presentation: Updating medicine ingredient names: International harmonisation of ingredient names

28 June 2016

Disclaimer

These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Jolanta Samoc, Project Manager, Therapeutic Goods Administration
  • Presented at: Medical Affairs Interest Area Meeting (Webinar)
  • Presentation date: 10 June 2016
  • Presentation summary: From April 2016, TGA will be updating some medicine ingredient names used in Australia to align with names used internationally

Transcript

Updating medicine ingredient names: International harmonisation of ingredient names

Jola Samoc
Project Manager
Therapeutic Goods Administration

ARCS webinar, 10 June 2016

Slide 1 - Overview

  • Ingredient terminology
  • What are the changes?
  • Transition period

Slide 2 - 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

Slide 3 - What are the changes

Some changes are minor

  • Spelling: amoxycillin → amoxicillin
  • Spacing: cyanocobalamin(57Co) → cyanocobalamin (57Co)
  • Hydration state: carbidopa anhydrous → carbidopa

Slide 4 - What are the changes?

Some changes are more significant → Dual labelling

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

Slide 5 - 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

Slide 6 - Transition period

Names within ARTG entries

Updated by TGA

  • Completed April 2016

Existing products

Changes to labels and documents where an AAN is required

  • Transition until April 2020
  • Dual labelling until April 2023

New products

Must use new AANs on labels and documents where an AAN is required

  • From time of registration/listing

Trade names

Can update voluntarily

  • No fee until April 2020

Slide 7 - Informing health professionals and consumers

TGA working with

  • Industry representatives
  • Health professional groups
  • Medication software vendors

Key issue

Timing of label changes

Slide 8 - Further information

TGA website

  • Full list of name changes
  • Information for sponsors
  • Information on adrenaline and noradrenaline changes
  • Printable information materials

Slide 9 - Discussion and questions

Keep an eye on safety as medicine ingredient names change

Print version

How to access a pdf document