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Regulation impact statement: International harmonisation of ingredient names
Version 1, November 2015
4. Options to achieve objectives
This RIS considers the following options for the list of 478 active and excipient ingredient names proposed for harmonisation:
Option 1: Status quo - No changes would be made to ingredient names.
Option 2: Mandatory adoption of harmonisation with international protocols - the full proposal - Adopt all the proposed name changes (478 ingredient names changed). The old ingredient names would be removed from the Ingredients Table and sponsors would only be able to use the new ingredient names.
Option 3: Mandatory adoption - a reduced proposal - This option proposes to reduce the full list of name changes, based on issues raised during consultation. This option focusses on removing ingredient name changes that have not been adopted consistently in the international market:
- Maintain status quo for metal containing ingredients - No Latin-to-English name changes would be made to metal-containing ingredients.
- Maintain status quo for sunscreen ingredients - No changes would be made to names that are used for active ingredients in current TGA-regulated sunscreens.
- Maintain status quo for some excipient ingredients - No changes would be made to some excipients where the source reference did not apply this terminology.
- Maintain status quo for macrogol excipient ingredients - No changes would be made to macrogol ingredients only used as excipients.
Under this option, 336 ingredient names would change.
Option 4: Mandatory adoption - only those changes based on direct harmonisation of INNs or references plus changes of high clinical significance - This option proposes to further reduce the full list by only implementing name changes where the replacement name has an international reference or an INN which has not been modified, plus a number specific ingredients identified as being of high clinical significance.
Under this option, 160 ingredient names would change.
Option 5: Voluntary name changes - New ingredient name entries would be created on the Ingredients Table and sponsors could voluntarily move to using the new names or continue to use the old ingredient name. Consequently, different products could use different ingredient names on their labels when they are actually referring to the same substance. This voluntary approach can be applied either to the full proposal (478 names) or to a reduced list.
A transition period would be needed for Options 2, 3 and 4. Two transition options are presented:
- Transition Option (i): proposes a three year transition period for changing ingredient names.
- Transition Option (ii): proposes a four year transition period for changing ingredient names.
For both transition options, medicines with ingredients identified as of ‘high clinical significance’ would be dual-labelled with both the old and new name for an additional three years. Following this period, sponsors could then start using the new ingredient name as the sole name.