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Presentation: Changes to medicine labels
TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016
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- Presented by: Jenny Burnett
- Presented at: ARCS Scientific Congress Canberra
- Presentation date: 10-11 August 2016
- Presentation summary: This presentation discusses the recent changes to medicines labelling in Australia including the history and consultation as well as the changes and features brought in with Therapeutic Goods Order No. 79.
Changes to medicine labels
Director, Scientific Operations Management Section
Scientific Evaluation Branch
Medicines Regulation Division, TGA
ARCS Scientific Congress Canberra 2016, 10-11 August 2016
Slide 1 - Overview
- Why update the TGO 69?
- History and consultation
- Labelling Orders - changes and features
Slide 2 - Updating the labelling Order
Responding to internal and external stakeholder needs:
- Medicine labels and QUM
- Addressing technical inadequacies
- Clearer labelling requirements
- Need for international alignment
Slide 3 - Reform outcomes
Consistent location of important health information
Ensure important information is not obscured
Improve safety and quality use of medicines for consumers
Reduce medication errors
Slide 4 - History and consultation
2001 - Re-drafting of TGO 69 commenced
2012 - Public consultation on labelling and packaging
2013 - Review of Evidence regarding key issues about labelling and packaging
Post ANZTPA - removal of 'packaging' requirements from scope of review
Post 2014 public consultation, TGO 79 was split into two separate orders: TGO 91 and 92.
Stakeholders who provided submissions in 2014 public consultation were invited to comment.
Slide 5 - Two labelling Orders
TGO 91 - For prescription and related medicines
TGO 92 - For non-prescription medicines
Slide 6 - Key features and changes to labelling requirements
Slide 7 - 4 year transition period
Slide 8 - Prominence of active ingredient
- Larger and clearer text
- Consistent location of information
- Easier identification of active ingredient name and quantity information
Slide 9 - Schedule 1 - Declarable substances
- The list has grown to address consumer needs
- Tree nuts
- Some entries have been modified
- Gluten now has a 20ppm cut off
- Prescription Medicines can use a label statement referring consumers to CMI for declarable substances
Slide 10 - Key prescription medicine changes
- Medicine name to be on at least 3 sides of the carton
- Mandatory 70x30mm space for dispensing labels
- Small containers now 25mL capacity
- Microgram and microlitre must be spelled out in full (no µ allowed except small and very small containers)
Slide 11 - Prescription medicine label
Slide 12 - Key non-prescription medicine changes
- Display of Critical Health Information (CHI) for AUST R medicines
- Use of 'active moiety' on main label instead of full ingredient name
- Changes to container sizes
- Small containers now 25mL capacity
- New medium container size up to 60mL
Slide 13 - Non-prescription OTC medicine label
Slide 14 - Non-prescription listed medicine label
Slide 15 - Questions?
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