The TGA conducted a review of medicine labelling requirements to address identified consumer health risks from issues like inadequate labelling contributing to medication errors. Consultation was conducted from 2011-2014 with stakeholders. The draft Therapeutic Goods Order 79 and Guideline for labelling of medicines propose changes like standardized formatting of active ingredients and medicine information panels. A Regulatory Impact Statement analyses the costs and benefits of options like introducing the new order or maintaining current guidance only. Feedback will be reviewed before the new rules are finalized.

1. TGA Medicine Labelling Review
Dr Lisa Studdert
Group Head, Market Authorisation Group, TGA
ARCS Scientific Congress 2014
11 September 2014

2. Objective of the review
• Develop and implement a revised labelling order (TGO 79) to address
identified consumer health risks resulting from medicine labelling issues
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3. (recent) History
• May 2011: national roundtable on safer naming and labelling of medicines
– Conducted with Australian Commission for Safety and Quality in Health Care
– Reason - evidence from Australia and overseas that inadequate labelling contributes to medication errors
and patient harm
– Aim – to develop a coordinated approach to improving medicines labelling in Australia by agreement and
coordination amongst key stakeholders.
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4. (recent) history cont’d
• July 2011
– TGA commenced a review of labelling requirements
• October 2011
– meeting with stakeholders to discuss consumer health risks
• May 2012
– consultation paper released; 110 submissions received from industry, healthcare professionals and
consumer groups (published on TGA website Nov 2012)
• February 2013
– meeting with stakeholders (industry, consumers, health professionals and government representatives):
labelling options discussed
• July 2013
– meeting with industry groups to discuss first (new) draft of TGO 79
• August 2013 & June 2014
– Therapeutic Goods Committee consulted on draft TGO 79.
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5. (older) History
• Based on a draft TGO 79 – consulted in 2008
• Amendments are from the current review as well as those previously consulted and agreed on from 2008
• + Editorial amendments
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6. August 2014: docs released for consultation
1. Draft Therapeutic Goods Order (TGO) No 79
2. Regulation Impact Statement (RIS): General requirements for labels for medicines
3. Guideline for the labelling of medicines
4. Comparison of TGO 79 with TGO 69
 Consultation period: 6 weeks – closes 7 October, 2014
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7. Why new medicine labelling order?
• TGO 69 is 13 years old - not kept pace with developments in EU, US, NZ which address ageing
populations and consumer education and expectations
• Develop and introduce new TGO in way that is feasible for industry to implement
• Proposing solutions that address consumer safety risks
– information about active ingredient(s) not always easy to find
– lack of a standardised format for information included on medicine labels
– dispensing stickers that cover important information
– information provided on blister strips, small containers and pack inserts confusing and not easy to
identify/read
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8. Draft TGO 79 - main proposed changes (1)
ACTIVE INGREDIENT (AI) – name and quantity
• Registered medicines – no smaller than equivalent of 15 point Arial (~ 4 mm) in any sans serif font
• Listed medicines – if ≥4 AIs – name of every AI may appear on side panel/label or rear panel/label (min size);
minimum text size 6 point Arial (1.5 mm)
• Small containers (not injections) – AI text size 8 point Arial (~ 2 mm)
• Very small containers (not injections) – name of medicine (trade name) 6 point Arial (1.5 mm)
• Minimum size: reference to text size instead of letter height
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9. Draft TGO 79 - main proposed changes (2)
• Name of medicine and AI must appear:
– As a cohesive unit
– AI immediately below name of medicine – each on a separate line
– Not separated by any text or graphics
– All required main label text orientated in same direction
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10. TGO 79 – main proposed changes (3)
• Prescription medicines only
– Minimum space of 70 x 30 mm for dispensing label (where primary pack size permits)
– Machine readable code
• Registered medicines requiring a Medicine Information Panel
– Black text with white background
– Standardised headings: ingredients, uses, warnings, directions for use, other info
– Left justified
– Headings highlighted by use of bold fonts, shading, box-borders, colour or other
– Medicine panel can be continued elsewhere on the label if not sufficient room
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11. Draft TGO 79 – main proposed changes (4)
INFORMATION ON LABEL - similar to TGO 69
• Minimum text size 6 point Arial
– Clearly visible and not obscured
– English
– Durable and legible characters
– *Be in a colour or colours contrasting strongly with the background
– Metric units
* Denotes change
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12. TGO 79 – main proposed changes (5)
• Transdermal patches
– Patch on the skin identified by a code, or the name of the medicine (strength if more than one), or name of
AI and how much release in a given time
• Blister strips
– Name of the medicine, AI, strength, at least once every two dosage units (TGO 69 only applied to those
which can be readily detached)
• Change of name and contact details of the sponsor
– Now within12 months
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13. Major changes from first draft TGO 79
• Naming of medicines – not in the Labelling Order
• LASA names and look-alike packaging will be addressed in Guideline
• “Due prominence” replaced with mandated text size requirements
– e.g. active ingredient, text size not less than the equivalent of 15 point Arial in any sans serif font
• Expiry date – no change from TGO 69 in relation to a product; means the date (month and year) after which
the product should not be used
• Three transition period options outlined in the RIS
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14. Regulatory Impact Statement (RIS)
Must answer 7 questions:
1. What is the problem you are trying to solve?
2. Why is government action needed?
3. What policy options are you considering?
4. What is the likely net benefit of each option?
5. Who will you consult about these options and how will you consult them?
6. What is the best option from those you have considered?
7. How will you implement and evaluate your chosen option?
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15. RIS - options
• Option 1 - no change
• Option 2 - Update the guidance on best practice for medicines labelling
– could include labelling elements described in Option 3 such as the recommendation that the minimum text
size be increased from the prescribed minimum in TGO 69 to 15 point Arial and that a transdermal patch,
when affixed to the skin, be labelled with the name of the medicine.
• Option 3 - Introduction of TGO 79 for labelling of medicines
– Option 3a - 2 year transition period
– Option 3b - 3 year transition period
– Option 3c - 4 year transition period
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16. RIS – costings, Option 1 (no change)
• Estimated current cost to business to comply with current arrangements = $14.6 million per annum
Assumptions include:
• 30% of 14980 variations are for labelling changes (=4495)
• Labour cost to change a label - 20 hours @$42/hour
• Pre-production costs:
– ‘medium’ level label change, including a number of changes to existing text and adding new text requiring
the logo to be moved around (e.g. artwork, redesign) = $1937 per product
– costs for a minor label change to a second or subsequent product in a product range (e.g. artwork,
redesign) = $1280 per product
– Production costs for a medium label change (described above) for a single product (e.g. new plate(s))
=$1290
– Production costs for a minor label change to a single product (e.g. new plate(s)) = $900
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17. RIS – costings, Option 2 (best practice guidance)
Assumptions:
• Most of the application to vary entry would be part of normal business
• Post production costs not counted as businesses would have incurred this cost in any case.
• No additional direct costs as any fee costs attached to other business decisions.
Issues:
• Compliance with Guidelines
• Inconsistency
• Consumer confusion
• Risk to consumer safety
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18. RIS – costings, Option 3 (TGO 79)
Assumptions:
• Currently marketed products change their labels as a matter of normal business, on average, every 2.9 years
• Costs/label – as per Option 1
• 6% discount rate (per annum) has been applied to products that would need to change labels earlier than
would be required as part of ordinary business.
Cost to industry (>business as usual) per annum over 10 years:
• 2 year: $3.0 million
• 3 years: $1.7 million
• 4 years: $0.7 million
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19. Comparing TGO 79 with TGO 69 - overview
• Changing label requirements
– reasons, transition period, terms used
• Changes which will reduce red tape
• Changes to label content
– by medicine type, for specific ingredients and route of administration, particular packaging
• Changes to label formatting
– identification of AI, direction of text, font size
• Other changes to label
– Opening effect on readability, intermediate packaging, delivery devices, durable information
• Unchanged requirements
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20. Guideline for the labelling of medicines - overview
• The name of a medicine
• How to quantify active ingredients
• Use of colour
• Different types of medicines
• Registered non-prescription medicines – medicine information panel
• Medicines applied using specific routes – skin/membrane, ophthalmic, injection
• Medicines with specific ingredients
• Different types of packaging
• Optional information – braille, international labels, QR codes, web address
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21. Post consultation
• Review and revise documents based on consultation submissions
• Submit revised RIS to OBPR – final assessment and check of compliance
• Discussion with Government re. final RIS and preferred option
• National Manager sign off (if new labelling order)
– Lodgement on FRILI
– Implementation date from early 2015
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