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Regulation impact statement: International harmonisation of ingredient names
Version 1, November 2015
The main objective of the proposal is to provide clarity and consistency in naming (as far as possible) to support the quality use of medicines. The proposal also aims to minimise administrative costs for industry, thereby supporting the commercial viability of supplying medicines to Australian consumers.
This RIS outlines the following options to achieve these objectives:
- Option 1 proposes no change (status quo).
- Option 2 proposes to change 478 ingredient names to their harmonised nomenclature.
- Option 3 reduces the full proposal by applying status quo to:
- 3a - Metal-containing ingredient names
- 3b - Sunscreen active ingredient names
- 3c - The spelling of some excipient names
- 3d - Macrogol excipient names
- Option 4 proposes to further reduce name changes to only those where there is direct harmonisation with a reference, plus those considered of high clinical significance.
- Option 5 allows a voluntary approach to the proposed name changes (or a subset thereof).
The benefits of improved global harmonisation and contribution to the quality use of medicines for Australians will not be realised under Options 1 and 5. In considering the alternative mandatory adoption proposals (Options 2, 3 and 4), the most cost effective approach is sought to minimise implementation problems that may offset these benefits.
Option 3 is the preferred option. This option would increase the alignment of Australian ingredient names with widely accepted international terminology by harmonising a large proportion of the identified inconsistencies. At the same time, harmonisation will not be imposed when the regulatory costs would potentially outweigh the benefits. The net regulatory cost of this Option will be offset by other gains, such reduced risk of incorrect use of medicines and clarity for patients and healthcare providers. This option will also result in a small reduction in barriers to trade for individual companies, however it is not expected to have a noticeable effect on the market overall.
A four year transition period for these changes is proposed. This transition period would minimise most of the costs of the ingredient name changes as it fits well with business as usual label changes identified by industry during consultation.
To mitigate the risks to consumers, 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.
Due to the qualitative gains from harmonisation, this option is expected to result in an overall net benefit to consumers, healthcare professionals and industry once the name changes are embedded in Australian nomenclature.