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Regulation impact statement: International harmonisation of ingredient names
Version 1, November 2015
8. Implementation and review
During the transition period, TGA will collaborate with product sponsors to update ingredient names in:
- Business Services Ingredients Table
- ARTG entries
- medicine labels.
8.1 Business Services Ingredients Table
TGA proposes to update the Ingredients Table with the new names at the beginning of the transition period. TGA will include in each entry any previously used names as synonyms for the new ingredient name. Therefore searches of the Ingredients Table using an old name will retrieve the new name entry.
Where the new ingredient name already exists in the Table, the old name will be hidden on the public interface. For example, both 'colecalciferol' and 'cholecalciferol' are current entries: 'Cholecalciferol' will be hidden and 'colecalciferol' will be the only visible entry for this substance. For those ingredients that do not have a new harmonised name already available, a new entry will be created. The old name will then be hidden. Once the Ingredients Table is updated, sponsors would only be able to use the new harmonised names for entering new products onto the ARTG.
TGA will also ensure that these name changes flow onto other TGA Business Services systems (listed medicine validation rules, the Prescription Medicines Electronic Lodgement facility [PREMIER] etc.).
For dual-labelled ingredients, the name change process will be the same as for other ingredient name changes. At the end of the dual-labelling period, TGA will change the dual-labelled ingredients36 to their new name as the sole name. This will be done by changing the dual-labelled entry to its sole name in the Ingredients Table. Sponsors would be able to voluntarily change their ARTG entries to reflect the harmonised name as the sole name.
TGA will update affected ARTG entries in collaboration with sponsors. TGA will write to individual sponsors to notify them of this activity and of the need to assess their products for any associated changes to labelling or supporting product information. This letter will also include a return TGA form to acknowledge their cooperation with the updates.
TGA will also notify affected sponsors when the dual-labelling period has expired. At this time, affected ARTG entries will be automatically updated to the sole new name. No fee is associated with this change.
8.3 PI and CMI
If the PI or CMI specifies an ingredient name that has been harmonised, this documentation will need to be updated to reflect the new name. For variations to the ARTG requested under s. 9D of the Act - including 9D(1), 9D(2) and 9D(3) - approval of a change to the PI is made under s. 25AA(4).
No fees will be charged to change a PI and CMI, as long as the only change is that to the ingredient name for the purposes of this harmonisation activity. Sponsors could apply to change the ingredient name on PI/CMI documentation at the same time as they wish to make other changes to their product details using the usual variation processes. However, these combined applications would be subject to the usual TGA fees.
For dual-labelled ingredients, both the old and new name will need to be specified in the 'active ingredient' section of the PI/CMI, as well as any other section where the old name is included. At the end of the dual-labelling period, sponsors will be able to move to using the sole name on PIs and CMIs voluntarily.
8.4 Changes to legislative instruments
Several legislative instruments will be updated to reflect the new names, specifically:
- TGO No. 80 (Child-Resistant Packaging Requirements for Medicines) - e.g. 'frusemide' will change to 'furosemide'.
- Therapeutic Goods Regulations 1990, Schedule 2 and Schedule 4 - e.g. 'cholecalciferol' and 'alpha-tocopherol' will change to their new names.
- Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) - ingredients may change to their harmonised name or be included as synonyms in the index. Some of these changes have already been implemented through separate SUSMP processes.
The same regulatory requirements will continue to apply for these ingredients, regardless of which name is used in the legislative instrument.
8.5 Communication and education
A communication strategy will help raise awareness of the changes for healthcare professionals and consumers so that the correct medicine is prescribed and taken.
The UK underwent a similar ingredient name harmonisation process in 2003, at which time British Approved Names and names of ingredients in the BP were updated to reflect international naming policy. The following communication and education strategies were developed applying the lessons learnt from the UK process, as well as input from stakeholders during consultation.
In line with the TGA external communication and education framework 2013-201537, TGA will work closely with consumer and healthcare professional organisations to develop and disseminate information about the ingredient name changes. These organisations have existing resources and networks that extend beyond those currently available to TGA.
8.5.1 Targeted communication
TGA will work with the National Prescribing Service (NPS MedicineWise) and other consumer and healthcare professional organisations to develop communication and education strategies with a focus on:
- specific areas of practice (general practitioners, nurses, pharmacists) and
- specific types of ingredients (substances of high clinical significance, anaesthetics, ingredients used in common over-the-counter products).
A range of communication materials will be developed through different media. These will include articles in trade magazines, targeted mail-outs to sponsors and healthcare professionals, information pamphlets that healthcare professionals can pass on to consumers, and presentations at professional seminars or conferences. TGA will also investigate opportunities for updating practitioner training materials (such as reference texts - the Australian Medicines Handbook).
TGA will also create a dedicated page on the TGA website that will be a central source of information on the changes and contain a copy of useful communication and education materials. All communication materials will provide links back to this central webpage. This webpage will also include a searchable database of old and new active ingredient names. Consumers, healthcare professionals, industry and government would be able to check whether an ingredient name was changed.
8.5.2 Updating dispensing and prescribing software
TGA will work closely with NeHTA to implement ingredient name changes on prescribing and dispensing software. NeHTA currently adapts their terminology used in dispensing software from existing ARTG entries and TGA provides regular ARTG updates to ensure that their terminology is current. NeHTA moderates these changes, which can then flow onto prescribing and dispensing software that use NeHTA terminology.
The PBS has adopted the NeHTA medicines terminology. Any ingredient name changes that are taken up by NeHTA systems will be reflected in the PBS systems.
8.6 Monitoring and review
During the transition period, TGA will monitor a subset of ingredient name changes in PIs/CMIs and labels. TGA will also monitor queries from consumers, healthcare professionals and industry about the ingredient name changes. Specific monitoring attention will be given to ingredients of high clinical significance (those that have been dual-labelled).
TGA will review the success of the harmonisation activity by measuring the uptake of ingredient name changes and the number and type of stakeholder queries. This review will occur:
- At the end of the four year transition period and
- At the end of the dual-labelling period.
- Excluding adrenaline and noradrenaline entries.
- TGA external communication and education framework