Updating medicine ingredient names International harmonisation of - PowerPoint PPT Presentation

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 changes? • Transition period Updating medicine ingredient names 1

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 Updating medicine ingredient names 2

What are the changes? Some changes are minor Spelling Spacing Hydration state Amox y cillin cyanocobalamin(57Co) carbidopa anhydrous cyanocobalamin (57Co) amox i cillin carbidopa Updating medicine ingredient names 3

What are the changes? Some changes are more significant  Dual labelling colaspase amethocaine lignocaine asparaginase tetracaine lidocaine (lignocaine) (colaspase) (amethocaine) Updating medicine ingredient names 4

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 This is consistent with the • Consumer Medicine Information approach taken in the UK Updating medicine ingredient names 5

Transition period Names within ARTG entries Completed April 2016 Updated by TGA Existing products Transition until April 2020 Changes to labels and documents where an Dual labelling until April 2023 AAN is required New products From time of Must use new AANs on labels and documents registration/listing where an AAN is required Trade names No fee until April 2020 Can update voluntarily Updating medicine ingredient names 6

Informing health professionals and consumers TGA working with • Industry representatives • Health professional groups • Medication software vendors Key issue Timing of label changes Updating medicine ingredient names 7

Further information TGA website • Full list of name changes • Information for sponsors • Information on adrenaline and noradrenaline changes • Printable information materials Updating medicine ingredient names 8

Discussion and questions Updating medicine ingredient names 9