November Management and Coordination Section … · Office of Scientific Evaluation Therapeutic Goods Administration PO Box ... division and a consumer healthcare ... BY GLAXOSMITHKLINE

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14 November 2014

TGA Medicine Labelling Consultation

Management and Coordination Section

Office of Scientific Evaluation

Therapeutic Goods Administration

PO Box 100 WO DEN ACT 2606

Email: [email protected]

Dear Sir/Madam,

Re: TGA Consultation on Medicines Labelling

GlaxoSmithKiine

82 Hughes Avenue Locked Bag 3 Ermington NSW 2115 Australia

Tel: +61 2 9684 0888 Fax: +61 2 9684 1018 www.gsk.com.au

GlaxoSmithKiine Consumer Healthcare {GSK Consumer Healthcare) makes the following submissions

in relation to the TGA Consultation on Medicines Labelling, including the following documents:

• The proposed options in the Regulation Impact Statement on the general labelling

requirements for medicines, • Draft Therapeutic Goods Order (TGO) No. 79 Standard for the labelling of medicines, • Comparison of TGO 79 with TGO 69, and • Guideline on medicines labelling.

GSK is sub-divided into a prescription division and a consumer healthcare division. The entire

company concurs on the overall merits and issues of the proposals raised within the consultation.

However, given the differences in how prescription and OTC medicines are regulated, labelled and

supplied to consumers each division has submitted its own response to this consultation. This

submission, therefore, focuses on the proposals and their implications as they relate to the OTC

sector of the market only.

Although the comments herein are restricted to the perspective of over-the-counter (OTC)

medicines, GSK Consumer Healthcare hopes that the data and discussion provided in this submission

will provide decisive information on the impact of the proposed regulatory changes to the labelling

of medicines in Australia. Where our analysis differs from the views presented in the draft

documents we have proposed alternative recommendations for the TGA to consider.

Due to its nature and content, certain sections of the document contain commercially sensitive

information. These sections have been marked within bold square parentheses[] for emphasis and

ease of reference and identification for red action. Full-size copies of the examples of labels have

been provided separately on a CD and should also be treated as commercially sensitive.

Should you require any additional information please do not hesitate to contact me.

GlaxoSmithKiinc Australia Pty Ltd ABN47100 162481

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TGA CONSULTATION ON MEDICINE LABELLING

CONSULTATION RESPONSE SUBMISSION PREPARED BY GLAXOSMITHKLINE CONSUMER HEALTHCARE

CONTENTS Executive Summary ................................................................................................................................ 4 1. Introduction ..................................................................................................................................... 9 2. Feedback on the draft TGO 79 ...................................................................................................... 10

2.1 Transition timeframes ........................................................................................................... 10

GSK Consumer Healthcare Recommendation ......................................................................10

2.2 General requirements: label presentation ............................................................................ 11

2.2.1 Text Size: The need for clarity around the terminology and enforceability of “text size equivalents” ............................................................................................11


2.3 Information to be included on the main label ...................................................................... 16

2.3.1 Minimise the impact on existing branding for OTC medicines ...................................16


2.3.2 Reduction in text size for active ingredients ...............................................................18

CASE EXAMPLE 1: ENO .............................................................................................. 19

CASE EXAMPLE 2: Panadol Cold & Flu ....................................................................... 19

CASE EXAMPLE 3: Panadol Extra ............................................................................... 21

CASE EXAMPLE 4: Panadol ........................................................................................ 22

CASE EXAMPLE 5: Medicines with a small primary pack .......................................... 22

2.3.3 Special consideration for OTC products containing four or more active ingredients ..............................................................................................23

CASE EXAMPLE 6: Panadol cold and Flu; Flu Strength Day & Night .......................... 24


2.4 Small and very small containers ............................................................................................ 25

2.4.1 Expansion of the definition of “small container” .......................................................25


2.5 Introduction of a Medicine Information Panel ..................................................................... 26

2.5.1 Registered OTC medicines with negligible risk ...........................................................27

2.5.2 Products in small (or intermediate-sized) containers ................................................27

CASE EXAMPLE 7: Medicines without a primary pack .............................................. 28

2.5.3 Products with a restricted surface area label size and no primary pack ....................28

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CASE EXAMPLE 8: Limited label space ...................................................................... 28

2.5.4 Unnecessary colour restrictions .................................................................................29

CASE EXAMPLE 9: Hydrozole ..................................................................................... 29

2.5.5 Proposed solution for issues relating to the Medicines Information Panel ...............30


3. Feedback on the regulation impact statement ............................................................................. 31

3.1 Process for changes ................................................................................................... 32

3.2 Lack of Trans-Tasman consultancy ............................................................................ 32

3.3 Cost of compliance with the new order .................................................................... 32

4. Summary and overview of opinion on recommendations ............................................................ 34

Transition timeframes ..........................................................................................................34

General requirements: label presentation ...........................................................................34

Information to be included on the main label .....................................................................35

Small and very small containers ...........................................................................................36

Medicine Information Panel .................................................................................................37

5. Reference materials ...................................................................................................................... 40

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EXECUTIVE SUMMARY

GlaxoSmithKline (GSK) is a global research-based pharmaceutical and healthcare company with a mission to improve the quality of human life by enabling people to do more, feel better and live longer.

GSK is sub-divided into a prescription division and a consumer healthcare division. GSK Consumer Healthcare manufactures and markets a wide range of over-the-counter (OTC) medicines that are sold in pharmacies and supermarkets.

OTC medicines are an essential, effective and convenient component of Australia’s healthcare system. The on-pack labeling is critical because it provides all of the information a consumer needs for self-selection of a medicine and for its safe and effective use.

GSK Consumer Healthcare welcomes viable initiatives to further support the safe and effective use of OTC medicines and agrees with the principles behind the proposed regulatory changes to medicine labelling. However, the specifics of some of the proposed changes when applied to OTC medicines have some unintended consequences and so warrant further discussion, clarification and resolution before TGO 79 is put into effect.

This submission highlights issues that may be encountered and then proposes action-oriented solutions to ensure that the intention of better facilitating the safe use of OTC medicines by consumers is met.

Transition timeframes

The currently proposed transition timeframe of 3 or 4 years will place considerable pressure on GSK Consumer Healthcare. The proposed timeframes do not account for:

the pre-work that has to be undertaken before revised labelling is submitted for approval implications as a result of merger and acquisition activity manufacturers who produce identical labels for use in multiple jurisdictions e.g. Australia and

New Zealand.

GSK Consumer Healthcare proposes an extended transition period for non-prescription medicines of 5 years.

Clarity around the terminology and enforceability of text size equivalents

The draft TGO 79 has changed the way in which font size is specified by attempting to adopt a new approach. This new approach applies a ‘text size equivalent’ to accommodate the height and width of letters. This new approach is not a measurement system.

The “typographic point,” is expressed in a non-standard unit which has no coherent relationship to standard measurements. In general, the "point size" of a font refers to the size of the x-height plus the ascender area size or the descender area size. Typefaces differ greatly such that there is no direct relationship between point size and visual size. The most important factor in terms of visual or comparative size is the font’s x-height.

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Although mm heights are used in current legislative instruments the potential for confusion has arisen because the wording is not always explicit regarding which aspect of the letter is being referred to. This confusion can be circumvented by being explicit about the use of x-heights.

GSK Consumer Healthcare proposes the use of mm x-height equivalents be incorporated into the documentation to facilitate the ability of regulatory staff to check adherence to the guidelines prior to making label submissions to the TGA.

Strategies to minimise the impact on existing branding for OTC medicines

The draft TGO 79 mandates that the name of the medicine must be presented in a continuous, uninterrupted manner and not be broken up by additional information, logos, background texts or graphics and that the name of the medicine and the active ingredients must be presented as a cohesive unit by placing the actives directly beneath the name of the medicine.

These proposals present multiple issues for the labelling of many OTC medicines that already contain graphic/typographical elements as part of their established branding.

GSK Consumer Healthcare proposes that provisions be made such that existing branding/trade-marketed devices in use on non-prescription products be permitted to be retained and sub-brand names, with their associated active ingredients and quantities, may sit in a different location to the proprietary name provided that the positioning and orientation of this information conforms to the provisions in TGO 79.

Accommodation of text size for active ingredients

The draft TGO 79 [section (9)(7)(a)] states that the name of the active ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed in a text size of not less that the equivalent of 15 point Arial in any sans serif font. This causes presentation issues for the labelling of many OTC medicines, particularly those with up to three active ingredients or those that have small or irregular label sizes. The large font size limits the ability of Sponsors to adequately display the required information without causing unintended confusion.

The draft TGO 79 [section (9)(8)(a) and (b)] is intended to accommodate the needs of products which contain four or more active ingredients. Following the details of this guidance it appears that nothing need be displayed on the main (front of pack) label. Not listing the names of the active ingredients on the front panel makes it harder for a consumer to determine what is in it.

GSK Consumer Healthcare proposes that provisions be made such that:

the active ingredient(s) and the quantity or proportion of active ingredient(s) may be displayed in a text size of not less that the equivalent of 10 point Arial in any sans serif font,

the active ingredient(s) and the quantity or proportion of active ingredient(s) may be displayed directly beneath the sub-brand names, and

where the full names of the active ingredients make it impossible to list them on the front panel, the short form names (minus quantity) may be listed with the full details provided on the back panel.

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Expansion of the definition of “small container”

The draft TGO 79 has made a number of provisions for small containers such that the labelling requirements of the container are less than they have been previously, provided that the primary pack is fully compliant. The draft TGO 79 also makes provision for injections with a nominal volume less than 100 mL but greater than 25 mL.

The current definition of a small container is based on nominal capacity and therefore only relates to products supplied in liquid form in small amounts. This definition excludes certain other packaging formats that are limited by their size and forces them to conform to the revised requirements for normal sized products, creating issues with space for the label.

GSK Consumer Healthcare proposes that similar additional clarification be written into the draft TGO 79 to account for (1) products in containers only (no primary outer packaging) with a surface area label size 60 cm2 or less and (2) products in intermediate-sized (25 to 100 mL or 25 to 100 g).

Medicine Information Panel

The draft TGO 79 [Section (10)(20)(a and b)] requires that all OTC medicines require a Medicine Information Panel on both the container and the primary pack (if present).

The proposal to standardise the back of the pack to contain a Medicine Information Panel represents a reasonable strategy that may aid consumers when locating information on the label. GSK Consumer Healthcare agrees in principle with the proposed Medicine Information Panel standardisation. However the following warrant some consideration to ensure that this system can function equally well across all OTC medicines.

Registered OTC medicines with negligible risk

The TGA has used a risk matrix to define levels of risk associated with OTC medicines in order to categorise applications for new and changed medicines and apply different data requirements and timelines to different risk categories.

GSK Consumer Healthcare proposes that this same risk matrix also be applied to OTC medicines to determine their requirement to have a Medicine Information Panel, with exclusions being applied to registered medicines deemed to have a negligible risk.

Products in small (or intermediate-sized) containers

The draft TGO 79 has made provision for products in small containers, but in doing has made the assumption that all small containers are contained within a primary pack which is also able to comply with TGO 79. This has the potential to cause difficulties, as demonstrated in case example 5.

GSK Consumer Healthcare proposes that in such cases where the product has an associated TGA approved package insert, a separate provision for the Medicines Information Panel should not be required on the primary pack.

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Products with a restricted surface area label size and no primary pack

Products with a surface area label size 60 cm2 or less have limited space which precludes the ability to provide the Medicines Information Panel as stated in the draft TGO 79.

GSK Consumer Healthcare proposes an exemption enabling modification of the required text in the Medicines Information Panel for products with small label surface areas, particularly those that fulfill the criteria of negligible risk.

Products whose current label contains no black text

The draft TGO 79 [section (10)(20)(f)] has made a provision for the use of colour in the headings of the Medicines Information Panel however at section (10)(20)(d) it is stipulated that the text within this Panel must be presented as black text on a white background. The mandated requirement for black text in the body of the Medicines Information Panel detracts from its legibility and changes the nature of the artwork with a subsequent increase in printing costs.

GSK Consumer Healthcare proposes that the provisions for the use of colour in section 10(20)(f) also be applied to section 10(20)(d) of the draft TGO 79.

Regulation Impact Statement

GSK Consumer Healthcare has reviewed the Regulation Impact Statement and supports Option 3 provided that the above-noted considerations and proposed solutions are able to be taken into account.

Process for changes

The TGA has developed the draft TGO 79 in response to prior consultation on this matter. However, despite the far-reaching changes there appears to be no further avenue for consultation after the present submissions are reviewed.

Further opportunities to review and discuss the details in the new legislation should be provided to enable a mutually acceptable position to be reached.

Lack of Trans-Tasman consultancy

GSK Consumer Healthcare supplies a number of products to both the Australian and the New Zealand market place; currently, approximately 95% of our packs are harmonised across these two markets. This agreed use of shared-labelling enables a cost-effective manufacturing and labelling process without issues relating to minimum order quantity impacting product sales in a much smaller market like New Zealand. Should the draft TGO 79 come into place without due consultation and acceptance by New Zealand there is inherent risk that Medsafe could reject the revised labelling with a potential to jeopardise the current arrangements and product supply in New Zealand.

GSK Consumer Healthcare seeks confirmation that the TGA will consult with Medsafe and secure New Zealand’s acceptance of the proposed changes prior to any legislation being mandated in Australia.

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Cost of compliance with the new order

The assumptions made with regard to the cost of compliance with the draft TGO 79 are based on “one-off costs” to those manufacturers who are not planning to make label changes during the relevant transition period. Whilst GSK Consumer Healthcare appreciates the amount of consultation that has been undertaken to develop these costs, the calculations do not account for the fact that the burden of change to be made will be borne by non-prescription products.

GSK Consumer Healthcare therefore requests a longer transition period of 5 years for OTC products.

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1. INTRODUCTION GlaxoSmithKline (GSK) is a global research-based pharmaceutical and healthcare company with a mission to improve the quality of human life by enabling people to do more, feel better and live longer.

In Australia, GSK has improved people’s wellbeing by delivering the highest quality medicines, vaccines and over-the-counter (OTC) healthcare products since 1886. The company provides over 1600 skilled jobs across the country, working with researchers and doctors to discover new ways of treating and preventing disease. In 2012 GSK invested $54 million in local research and development, and made significant contributions to Australia’s $4.2 billion pharmaceutical and medicinal exports.

GSK is sub-divided into a prescription division and a consumer healthcare division. The entire company concurs on the overall merits and issues of the proposals raised within the consultation documents. However, given the differences in how prescription and OTC medicines are regulated, labelled and supplied to consumers each division has submitted its own response to this consultation. This submission, therefore, focuses on the proposals and their implications as they relate to the OTC sector of the market only.

GSK Consumer Healthcare manufactures and markets a wide range of consumer products that are sold in pharmacies and supermarkets. The company’s most well-known product, Panadol®, is manufactured in many formats at the Sydney facility. [

OTC medicines are an essential, effective and convenient component of Australia’s healthcare system. It has been more than two decades since “self health care” was demonstrated to be a viable economic model for reducing the pressures of total health expenditure in Australia. The use of OTC medicines has evolved a great deal since this time and has brought with it important benefits. It has created more self-reliant consumers and significant cost savings to the healthcare system. In addition, industry-driven innovation in collaboration with Government, has meant that the use of OTC medicines has expanded beyond their traditional role in the symptomatic relief of common conditions such as minor pain, cough and colds, to one that now encompasses disease prevention (e.g. tooth decay, smoking cessation), cure (e.g. fungal infection) and the management of common recurrent conditions (e.g. heartburn, allergy).

GSK Consumer Healthcare welcomes viable initiatives to further support the safe and effective use of OTC medicines and acknowledges the intent behind the proposed regulatory changes to labelling. However, there is still some scope for improvement; this document provides commentary and suggestions to aid in achieving optimal compliance without negatively impacting the safe use of medicines.

The comments within this document represent the specific views of GSK Consumer Healthcare in relation to OTC medicines. They are intended to provide further insight over and above the general industry view that has been outlined in the Australian Self Medication Industry (ASMI) submission.

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2. FEEDBACK ON THE DRAFT TGO 79 Having reviewed available consultation documentation prepared by the TGA, GSK Consumer Healthcare has feedback on a number of aspects of the proposed draft TGO 79. This feedback focuses on the following core areas:

Transition timeframes [TGO 79, section 4] General requirements – label presentation [TGO 79, section 7] Information to be included on the main label [TGO 79, section 9] Small and very small containers [TGO 709, section 10(14) and 10(15)] Introduction of a Medicine Information Panel [TGO 79, section 10(20)]

2.1 TRANSITION TIMEFRAMES

The currently proposed transition timeframe of 3 or 4 years [Draft TGO 79, section 4] will place considerable pressure on GSK Consumer Healthcare.

The information provided in the regulation impact statement (v1.0 August 2014) suggests that on average it is normal business practice to make label changes every 3 years (page 22), but later acknowledge that approximately 75% of label changes would usually be made within a 4 year period (page 24).

Whilst these timeframes are cognizant of the fact that different companies are likely to have differing policies in place with regards to the reasons for and frequency of label changes, they still do not accommodate those companies that have a wide range of products with variable label change practices.

The above timeframes do not account for the pre-work that has to be undertaken before revised labelling is submitted to the TGA for approval. In our experience, this can take up to 24 months and typically includes stages 1 through 5 (of 7) in the ASMI “Labelling code of practice” – scoping, benchmarking, designing, testing with consumers, and refining. Then, once TGA approval is received implementation time is variable and further constrained by the viable transition period from old packs (currently on shelf) to new packs.

The proposed timeframes do not take account of potential implications as a result of future mergers and acquisitions. Such circumstances would require further review of all labelling, with significant additional time required.

Importantly, the discussions around timeframes have focused on the Sponsor’s requirements and do not appear to have taken account the need to consider the TGA’s ability to concurrently review and approve label change submissions from all Australian manufacturers.

The premise of the timeframes assumes that the label changes will impact only the Australian market. Exclusions are made for export only products [Draft TGO 79, section 5(1)(k)]. However the transition timeframe does not account for manufacturers who produce identical labels for use in multiple jurisdictions e.g. Australia and New Zealand. In such instances proposed label changes need to comply with two different sets of legislation and this warrants additional time to address potential issues that may arise.

GSK Consumer Healthcare Recommendation

Revise TGO 79, section 4 to allow for a minimum transition period of 5 years for non-prescription medicines.

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2.2 GENERAL REQUIREMENTS: LABEL PRESENTATION

2.2.1 Text Size: The need for clarity around the terminology and enforceability of “text size equivalents”

Text size is a crucial aspect of label compliance; when an agreed minimum is adhered to it aids in ensuring readability and conformity across different products and therapeutic categories. At the previous consultation, proposals for minimum font heights were specified in mm, which was in accordance with the letter height requirements set out in current TGO 69. Within the context of TGO 69 ‘letter height’ means the height of upper case (capital) letters or lower case letters having an ascender or descender, unless otherwise stated.

The draft TGO 79 has changed the way in which font size is specified by attempting to adopt a new approach. This new approach applies a ‘text size equivalent’ to accommodate the height and width of letters. This new approach is not a measurement system, rather it aims to set a benchmark or standard, based on the Arial typeface, within which specific point sizes are specified for different label applications and requirements at different sections in draft TGO 79 (detailed in Table 1, below). However, this new ‘font size equivalent’ approach creates difficulty in interpretation, application to label design and compliance.

Confusion over the use of different standards in different legislative instruments

The method of using minimum letter height, expressed in mm, is not exclusive to TGO 69. This method is still in use by the TGA in other aspects of the labeling legislation.

For example, the Poisons Standard 2014 provides specific information in relation to labels. In Part 2 (Labels and containers), in the general requirements it is specified at sub-paragraph 3(5) that text must be written in letters at least 1.5 mm in height and at sub-paragraph 4(2) it is specified that on a container which has a capacity of 20 mL the letters should be at least 1 mm in height.

The requirements for labelling and containers in the SUSMP are intended to integrate with existing legislative instruments for labelling and containers. However, the proposed draft TGO 79 has not taken this current document into account. As such, the two documents rely on different standards, with the potential to cause confusion as to which standard should be applied.

Complications of the proposed ‘text size equivalent’ system

The point system has been universally used for the last hundred years for expressing the size of type. With the adoption of personal computers from the 1980s, this system has been carried over to computer-assisted editing, type-setting and design. From its inception, however, it has had some significant drawbacks.

The “typographic point,” is expressed in a non-standard unit which has no coherent relationship to either the inch or the millimeter. This makes for particular difficulties in design and page layout because the designer, typically working in millimeters, is compelled to mix millimeters with points in order to specify type size or line-spacing.

In general, the "point size" of a font refers to the size of the x-height plus the ascender area size plus the descender area size. Whilst the x-height (as a component of point size) can be used to measure the height of letters with no ascenders/descenders, the point size gives no restrictions about the width of each character.

Table 1. Font size specifications listed in the draft TGO 79.

Section Applicability Font specifications 7(2)(d) Label, unless otherwise specified Text size not less than the equivalent of Arial 6 pt, sans serif 9(7)(a) Registered goods:

Name and quantity of the active ingredient(s) Text size not less than the equivalent of Arial 15 pt, sans serif

9(8)(a) & guidelines section 3.4.1

Registered goods with 4 or more active ingredients AND no Medicines Information panel Names of every active ingredient (and quantity/proportion)

Text size not less than the equivalent of Arial 12 pt, sans serif May be on the front, side or back panel

9(8)(a) & guidelines section 3.4.1

Registered goods with 4 or more active ingredients WITH a Medicines Information panel Names of every active ingredient (and quantity/proportion)

Text size not less than the equivalent of Arial 6 pt, sans serif and within the Medicines Information panel

10(4)(b,c,d) Injections with a container capacity ≤25 mL: Name of the medicine and active ingredients Other information (eg quantity, expiry date)

Text on the label on the container Text size not less than the equivalent of Arial 8 pt Text size not less than the equivalent of Arial 6 pt Note: for the Primary Pack label Text size not less than the equivalent of Arial 15 pt, sans serif

10(5)(b) Injections with a container capacity ≤2.5 mL: Name of the medicine and active ingredients Other information (eg quantity, expiry date)


10(9) Homeopathic medicines: Statement that the medicine is homeopathic

Text size not less than the equivalent of Arial 8 pt

10(10) Medicines containing homeopathic and non-homeopathic ingredients: Statement that the medicine contains homeopathic preparations

Text size not less than the equivalent of Arial 8 pt

10(11) Sunscreens preparations in pack sizes of ≤25 mL capacity:

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Information other than the sun protection factor Text size not less than the equivalent of Arial 4 pt

10(14)(b,c,d) Small containers capacity ≤25 mL: Name of the medicine and active ingredients Other information (eg quantity, expiry date)


10(15)(b) Very small containers capacity ≤2.5 mL: Name of the medicine and active ingredients Other information (eg quantity, expiry date)


20(c) Medicines Information panel: Heading “Medicine Information”

Text size no smaller than the text size used for the headings required to be in that panel

20(f) Medicines Information panel: Headings (Ingredients, Uses, Warnings, Directions for use, other information)

Highlight by the use of bold fonts, shading, box-borders, colour or other suitable means

20(g) Medicines Information panel: Warning statement sub-headings (do not use if etc)

Use of bold fonts but in a test size smaller than for the other headings

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This means that there is no direct relationship between point size and visual size, as typefaces differ greatly (Figure 1A). The only way to match the fonts is to set the block of text twice; once so it conforms to the mandated Arial point size and then again in the chosen typeface at a comparable point size (Figure 1B).

Whilst this is possible for the graphic designer it still presents a problem from the perspective of the Company as we have no objective way of testing that the chosen typeface and point size is compliant without asking for two sets of labels (one in Arial and one in our chosen typeface); doubling the costs and efforts of everyone involved.

Figure 1A: Different typefaces in the same point size

Typeface Point size

Figure 1B: Different typefaces set at different point sizes to meet a pre-defined type length

Typeface Point size

Solutions to help accommodate the proposed ‘text size equivalent’ system

Although mm heights are used in current legislative instruments the potential confusion has arisen because the wording is not always explicit as to which aspect of the letter is being referred. As demonstrated above, the most important factor in terms of visual or comparative size is the x-height.

Any potential for confusion can be easily clarified by being explicit about the use of x-heights. For example, by stating that the text must be of a type size not less than 1.5 mm based on the font’s lower case ‘e’.

In order to accommodate the proposed ‘text size equivalent’, and enhance ability to ensure compliance, GSK Consumer Healthcare asks that further clarification be written into the ‘Guidance for the labelling of medicines documentation’ [at Section 2.1 General requirements] and in each section of the draft TGO7 79 where a ‘text size equivalent’ is specified.

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Ideally, this clarification should include:

A written definition of the x-height (e.g. x-height in mm corresponds to the height of the font’s lower case ‘e’).

A visual example which depicts the point size and x-height to show how the dimensions are measured.

A tabulated conversion of Arial font size to mm equivalents for x-heights Revised wording to indicate the x-height equivalents each time the Arial point size is

specified.

Whilst such a conversion does not fully account for font width, it will provide a comprehensive standard metric unit of measurement that can be used as guidance for checking compliance when labels are being designed.


Revise each area of the draft TGO 79 in which a text size equivalent is mentioned. For example:

Current: 7(2)(d) Text size not less than the equivalent of Arial 6 pt, sans serif. Proposed: 7(2)(d) Text size not less than the equivalent of Arial 6 pt (≥ 1.0 mm based

on the font’s x-height or the height of its lower case ‘e’), sans serif.

Revise bullet point 4 of Section 2.1 General requirements of the ‘Guidance for the labelling of medicines documentation’ to include the following: in text size not less than the equivalent of 6 point Arial (≥ 1.0 mm based on the

font’s x-height or the height of its lower case ‘e’), unless specified elsewhere in TGO 79 [section (7)(2)(d)].

Adapt the text appearing beneath the bullet point to include a graphic such as that shown below and a table to provide approximate mm equivalents based on the x-height or the height of the lower case ‘e’ of Arial at different point sizes.

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2.3 INFORMATION TO BE INCLUDED ON THE MAIN LABEL

Unlike prescription drugs, the on-pack labeling is a critical element of an OTC medicine because it provides all of the information a consumer needs for the self-selection of a medicine and for its safe and effective use. Consumers use this information in two ways. In general terms, front of pack labeling is used predominantly at the point of purchase, to determine if a particular product is the right one for their particular symptoms or condition whilst the back of pack labeling is used at the point when they are ready to use the product.

The proposed regulatory changes are aimed at clarifying the label of medicines to better improve consumer safety and quality use of medicines. GSK Consumer Healthcare concurs with the overarching intent of clear labelling. However, the specifics of some of the proposed changes when applied to OTC medicines have unintended negative consequences and so warrant further discussion and clarification.

2.3.1 Minimise the impact on existing branding for OTC medicines

The draft TGO 79 [section (9)(2)] states that the name of the medicine must be presented in a continuous, uninterrupted manner and not be broken up by additional information, logos, background texts or graphics. This proposal presents issues for the labelling of many OTC medicines that already contain graphic/typographical elements as part of their established branding. For example:

Existing labels, Australia

Would GSK Consumer Healthcare be required to remove the bubbles from the O at the end of the established ENO brand name?

Would GSK Consumer Healthcare be required to remove the established circle branding device from behind Sensodyne brand name?

Would GSK Consumer Healthcare be required to ensure the entire name per the ARTG (PANADOL EXTRA WITH OPTIZORB FORMULATION) fits within the existing space directly beneath Panadol and inside the confines of the trade marked “beacon” device or does this necessitate the removal of the Panadol beacon device?

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GSK Consumer Healthcare notes that the impetus for the wording in the draft TGO 79 has come from the regulatory guidelines established by The Proprietary Association of Great Britain (PAGB). Despite the similarity in wording, examples of GSK Consumer Healthcare’s labels from the UK demonstrate considerable flexibility in the practical application of this wording that enables the retention of existing established branding devices.

Existing labels, UK

The draft TGO 79 [section (9)(3)] states that the name of the medicine and the active ingredients must be presented as a cohesive unit by placing the actives directly beneath the name of the medicine. For similar reasons to those expressed above, this proposal presents issues for the labelling of many OTC medicines.

A key consideration is the nature of medicines where there is an easily identifiable proprietary (brand) brand name (e.g. Panadol) which is then further differentiated by a sub-brand name (e.g. Extra, Children 1 month – 2 years, Cold & Flu Plus Decongestant, 5-12 Years Suppositories etc.) specific to the content and/or nature of use of the medicine. In such cases, the current primary label design shows the proprietary name in a consistent location with the specific sub-brand name in a secondary, but similarly consistent, location.

To accommodate the above two concerns regarding the name of the medicine on the label, GSK Consumer Healthcare asks that provisions be made such that:

existing branding/trade-marketed devices in use on non-prescription products be permitted to be retained

sub-brand names, with their associated active ingredients and quantities, may sit in a different location to the proprietary name provided that the positioning and orientation of this information conforms to the provisions in TGO 79.

The first of these can be achieved by enabling flexibility within the Australian environment (as has been demonstrated to have occurred within the UK). The second can be accommodated by

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re-phrasing of the definition of “name of the medicine” in TGO 79, retaining the definition for “proprietary name” (as per TGO 69) and providing some examples in the Guidance documentation.


Revise Section 3.1 General requirements of the ‘Guidance for the labelling of medicines documentation’ to include words to the effect that for non-prescription medicines flexibility will be permissible if the name of the medicine is presented in a cohesive/continuous manner despite the inclusion of established branding devices.

Revise TGO 79 [section 6], name of the medicine, (a) with the addition of a further sub-point after (i) to state (or words to this effect)

“the proprietary brand name where there is an established sub-brand name that is used to differentiate the specific content and/or nature of use of the medicine from others with the same primary brand name (for non-prescription medicines only)”

Revise TGO 79 [section 6], to include a new entry to define a proprietary name (per the existing TGO 69)

'Proprietary name' (the registered trade mark of the medicine or the unique name assigned to the medicine by the Sponsor and appearing on a label); or if there is no proprietary name.

2.3.2 Reduction in text size for active ingredients

The draft TGO 79 [section (9)(7)(a)] states that the name of the active ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed in a text size of not less that the equivalent of 15 point Arial in any sans serif font.

GSK Consumer Healthcare agrees that educating consumers on the active ingredients in the medicines they take is important for the quality use of medicines; this information is an aid to accurate identification of the medicinal product they are using. Given that the intent is to ensure the consumer becomes aware of and takes note of this information, several factors need to be considered to ensure that the information is legible. Research shows that to improve message legibility due consideration should be given to the font’s x-height (in preference to point size), font type, sans serif typefaces, letter spacing, line spacing, use of “white space”, use of bold text and judicious use of colour (both of the text and the background).1

The nominated text size equivalent of 15 point Arial causes presentation issues for the labelling of many OTC medicines, particularly:

• because unlike prescription medicines, OTC medicines carry the indications and/or important product features on the front of pack to aid product self-selection

• those with up to three active ingredients or • those that have small or irregular label sizes.

The large font size limits the ability of Sponsors to adequately display the required information without causing unintended confusion.

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To illustrate some of the inherent issues involved, GSK Consumer Healthcare has used the draft TGO 79 to create sample labels for a number of products. We provide below a copy of the front label as it currently exists, a revised label that follows the provisions set out in the draft TGO 79 and then a recommended modification to the label.

CASE EXAMPLE 1: ENO

Eno is an effervescent powder for the temporary relief of heartburn and acid indigestion. Eno contains three active ingredients, which excludes it from the provisions in the draft TGO 79 [section (9)(8)(a)]. It is sold in a bottle containing 200 g of active product and as such is not considered to be a small container. The label size that fits the 200 g bottle is 60 mm wide by 65 mm tall.

Importantly, as this product illustrates, to accommodate the changes in the draft TGO 79 all revisions will also need to conform to this label size. However, no provisions have been made with the draft TGO 79 for containers with small label sizes.

The Regulation Impact Statement stipulates that the proposed changes to TGO 79 are not expected to add costs; the premise for this being that Sponsors will be able to accommodate label changes with existing processes. Without some consideration of the ability to use a smaller text size, the ENO product would be forced to be supplied in an additional outer pack (carton) adding considerable cost to its manufacture and, ultimately, to the consumer.

Current label TGO 79 label Proposed label

Key issues: 15 point Arial text size equivalent is too large for this label size; it takes the label text outside of the pre-set area.

Solution: In this case all required labelling text can only be accommodated at a size that is an 8 point Arial text size equivalent.

CASE EXAMPLE 2: Panadol Cold & Flu

Panadol Cold & Flu is a combination tablet product that contains three active ingredients, which again excludes it from the provisions in the draft TGO 79 [section (9)(8)(a)].

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The names of the active ingredients are usually listed as their respective salts; in this case they are Paracetamol 500 mg, Dextromehtorphan Hydrobromide 15 mg and Phenylephrine Hydrochloride 5 mg. The name length of these active ingredients makes it difficult to ensure that they can fit into the space provided in a text size equivalent to 15 point Arial.

The information provided at section 4.1 of the guidance document indicates that where there is only one salt registered in Australia then it is permissible to include just the free acid or free base (herein described as the “short form name”) on the primary pack provided the name of the salt is included on one panel.

Given that this product will require a Medicines Information Panel on the Iabel, it is proposed that the short form name be included on the front panel and the name of the full salt be included on the back panel.

Clarity is however sought over the inclusion of the quantity. The guidance document is silent on this aspect of the labelling. Where the short form name is to be used it would be confusing to put a quantity amount as this would differ from the quantity against the name of the full salt on the back panel, making it difficult for the consumer to interpret.

GSK Consumer Healthcare therefore suggests that on the front of the pack the short form name should be presented with no quantity provided that the label also includes the quantity and name of the full salt elsewhere.


A.

B.

Key issues: 15 point Arial text size equivalent is too large; it takes the label text outside of the pre-set area.

Solution: In this case all required labelling text can only be accommodated by:

A. Reducing the font size to below 10 point Arial, or B. Listing the three active ingredients (short form names, no quantity)

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at a 12 point Arial text size equivalent on the front of the label and the name of the full salt and its quantity in 6 point Arial text size equivalent in the Medicines Information Panel on the back of the label.

Of note, solution B is similar to that which has been adopted in the UK, as shown in the example below.

CASE EXAMPLE 3: Panadol Extra

Panadol Extra is an analgesic that contains two active ingredients. Even a product with two active ingredients, such as Panadol Extra, cannot be accommodated in the manner set out in the draft TGO 79.


Key issues: 15 point Arial text size equivalent is too large to fit in a cohesive unit beneath the primary brand name.

Solution: In this case all required labelling text can only be accommodated at 12 point Arial text size equivalent and by allowing flexibility such that the active ingredients are situated beneath the sub-brand name (per the recommended

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UK format).

CASE EXAMPLE 4: Panadol

Panadol tablets contain only one active ingredient, yet the 15 point Arial font is still not able to be accommodated within the confines of the existing pack design.

Current label

TGO 79 label

Proposed label

Key issues: 15 point Arial text size equivalent is too large to fit in a cohesive unit beneath the primary brand name.

Solution: In this case all required labelling text can only be accommodated at 12 point Arial text size equivalent and by allowing flexibility such that the active ingredients are situated beneath the sub-brand name (per the allowable UK format).

CASE EXAMPLE 5: Medicines with a small primary pack

The provisions made for labelling small containers have failed to consider the size of the primary pack. By the very nature of the products being supplied, the primary pack is also of limited size which makes it difficult to accommodate the required labelling information. Below we provide an example based on Duofilm Solution. This product meets the requirements of a small container and is housed in a primary pack. However, the limited space on the primary

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pack precludes the ability to provide the name and quantity of the active ingredients in a text size of not less that the equivalent of 15 point Arial in any sans serif font as stated in the draft TGO 79.


Key issues: 15 point Arial text size equivalent is too large to fit the active ingredient names and quantities on the front of this pack

Solution: In this case the active ingredient names and their quantities required on the front of the label can only be accommodated at 10 point Arial text size equivalent.

2.3.3 Special consideration for OTC products containing four or more active ingredients

The draft TGO 79 [section (9)(8)(a) and (b)] is intended to accommodate the needs of products which contain four or more active ingredients. Based on the information at draft TGO 79 section (10)(20) and in the Guidance document (Section 3.4.1), GSK Consumer Healthcare has interpreted this section to mean that its OTC products which contain four or more active ingredients are only required to have the full list of active ingredients and their quantities listed inside the Medicines Information Panel on the back of the label in a text size not less than 6 point Arial. Nothing need be displayed on the main (front of pack) label.

Not listing the names of the active ingredients on the front panel makes it harder for a consumer to determine what is in it and negates the rationale for draft TGO 79.

GSK Consumer Healthcare has been able to accommodate the information on both panels by adopting a system similar to that used in the UK (as suggested above for products with three active ingredients), whereby the short form name of the active ingredients without quantity are listed on the front panel and the name of the full salt including its quantity are listed within the Medicines Information Panel on the back of the label.

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CASE EXAMPLE 6: Panadol cold and Flu; Flu Strength Day & Night

Where the names and quantities of the active ingredients are permitted to be in the Medicines Information Panel, there is some flexibility to also include them on the front panel provided a short-form name is permitted to be used.


Key issues: Not listing the names of the active ingredients on the front panel makes it harder for a consumer to determine what is in it (negating to some extent the rationale for the draft TGO 79).

Solution: In this case it may be possible to fit the short form names of the active ingredients on the front of the label and the full names of the active ingredients and their quantities in 6 point Arial text size equivalent in the Medicines Information Panel on the back of the label.

To accommodate the above concerns regarding the listing of the active ingredients on the main label, GSK Consumer Healthcare asks that provisions be made such that:

the active ingredient(s) and the quantity or proportion of active ingredient(s) may be displayed in a text size of not less that the equivalent of 10 point Arial in any sans serif font,

the active ingredient(s) and the quantity or proportion of active ingredient(s) may be displayed directly beneath the sub-brand names, and

where the full names of the active ingredients make it impossible to list them on the front panel, the short form names (minus quantity) may be listed with the full details provided on the back panel.

The first of these can be achieved by reducing the minimum text size from 15 point Arial equivalent to a 10 point Arial equivalent. The second and third can be accommodated by enabling flexibility within the Australian environment (as has been demonstrated to have occurred within the UK).

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TGO 79 [section (9)(7)(a)] to state:

the name of the active ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed in a text size of not less that the equivalent of 10 point Arial in any sans serif font.

Revise Section 3.4.1 names of registered medicines of the ‘Guidance for the labelling of medicines documentation’ to include words to the effect that for non-prescription medicines with less than 4 active ingredients which cannot be accommodated in full in a text size equivalent to 10 point Arial then the active ingredient (without their salts [short form names]) may appear on the front panel provided that the full active ingredients and their proportion/quantity appear in the Medicines Information Panel on the back of the pack.

Revise Section 4.1 Salts, hydrates and solvates of the ‘Guidance for the labelling of medicines documentation’ to clarify that where only one salt is registered in Australia, the name of the free acid or free base (short form name) may be used without including its quantity provided that the name of the full salt and its quantity is included in at least one panel of the label.

2.4 SMALL AND VERY SMALL CONTAINERS

Special provisions have been put in place in an attempt to accommodate the restricted space for information on the labels of small containers (defined as containers that have a nominal capacity of between 2.5 and 25 mL) and very small containers (defined as containers that have a nominal capacity of 2.5 mL or less).

The draft TGO 79 has made a number of provisions for small containers such that the labelling requirements of the container are less than they have been previously, provided that the primary pack is fully compliant. However, a number of areas require clarification to ensure the practicability of the recommendations in the draft TGO 79. Discussed here are issues relating to the definition of a “small container”. Related issues concerning the labelling of the primary pack were discussed in the previous section of this document.

2.4.1 Expansion of the definition of “small container”

GSK Consumer Healthcare notes that the capacity of a small container has been increased from 20 mL to 25 mL. However, the current definition of a small container is based on nominal capacity and therefore only relates to products supplied in liquid form in small amounts. This definition excludes certain other packaging formats that are limited by their size and forces them to conform to the revised requirements for normal sized products, creating issues with space for the label. Examples include:

• Label size – As has been described in case example 1 (Eno), above, some products are packaged only in primary containers that have a limited label size despite their capacity being larger than 25 mL.

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• Products packaged by count – some products are packaged by count in containers that have a capacity greater than 25 mL but are still too small to accommodate all the requirements of the labelling on a larger primary pack. For example, Panadol Suppositories 125 mg 6 months – 5 years are packed in counts of 20 in a bottle of capacity 45 mL but the label size precludes the ability to include all of the recommendations in the draft TGO 79.

• Semi-solid products – semi-solid products are filled by volume but sold by weight in Australia (e.g. Hydrozole Cream 30 g). The requirements of the small container size needs to account for such products.

The draft TGO 79 makes provision for injections with a nominal volume less than 100 mL but greater than 25 mL. GSK Consumer Healthcare believes that the above issues could be circumvented by providing similar additional clarification in the TGO 79 to account for:

• Products in containers only (no primary outer packaging) with a restricted surface area label size (nominally defined as being 60 cm2 or less).

• Products in intermediate-sized containers (nominally defined as being 25 to 100 mL or 25 to 100 g).


Revise TGO 79 [section 6], with the addition of new definitions for the following:

intermediate-sized container means a container which has a capacity less than or equal to 100 mL / 100 g that is not a small container

restricted surface area label size means any label affixed to a container that serves as the primary pack and has a surface area of less than or equal to 60 cm2

Revise TGO 79 [section (10)], with the addition of a new subsection (nominally before the current sub-section 14) to accommodate labelling requirements for intermediate-sized containers in the same way that injections with a nominal volume of 100 mL or less have been treated separately from those with nominal volumes of 25 ml or less.

Revise TGO 79 [section (10)], with the addition of a new subsection (nominally after the current sub-section 15) to accommodate labelling requirements for containers with a restricted surface area label size that are not packaged in a separate primary pack.

Revise Section 9.11 Small and very small containers of the ‘Guidance for the labelling of medicines documentation’ to include a section on the specific labelling requirements for intermediate-sized containers (25-100 mL in capacity).

2.5 INTRODUCTION OF A MEDICINE INFORMATION PANEL

The draft TGO 79 [Section (10)(20)(a and b)] requires that all OTC medicines require a Medicine Information Panel on both the container and the primary pack (if present).

The proposal to standardise the back of the pack to contain a Medicine Information Panel represents a reasonable strategy that will greatly aid consumers when locating information on the label. Such standardisation presents the information in a uniform manner, uses simple to

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read language and an easy to use format that enables consumers to compare and select OTC medicines and follow the required dosage instructions.

GSK Consumer Healthcare agrees in principle with the proposed Medicine Information Panel standardisation and recognises that some change will be necessary to convert medicines to this new system. However some refinements and caveats need to be accounted for in order to ensure that this system works equally well across all OTC medicines. The key areas for discussion include the applicability of the Medicine Information Panel to:

• Registered OTC medicines with negligible risk • Products in small (or intermediate-sized) containers • Products with a restricted surface area label size and no primary pack

2.5.1 Registered OTC medicines with negligible risk

As part of the OTC medicines business process reform, the TGA has recently considered the application of risk management principles, as described in the international risk management standard, ISO 31000:2009, to the regulation of therapeutic products. Risks are rated in terms of the likelihood of an event occurring and the consequence if it were to occur. In this context, likelihood describes the chance of something happening and consequence describes the outcome of an event affecting objectives.

The TGA has used a risk matrix (see chart below) to define levels of risk associated with OTC medicines in order to categorise applications for new and changed medicines and apply different data requirements and timelines to different risk categories.

General framework for risk assessment and rating

GSK Consumer Healthcare proposes that this same risk matrix also be applied to OTC medicines to determine their requirement to have a Medicine Information Panel, with exclusions being applied to registered medicines deemed to have a negligible risk. Such a risk assessment would, therefore, exclude such products as toothpastes, antacids, acne-creams and hand sanitisers from the requirement to have a Medicine Information Panel.

2.5.2 Products in small (or intermediate-sized) containers

The draft TGO 79 has made provision for products in small containers, but in doing has made the assumption that all small containers are contained within a primary pack which is also able to comply with TGO 79. This has the potential to cause difficulties, as demonstrated in case example 5 and in the following examples.

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GSK Consumer Healthcare proposes that in such cases where the product has an associated TGA approved package insert, a separate provision for the Medicines Information Panel should not be required on the primary pack.

CASE EXAMPLE 7: Medicines without a primary pack

Many OTC medicines are sold in small containers, or in the various additional descriptors thereof (outlined above) but do not come in a primary pack. Below we provide an example based on Panadol Suppositories for use in children.

This product meets the proposed requirements of an intermediate-sized container but has no primary pack precluding the ability to provide the Medicines Information Panel as stated in the draft TGO 79.

2.5.3 Products with a restricted surface area label size and no primary pack

CASE EXAMPLE 8: Limited label space

As has been previously discussed Eno, is sold in a bottle containing 200 g with a corresponding label size of 60 mm x 65 mm (39 cm2). The limited space on the container label precludes the ability to provide the Medicines Information Panel as stated in the draft TGO 79.


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Key issues: The diagram for the TGO 79 label shows that the required text for the Medicines Information Panel will not fit on the label. The smaller of the two boxes shows the amount of text that will not fit within the confines of the label space.

Even after modification (e.g. removal of the Medicines Information heading and horizontal hairlines) the required text still does not fit to the restricted size of the label

Solution: GSK Consumer Healthcare proposes an exemption enabling modification of required text in the Medicines Information Panel for products with small label surface areas with no requirement for change from the existing labelling for those that fulfill the criteria of negligible risk.

2.5.4 Unnecessary colour restrictions

CASE EXAMPLE 9: Hydrozole

The draft TGO 79 [section (10)(20)(f)] has made a provision for the use of colour in the headings of the Medicines Information Panel however at section (10)(20)(d) it is stipulated that the text within this Panel must be presented as black text on a white background.

This does not take into account those medicines that do not currently have black text on their label. Accommodating black text into the existing label requires that a new colour be added to the artwork, with an inherent increase in print costs.

Importantly, the introduction of black text only in a specific portion of the label detracts from its readability and undermines the purpose and utility of the Medicines Information Panel, as can be seen in the following example.

TGO 79 label with Medicines Information Panel text in black on white:

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Proposed label with Medicines Information Panel text in the same colour as is permitted in the headings:

Key issues: The mandated requirement for black text in the body of the Medicines Information Panel detracts from its legibility and changes the nature of the artwork with a subsequent increase in printing costs.

Solution: GSK Consumer Healthcare proposes that the provisions for the use of colour in section 10(20)(f) also be applied to section 10(20)(d) of the draft TGO 79.

2.5.5 Proposed solution for issues relating to the Medicines Information Panel

As can be seen in the above examples, the most difficult issue with small containers for OTC medicines is the need to include a Medicine Information Panel on the primary pack. GSK Consumer Healthcare believes that the above issues could be circumvented by providing modifications for the requirements of a Medicines Information Panel to accommodate the following:

Medicines Information Panel

Registered OTC medicines with negligible risk Not required

Registered Schedule 2 medicines packaged in small and very small sized containers but which have an approved package insert

Not required

Products packaged in intermediate sized containers with no primary pack

Modified wording on the container label

Products packaged in small and very small sized containers Modified wording on the

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with no primary pack container label

Products packaged in containers with a restricted surface area label size and no primary pack

Modified wording

Products packaged in a tube with a primary container that complies

Not required on the tube

Products with compliant existing packaging that does not already include black text

Modification to allow use of coloured text instead of black and white.


Revise TGO 79 [section 6], with the addition of a new definition for the following:

negligible risk means a registered medicine for which it has been determined that the associated likelihood and consequences of risk fall into one of the following five categories possible/negligible; unlikely/negligible; unlikely/low; very unlikely/negligible; very unlikely/low

Revise TGO 79 [section (10)(20)(a)], to reflect that the requirements of this subsection do not apply to:

• registered medicines assessed as being of negligible risk • Medicines classified in Schedule 2 of the SUSMP provided that they have an

approved package insert.

Revise TGO 79 [section (10)(20)], with the addition of a new subsection (k) to accommodate modified/reduced wording requirements where it is impractical to include the entire contents of Medicine Information Panel even over two or more panels of the primary label.

Revise TGO 79 [section (10)(20)(d)], to permit that if no black text appears elsewhere on the label, the information required in the body of the Medicines Information Panel may be presented in a colour that matches that used in the label.

Revise Section 6.2 Registered non-prescription medicines – Medicine Information panel of the ‘Guidance for the labelling of medicines documentation’ accommodate the proposed revisions with respect to medicines of negligible risk, medicines in small containers with a TGA-approved package insert and instances where it is impossible to include all of the required information.

3. FEEDBACK ON THE REGULATION IMPACT STATEMENT GSK Consumer Healthcare has reviewed the Regulation Impact Statement and supports Option 3 provided that the above-noted considerations and proposed solutions are able to be taken into account.

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With regards to the benefits of this option, GSK Consumer Healthcare would like to comment on the following:

• Process for changes • Lack of Trans-Tasman consultancy • Cost of compliance with the new order

3.1 PROCESS FOR CHANGES

The TGA has developed the draft TGO 79 in response to prior consultation on this matter. However, despite the far-reaching changes there appears to be no further avenue for consultation after the present submissions are reviewed.

Given the breadth of the changes, the various options outlined in the Regulation Impact Statement and the proposed range of different transition periods, we propose that the TGA at least outline a process for further input and clarification by industry stakeholders. This would enable the true impacts of the proposals to be evaluated and any unforeseen problems to be identified and dealt with accordingly. Further opportunities to review and discuss the details in the new legislation should be provided to enable a mutually acceptable position to be reached.

3.2 LACK OF TRANS-TASMAN CONSULTANCY

At page 26 in the Regulatory Impact Statement, the discussions and consultations with a wide range of groups is described. It is notable, however, that this regulatory review into the labelling of medicines has been undertaken by the TGA without consultation with Medsafe.

GSK Consumer Healthcare supplies a number of products to both the Australian and the New Zealand market place and, at present, these products share the same labelling. Currently, approximately 95% of our packs are harmonised across Australia-New Zealand. This agreed use of shared-labelling enables a cost-effective manufacturing and labelling process without issues relating to minimum order quantity.

Should the draft TGO 79 come into place without due consultation with New Zealand there is inherent risk that Medsafe could reject the revised labelling. In such a situation, GSK Consumer Healthcare would be required to run separate production lines for labels to be used in Australia and in New Zealand. This would have a net negative impact. The New Zealand market is unlikely to be able to meet the minimum order quantities required for them to have a bespoke pack. Ultimately this would result in the loss of many of these products in that market.

In view of this, GSK Consumer Healthcare seeks confirmation that the TGA will consult with Medsafe and secure New Zealand’s acceptance of the proposed changes prior to any legislation being mandated in Australia.

3.3 COST OF COMPLIANCE WITH THE NEW ORDER

The assumptions made with regard to the cost of compliance with the draft TGO 79 are based on “one-off costs” to those manufacturers who are not planning to make label changes during the relevant transition period. Whilst GSK Consumer Healthcare appreciates the amount of

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consultation that has been undertaken to develop these costs the calculations do not account for the fact that the burden of change to be made will be borne by non-prescription products. It is for this reason that GSK Consumer Healthcare requests a longer transition period for OTC products.

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4. SUMMARY AND OVERVIEW OF OPINION ON RECOMMENDATIONS The following table has been developed to provide an at-a-glance summary of the opinions and recommendations of GSK Consumer Healthcare relating to specific sections of the draft TGO 79.

Proposed regulatory change General opinion Recommendations

Transition timeframes

Draft TGO Section 4 Consideration of the burden placed on non-prescription products is required

Revise TGO 79, section 4 to allow for a minimum transition period of 5 years for non-prescription medicine.

General requirements: label presentation

Draft TGO Section (7)(2)(d)

Text Size: The need for clarity around the terminology and enforceability of “text size equivalents”

The new ‘font size equivalent’ approach creates difficulty in interpretation, application to label design and compliance

Revise each area of the draft TGO 79 in which a text size equivalent is mentioned. For example:

Current: 7(2)(d) Text size not less than the equivalent of Arial 6 pt, sans serif.

Proposed: 7(2)(d) Text size not less than the equivalent of Arial 6 pt (≥ 1.0 mm based on the font’s x-height or the height of its lower case ‘e’), sans serif.

Revise bullet point 4 of Section 2.1 General requirements of the ‘Guidance for the labelling of medicines documentation’ to include the following:

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in text size not less than the equivalent of 6 point Arial (≥ 1.0 mm based on the font’s x-height or the height of its lower case ‘e’), unless specified elsewhere in TGO 79 [section (7)(2)(d)].

Information to be included on the main label

Draft TGO Section (9)(2) and (3)

Minimise the impact on existing branding for OTC medicines

This proposal presents issues for the labelling of many OTC medicines that already contain graphic/typographical elements as part of their established branding

Revise Section 3.1 General requirements of the ‘Guidance for the labelling of medicines documentation’ to include words to the effect that for non-prescription medicines flexibility will permissible if the name of the medicine is presented in a cohesive/continuous manner despite the inclusion of established branding devices.

Revise TGO 79 [section 6, name of the medicine, (a) with the addition of a further sub-point after (i) to state (or words to this effect)

“the proprietary brand name where there is an established sub-brand name that is used to differentiate the specific content and/or nature of use of the medicine from others with the same primary brand name (for non-prescription medicines only)”

Revise TGO 79 [section 6], to include a new entry to define a proprietary name (per the existing TGO 69)

'Proprietary name' (the registered trade mark of the medicine or the unique name assigned to the medicine by the Sponsor and appearing on a label); or if there is no proprietary name.

Draft TGO Section (9)(7)(a)

Reduction in text size for active ingredients

The nominated text size equivalent of 15 point Arial causing presentation

Revise TGO 79 [section (9)(7)(a)] to state:

the name of the active ingredient(s) and the quantity or proportion

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issues for the labelling of many OTC medicines, particularly those with up to three active ingredient or those that have small or irregular label sizes.

of active ingredient(s) must be displayed in a text size of not less that the equivalent of 10 point Arial in any sans serif font.

Draft TGO Section (9)(7)(a)

Special consideration for OTC products containing four or more active ingredients

Clarification is required as to whether the quantity is also needed when the short form name is used on the front of pack

Revise Section 3.4.1 names of registered medicines of the ‘Guidance for the labelling of medicines documentation’ to include words to the effect that for non-prescription medicines with less than 4 active ingredients which cannot be accommodated in full in a text size equivalent to 10 point Arial then the active ingredient (without their salts [short form names]) may appear on the front panel provided that the full active ingredients and their proportion/quantity appear in the Medicines Information Panel on the back of the pack.

Revise Section 4.1 Salts, hydrates and solvates of the ‘Guidance for the labelling of medicines documentation’ to clarify that where only one salt is registered in Australia, the name of the free acid or free base (short form name) may be used without including its quantity provided that the name of the full salt and its quantity is included in at least one panel of the label.

Small and very small containers

Draft TGO Section (10)(14)

Expansion of the definition of “small container”

The current definition of a small container is based on nominal capacity and therefore only relates to products supplied in

Revise TGO 79 [section 6], with the addition of new definitions for the following:

intermediate-sized container means a container which has a capacity less than or equal to 100 millilitres that is not a small

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liquid form in small amounts. This definition excludes certain other packaging formats that are limited by their size and forces them to conform to the revised requirements for normal sized products, creating issues with space for the label.

container

restricted surface area label size means any label affixed to a container that serves as the primary pack and has a surface area of less than or equal to 60 cm2

Revise TGO 79 [section (10)], with the addition of a new subsection (nominally before the current sub-section 14) to accommodate labelling requirements for intermediate-sized containers in the same way that injections with a nominal volume of 100 mL or less have been treated separately from those with nominal volumes of 25 ml or less.

Revise TGO 79 [section (10)], with the addition of a new subsection (nominally after the current sub-section 15) to accommodate labelling requirements for containers with a restricted surface area label size that are not packaged in a separate primary pack.

Revise Section 9.11 Small and very small containers of the ‘Guidance for the labelling of medicines documentation’ to include a section on the specific labelling requirements for intermediate-sized containers (25-100 mL in capacity).

Medicine Information Panel


Registered OTC medicines with negligible risk

GSK Consumer Healthcare agrees in principle with the proposed Medicine Information Panel standardization. However some refinements and

GSK Consumer Healthcare proposes that a risk matrix be applied to OTC medicines to determine their requirement to have a Medicine Information Panel, with exclusions being applied to registered medicines deemed to have a negligible risk.

Such a risk assessment would therefore exclude such products as toothpastes, antacids, acne-creams and hand sanitisers from the

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caveats need to be accounted for in order to ensure that this system works equally well across all OTC medicines.

requirement it have a Medicine Information Panel.

Revise TGO 79 [section 6], with the addition of a new definition for the following:

negligible risk means a registered medicine for which it has been determined that the associated likelihood and consequences of risk fall into one of the following five categories possible/negligible; unlikely/negligible; unlikely/low; very unlikely/negligible; very unlikely/low

Revise TGO 79 [section (10)(20)(a)], to reflect that the requirements of this subsection do not apply to:

• registered medicines assessed as being of negligible risk • Medicines classified in Schedule 2 of the SUSMP provided

that they have an approved package insert.


Products in small (or intermediate-sized) containers AND Products with a restricted surface area label size and no primary pack

The practical difficulties associated with labelling small containers are not negated by their enclosure in a primary pack. By the very nature of the products being supplied, the primary pack is also of limited size which makes it difficult to accommodate the required labelling information. The most difficult issue with small containers for OTC

Revise TGO 79 [section (10)(20)], with the addition of a new subsection (k) to accommodate modified/reduced wording requirements where it is impractical to include the entire contents of Medicine Information Panel even over two or more panels of the primary label.

Revise Section 6.2 Registered non-prescription medicines – Medicine Information panel of the ‘Guidance for the labelling of medicines documentation’ accommodate the proposed revisions with respect to medicines of negligible risk, medicines in small containers with a TGA-approved CMI and instances where it is impossible to include all of the required information.

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medicines is the need to include a Medicine Information Panel on the primary pack.

Draft TGO Section (10)(20)(d)

With the exception of the headings, the text within the Medicines Information Panel must be black n a white background

Accommodating black text when it is not part of the existing label design will increase the costs of the label products. Enforced use of black text does not improve readability.

Revise TGO 79 [section (10)(20)(d)], to permit that if no black text appears elsewhere on the label, the information required in the body of the Medicines Information Panel may be presented in a colour that matches that used in the label.

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5. REFERENCE MATERIALS Copies of reference materials can be made available upon request.

1. Bix L. The elements of text and message design and their impact on message legibility: A literature review. Journal of Design Communication 2002;Spring(4):1-10.

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