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Australian Self Medication Industry (ASMI)

Suite 2202, Level 22 141 Walker St,

North Sydney NSW 2060 Ph: 02 9922 5111 Fax: 02 9959 3693

ASMI Response to the

TGA Medicine Labelling

Consultation

Draft TGO 79

November 2014

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INDEX

Table of Contents

INDEX ...................................................................................................................................................... 2

PART 1 – ASMI RESPONSE AND COMMENTS ON THE DRAFT TGO 79 .................................................. 3

EXECUTIVE SUMMARY ............................................................................................................................ 4

GENERAL OVERVIEW OF DRAFT THERAPEUTIC GOODS ORDER 79 ........................................................ 7

DRAFT TGO 79 – SPECIFIC CONCERNS .................................................................................................. 13

ASMI RECOMMENDATIONS FOR AMENDING TGO 79 .......................................................................... 54

PART 2 - SECTION BY SECTION DETAILED REVIEW OF DRAFT TGO 79 ................................................ 59

PART 3 – ASMI RESPONSE TO REGULATION IMPACT STATEMENT .................................................... 96

PART 4 – ASMI RESPONSE TO GUIDELINE FOR THE LABELLING OF MEDICINES ............................... 118

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PART 1 – ASMI RESPONSE AND COMMENTS ON THE

DRAFT TGO 79

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EXECUTIVE SUMMARY ASMI appreciates the opportunity to provide comment on the TGA Medicine Labelling

Consultation, consisting of the draft Therapeutic Goods Order (TGO) 79, together with the

related guidelines and the Regulation Impact Statement (RIS). ASMI is the peak body

representing companies involved in the manufacture and distribution of consumer

healthcare products (non-prescription medicines) in Australia and as an organisation is

committed to the principles of Quality Use of Medicine.

For non-prescription medicines, the labelling is the most important source of information

for consumers. It allows consumers to select appropriate medicines and use them safely. It

is therefore in the interests of the community for non-prescription medicine labelling to be

well designed and effective.

In general, non-prescription medicines are lower-risk medicines, and unscheduled medicines are available for consumer self-selection. The labelling requirements for non-prescription medicines are therefore different to those for prescription medicines, and the labelling Order should reflect this. Non-prescription medicines require more information on labelling compared to prescription medicines, including information on uses, directions for use, and warning statements, and other properties of the medicine. Branding is important for non-prescription medicines, and consumers are familiar with many well-known brands of medicines for pain relief, cough and cold, allergy, skincare, and many other categories. Limited label space is therefore an important issue, particularly for certain product and label types. ASMI welcomes discussion on labelling reform and has contributed to discussions on labelling over many years, and in particular since the 2012 labelling consultation. Industry requires the labelling Order to be easy for industry to transition to and implement, that it should avoid impact on branding, not interfere with trademarks, and not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine. It should not require changes to packaging equipment to achieve compliance. Compliance with the Order should be achievable on all but very few, exceptional products in order to avoid applications for S14 exemptions, which do not provide business certainty and should not be used as a means of addressing inherent deficiencies within the Order or unachievable regulatory requirements. The labelling Order itself should be readily understood by both regulatory and non-regulatory personnel to facilitate production of compliant labelling. It should be clear and easy to interpret. ASMI acknowledges the TGA’s stated position in relation to the labelling reform, and agree with the following overarching principles:

There should be some increase in active ingredient prominence compared to status quo

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For registered non-prescription medicines, some uniformity of presentation of back-of-pack information is desirable

There should be no impact on branding or interference with trademarks

No changes should be needed to packaging details or dimensions, or capital upgrades or packaging equipment changes

The aim should be to adopt elements of the UK requirements, as practiced ASMI has examined the draft TGO 79 in detail and member companies have performed testing of the proposed requirements. Substantial change to the Order is required, as ASMI believes that the impact on non-prescription medicine labelling is significant and disproportionate to the low-risk nature of the vast majority of these medicines. In ASMI’s view, it does not reflect the practice of the UK. The UK requirements are different in relation to scheduling, signal headers and expression of active ingredient name and quantity, so the Australian labelling Order must consider the additional constraints on label space imposed these additional requirements not present in the UK. Testing of the draft Order has shown that the proposed active ingredient prominence of equivalent to 15 points Arial is unable to be achieved on many, if not most, non-prescription medicines. If implemented, it will cause major difficulty and be inconsistent with the TGA’s stated position that it does not intend to impact branding or interfere with trademarks, and it will necessarily lead to increases in packaging / labelling dimensions. ASMI agrees that some back of pack uniformity is desirable, however the Order should set a benchmark of minimum requirements for the type of information needed and how it should be grouped, but allow more flexibility so that the information can be accommodated on the majority of medicine labels. The proposed requirements for the Medicine Information Panel (MIP) are also unachievable, particularly for products that have limited label space. ASMI opposes the proposed font size of equivalent to 15 points Arial on non-prescription medicines and advocates for different requirements for non-prescription medicines, in keeping with a risk-based approach and recognizing some of the additional labelling information that is needed on these medicines, that has an impact on available space. ASMI members have undertaken considerable work to try and identify a font size that both

achieves increased prominence compared to TGO 69, but that is achievable on the vast

majority of labelling, including those with limited label space. This is discussed in more detail

in this submission. ASMI proposes alternative approaches to active ingredient prominence

and flexibility for smaller packs.

ASMI believes that the labelling Order should be risk-based, and one way of achieving this is

to separate out the requirements for listed medicines, prescription medicines and

registered non-prescription medicines. This categorisation is used frequently throughout the

Order for a range of other requirements including dispensing label space, barcoding,

warning statements, the Medicine Information Panel, so there is no reason why active

ingredient prominence cannot also be separated according to prescription vs non-

prescription medicines in relation to registered medicines. The Order could be further

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clarified by providing separate chapters for the specific requirements for each of these

medicine types.

In relation to the Regulation Impact Statement, ASMI is concerned that the assumptions

used to underpin the economic model underestimate and unreasonably discount the costs

to the industry and to the registered non-prescription medicine sector in particular.

ASMI’s response explores the assumptions which underpin the RIS. ASMI believes the cost

to the registered non-prescription medicines sector is disproportionate to the risk arising

from that sector, particularly when considered relative to the likely benefit arising from this

medicine sector. By contrast the extent of change to prescription medicines and listed

medicines while also impacting every product is likely to be more straight-forward to

achieve and the cost of compliance more moderate.

Before the RIS is used to support this regulatory initiative, ASMI requests amendments to

the RIS assumptions, and therefore the costs to industry represented in this document, so

that it properly reflects the cost to industry of these significant medicine labelling changes.

Further ASMI believes the necessary changes to both TGO 79 and the RIS document are

sufficiently significant that the industry need to be given a further opportunity to confirm

the final proposal and its impact.

ASMI welcomes further collaboration with the TGA and will assist in any way necessary in

the development of a labelling Order that is consistent with the above-mentioned

principles.

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GENERAL OVERVIEW OF DRAFT THERAPEUTIC GOODS ORDER 79

ASMI appreciates the opportunity to provide comment on the TGA Medicine Labelling

Consultation, consisting of the draft Therapeutic Goods Order (TGO) 79, together with the

related guidelines and the Regulation Impact Statement (RIS).

About ASMI

ASMI is the peak body representing companies involved in the manufacture and distribution

of consumer health care products (non-prescription medicines) in Australia. ASMI also

represents related businesses providing support services to manufacturers, including

advertising, public relations, legal, statistical and regulatory consultants.

ASMI is committed to expanding and promoting Quality Use of Medicines (QUM), which is

central to the National Medicines Policy. The goal of QUM is to make the best possible use

of medicines by:

Selecting management options wisely

Choosing suitable medicines if a medicine is considered necessary

Using medicines safely and effectively.

Mechanisms and initiatives that are supported by ASMI that contribute to QUM include:

Development of criteria for consumer-focussed labelling,

Provision of information and education, in partnership with other key stakeholders

Setting standards for promotional activities via the ASMI Code of Practice and participation in the co-regulatory arrangements for promotion of OTC medicines.

QUM requires a partnership approach, a close collaboration between consumers,

healthcare professionals and other relevant stakeholders in a consultative manner.

ASMI believes that for non-prescription medicines, the label is the primary source of

information for consumers. Since consumers use non-prescription medicines as part of self-

care, with minimal supervision from healthcare professionals, labelling of non-prescription

medicines should be consumer focussed, easy for consumers to understand, make it easy

for consumers to select the appropriate product for their condition, and provide all of the

necessary information for them to use their medicine safely, know what is in the medicine,

and know when and from where to seek further advice. In many respects therefore, non-

prescription medicines are different to prescription medicines and to those used solely by

healthcare professionals as part of patient care. ASMI believes therefore that labelling

requirements should reflect this, and that there should be a risk-based approach that

differentiates between these different contexts of medicine use.

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Labelling of non-prescription medicines – General considerations

Non-prescription medicines are a diverse group of products ranging from very low risk

products, such as toothpastes, hand sanitising products, confectionery-type throat lozenges,

vitamins / minerals, to products such as cough and cold medicines, analgesics, antacids,

through to Schedule 3 medicines such as proton pump inhibitors (PPIs) and antivirals.

Despite these differences, there are some commonalities in labelling of these products.

Generally, they are mostly used by consumers in unsupervised situations. It is imperative

that the labelling therefore clearly conveys the following information:

The brand name and trademarks, many of which are very familiar to consumers and

have strong brand recognition.

The medicine’s uses. Consumers shop by “need state” in the grocery or pharmacy

front of shop environment. This might be for a pain reliever, cough relief product, an

antacid, a vitamin or mineral, an antifungal cream or an anti-allergy product. For the

consumer, this is vital information as they have only minimal knowledge of

pharmacology. The front of pack usually also conveys to consumers what the

medicine is for, and any specific product attributes that may be important to them,

such as “non-drowsy”, “once a day” or the type of dosage form, pack size, etc.

The product’s active ingredient(s). ASMI acknowledges that for some products this

may be difficult to find, and that some increase in prominence will be needed for

some medicines.

The dosage form.

How to use the medicine, warning statements, both mandatory and non-mandatory,

additional ingredient information, contact details of the sponsor, and other

information – e.g. how to open a package, storage information, etc.

Other mandatory information on the front of pack / main label – such as signal

headings.

Some medicines require additional safety information, required under other

legislation, e.g. large bottles of mouthwash or pressurised containers require the red

diamond denoting “flammable” contents, as per Dangerous Goods regulatory

requirements.

The barcode. For non-prescription products sold in the grocery environment,

truncated barcodes are not allowed. Packs must have the full sized barcodes to allow

reliable and fast scanning.

Unvarnished areas for printed / embossed batch number and expiry dates

ASMI has, in the past, participated in work to develop consumer focussed or performance

based labelling for non-prescription medicines. Following collaboration with the

Communications Research Institute of Australia, the Labelling Code of Practice was

published in 2004. This work included consumer testing protocols and developed principles

which have been adopted in labelling of many non-prescription medicines.

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ASMI participation in the Medicine Labelling Consultation process

ASMI has participated in the Medicine Labelling consultation and review process, by

informal meetings with the TGA as well as by representation on the External Reference

Group and providing information and advice to TGA when requested. ASMI also appreciates

the willingness of the TGA to meet with industry to clarify specific parts of the draft TGO 79

during this consultation process.

It is in the interests of consumers, healthcare professionals as well as industry to develop a

reasonable and practical Labelling Order which achieves the objectives of improving QUM

through labelling, and that can be easily implemented by industry without incurring

significant costs. It is also important that the Order has minimal impact on brands, many of

which are easily recognisable and familiar to consumers.

ASMI Position on the necessary objectives of TGO 79

In addition to being consumer focussed, TGO 79 should:

Be easy for industry to interpret, adopt and transition to from TGO 69

Avoid changes to packaging dimensions or components, or changes to the

manufacturing / packaging process or facilities – which may require increases in

capital expenditure

Cause minimal or no disruption to business, either by stock recalls or from the

opportunity costs of diverting staff from their normal roles

Not make compliance difficult, thus avoiding the need for Section 14 (S14)

exemptions on a regular or continuing basis. S14 exemptions should be confined to

exceptional circumstances and not used as a tool for addressing inability to comply

with the Labelling Order.

Be readily understood by both regulatory and non-regulatory personnel to facilitate

production of compliant labelling.

Result in minimum impact on branding or interference with trademarks

TGO 79 itself should be precise and use objective language. It should be clear, applicable to

the vast majority (if not all) product and packaging types. It should recognise the relative

risks of the various product categories covered by the Order and regulate accordingly. It

should not disadvantage sponsors currently marketing particular products.

ASMI acknowledges there are circumstances where exemptions under Section 14 of the

Therapeutic Goods Act (S14) are needed. However, these should not be used to address

inherent deficiencies within the Order. These do not provide business certainty. If the

criteria outlined above are met, then the need for S14 exemptions should be minimal.

ASMI notes that TGO69 may not have been perfect requires updating, however labelling

exemptions were relatively infrequent and compliance was achievable for the vast majority

of packaging types.

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Comments on the process for development of the draft TGO 79

Changes to labelling have been discussed for more than a decade, either as part of ANZTPA

or as updates to the Order. ASMI has provided comment throughout the process. We note

the following:

The 2012 consultation paper was poorly drafted, and proposed changes that would

have been very damaging to industry and difficult to achieve.

The tone of the 2012 consultation appeared to be confrontational towards industry,

rather than seeking to work collaboratively.

Since the publication of this consultation, ASMI has sought TGA advice on some concerns

that will be further elaborated in this response, and the TGA has been willing to meet and

engage with industry to clarify some of the issues and provide information on the intent of

some of the requirements in the draft TGO 79 consultation. ASMI appreciates the TGA’s

advice, however we must respond to the draft Order as published.

ASMI acknowledges the TGA’s stated position in relation to the labelling reforms that were

communicated to industry and agrees with these principles:

There is no intention to necessitate increases in packaging dimensions to

accommodate the requirements of the Order

There is no intention of incurring capital expenditure upgrades to labelling and

packaging lines, or changes to manufacturing sites to enable compliance with the

Order

There is a general view that Australia should harmonise to certain aspects of the UK

requirements “as practiced”

There should be some increase in prominence of active ingredients

Uniformity in back of pack presentation is desirable

There is no intention to interfere or cause an adverse impact on branding of non-

prescription medicines or trademarks for medicine names / designs.

This response provides comment on the draft TGO 79 and the Regulation Impact Statement

with the above agreed principles in mind.

General Comments on the draft TGO 79

ASMI believes that the draft Order as written is over-complicated, largely inconsistent with

the above principles and that substantial amendment is needed. There are many unresolved

issues in the draft Order and ASMI’s view is that it cannot proceed in its current form.

When considering the desired aims of the draft Order, it is likely that these could have been

met with some simple updates to the TGO 69 and some further differentiation between

product types, i.e. prescription, registered non-prescription or listed medicines. Instead, the

draft Order is complicated, conflates prescription and registered non-prescription medicines

by imposing nearly all of the same requirements other than the additional requirement for

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the Medicine Information Panel (MIP) on registered non-prescription medicines, and fails to

recognise that there is limited space on many medicine labels.

ASMI believes that the draft Order would be much easier to follow for all sponsors, both

prescription and non-prescription, if it was structured to include all general requirements

that are applicable to all medicine classes (e.g. as Part 1), followed by a section for

prescription medicines (e.g. as Part 2), a section for registered medicines not in S4 or S8 (e.g.

as Part 3, which should also include specific exclusions for registered complementary

medicines), followed by requirements for listed medicines (e.g. as Part 4), then information

on expression of active ingredients and Schedules, etc. This structure enables sponsors to

quickly identify the relevant sections or parts of the Order applicable to their particular

medicines, without the need to work through content irrelevant to their product.

More differentiation on the basis of risk is required. Ironically, the draft Order will have an

unnecessarily severe impact on some of the lowest risk goods, which may also happen to

have limited label space. Examples include throat lozenges and antacid roll wraps, small

containers for hand sanitisers and tubes of cream and toothpastes, many of which will need

to change packaging type or dimensions to accommodate the draft Order.

The combined requirement for an increase in active ingredient font size to the equivalent of

15 points Arial, combined with the formatting requirements of the MIP, has put pressure on

the majority of small packs, both bottles and cartons, and particularly affects products that

have three active ingredients.

The draft Order confusingly attempts to change the expression of active ingredients on the

main label. Consequently the possibility exists that multiple products with the same active

ingredient could express that active ingredient name and its quantity or proportion

differently on the label. This would be very confusing for consumers, especially for non-

prescription medicines where self-selection occurs, as well as for healthcare professionals.

ASMI suspects that this may be an unintended consequence of attempting to accommodate

the proposed increase in active ingredient prominence and the international harmonisation

of ingredient names, together with partial adoption of the UK practice, by allowing some

use of common names to truncate the wording on labelling.

Harmonising labelling requirements (or convergence) cannot be achieved by cherry picking

of guidelines or requirements from other jurisdictions. More consideration should be given

to how these will work in the Australian regulatory environment, as the new requirements

will become an additional feature of the existing regulatory environment that covers

registration/listing, scheduling, dangerous goods, etc.

Products unable to comply with the Order will be forced to either change their packaging

type or dimensions or format of labelling (e.g. to a concertina / peel-off label), all of which

costly propositions. The only alternative is to apply to TGA for a S14 exemption. There are

many parts of this draft TGO 79 where the final impact will be either of these two situations.

S14 exemptions do not provide business certainty as these are intended to be used for a

limited period. ASMI believes that the TGA would also find a large number of S14 exemption

applications to be resource intensive and impractical.

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ASMI has reviewed the draft Order in detail. The sections that follow include:

Detailed discussion of some specific concerns – Unique Australian requirements,

active ingredient prominence, the Medicines Information Panel, the need for

“intermediate OTC” or a special category of smaller non-prescription medicine labels

to be defined, expression of active ingredients

A detailed review of the draft TGO 79, together with a marked up version of the

draft TGO 79.

Proposals for amendments to draft TGO 79.

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DRAFT TGO 79 – SPECIFIC CONCERNS

Unique Australian Requirements vs alignment with international standards

TGA has previously stated in meetings with ASMI that rather than imposing the burden and

costs of consumer testing of individual labels onto sponsors, Australia should consider

labelling requirements adopted by some overseas countries that have comparable levels of

regulation. ASMI supports this principle and also notes that any overseas requirements

should be adapted for Australia and should complement existing regulatory requirements.

In previous discussions with ASMI, the TGA expressed the view that the active ingredient

prominence as implemented on UK labelling may be suitable for adoption in Australia.

While ASMI agrees with this view in principle, it should be noted that:

UK requirements are in the form of guidance, which is not the same as an Order and

is not a legislative instrument

The UK guidance does not specify any particular font size and refers only to

prominence and placement

The UK guidance is not prescriptive; thus there is flexibility to label different pack

sizes proportionately

The UK does not require signal headings, which can take up as significant proportion

of the main label space.

This differs markedly to the TGA’s prescriptive approach to font size and placement, which is

incorporated in a legislative instrument. The TGA’s interpretation of UK requirements has

resulted in a draft Order that results in very different labels to those which are in use in the

UK, and denies Australia the flexibility that exists in other markets.

Below are relevant excerpts relating to active ingredient prominence, from the labelling

requirements of other comparable jurisdictions:

Europe

The EU Directive 2001/83/EC (Article 56) states that active ingredients shall be “easily

legible, clearly comprehensible and indelible”.

UK – MHRA Best Practice Guidance on Labelling and Packaging of Medicines

The MHRA Best Practice document refers to the placement of the active ingredient name,

immediately following the name of the medicine on the pack, with no intervening text. It

allows use of the INN or the usual common name of the active, and states “Where the

common name appears after the brand name, it should be given due prominence. Generally

this will be determined by the relative size of the text but other factors may be relevant”.

Canada

The Health Canada “Guidance Document: Labelling of Pharmaceutical Drugs for Human Use”

refers to a specific size of active ingredient only for the Canadian category of official drugs.

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Otherwise, active ingredient font size for OTC medicines is discussed in terms of

prominence. There are some font size requirements for pack inserts and CMI.

General observations on overseas requirements, relating to active ingredient prominence

Other than the European Directive, the guidelines for the UK and Canada are guides to

facilitate compliance rather than inflexible and prescriptive requirements that all labels

must meet.

In the UK, there is some variation in active ingredient font size. Where there is a single

ingredient in many cases the font size may be on average, around 3 to 4 mm equivalent,

with no salt and no strength / quantity of the active ingredient shown on the main label.

However where there is more than one active ingredient, the name of the active ingredient

is in a much smaller font, around 2 mm (i.e. 8 point Arial equivalent), with no strength or

salt shown on the main label. Below are some examples of acceptable OTC labels in the UK:

Current UK Benylin Chesty main label:

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Current UK Sudafed Mucus Relief Triple Action main label:

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Active ingredient prominence and font size ASMI understands that the TGA has tried to adapt UK practice into a TGO. This is a difficult

exercise. The draft TGO 79 has proposed a “one size fits all” approach to active ingredient

prominence, i.e. the equivalent to 15 points Arial in any sans serif font. This does not reflect

UK practice, represents a unique Australian requirement and it will also have a significant

detrimental impact on some non-prescription medicine presentations, to be discussed

further below.

While ASMI understand that the TGA’s objective was to reflect “UK as practiced”, the draft

TGO 79 does not reflect UK practice and it imposes a more stringent and onerous approach

to labelling. Being a legislative instrument, the consequences of non-compliance are severe.

The draft TGO 79 states [Section 9(7)(a)], for registered medicines: “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 than the equivalent of 15 point Arial in any sans serif font”. This is

applicable to all labels, other than those of small (less than or equal to 25 mL capacity) or

very small (less than or equal to 2.5 mL capacity).

ASMI has the following concerns regarding the proposed letter height:

It is a significant increase compared to currently allowed letter height. It represents

more than two and a half times the currently allowed 1.5mm letter height

(expressed as ascender/descender). The proposed font size of “equivalent to points

Arial” is also difficult for compliance measurement within companies, particularly by

non-regulatory personnel and those in QA

This increased prominence can only be achieved at the expense of other

information which consumers, pharmacy assistants and pharmacists require when

selecting a non-prescription medicine. Examples are usage information, some claims

e.g. “sugar free”, “non-drowsy” or “once a day”, which provide important

information for consumers. It is vital that the increased prominence of actives does

not result in this information being removed from product labels

Only a proportion of OTC medicines, mainly those in larger packs or with single

ingredients would be able to comply. For the remainder, a S14 exemption is

required if the draft Order does not change. A large increase in volume of S14

applications is a predictable outcome, as is the change to packaging type or label

dimensions

It is a completely unachievable requirement for many OTC products that are

presented in smaller packaging types, smaller bottles, tubes, wrappers and

dispensers.

Products that contain more than two active ingredients would find it extremely

difficult to comply with the proposed font size.

Composite packs have not adequately been addressed – when there are two

formulations, each containing two active ingredients – is this regarded as being four

active ingredients?

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The proposed font size is not reflective of a risk based approach and has been

applied to all registered products – registered toothpastes, chewable antacid

tablets, registered complementary medicines, low risk OTC medicines as well as

prescription medicines.

The proposed International Harmonisation of Ingredient Names will have a great

impact on how the active ingredient names and quantity or proportion are

expressed. ASMI notes that the TGA has proposed some changes to how active

ingredient naming is to be expressed on labels, by allowing use of the free base/free

acid on the main label and the name of the salt on another part of the label. This is

discussed further under active ingredient expression. ASMI is concerned that this

approach to naming of active ingredients has been put forward as a way of allowing

for increased prominence by truncating the active ingredient name; this is not a

solution and presents some further concerns around possible consumer confusion

on non-prescription medicines.

Industry Examples – active ingredient prominence as per draft TGO 79

ASMI members have tested the proposed requirements in relation to active ingredient font

size and can offer the following specific comments and examples.

Active ingredient prominence diminishes the legibility of other important labelling

information

Consumers rely upon “need state” information when self-selecting a product. For example –

chesty cough, dry cough, sugar free, or other product attributes. Some of this information

can be very important, and some examples of the impact of the proposed TGO on other,

important information for consumers is shown below.

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Example 1 – Aqium Gel. The usage information “Antibacterial hand gel” blends into the

background compared to the active ingredient. Not only is this confusing to consumers, it

carries significant safety concerns as it may contribute to misuse. Other important

information such as “No rinse”, which is relevant to appropriate use of this product, is

diminished.

This is an example of labelling that would not facilitate quality use of medicines and may

even increase risk of misuse.

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Example 2 – Pinetarsol Solution. As seen in the example below, the information used by the

consumer to make a decision on purchase or to check that the product is suitable for their

condition, in this case “relieves inflamed and itchy skin” “pH 6.5”, “soap free cleansing

solution”, take a very subordinate position. This information is arguably more important to

the consumer in this case than the ingredients. For this product, the increased prominence

of active ingredients may even confuse consumers and some may think it is not even for

human use (pine tar).

Furthermore, the font size required does not achieve cohesiveness with the name of the

medicine as the active ingredient names and quantities cannot be presented on single lines

for each active. A smaller font size would in this case, achieve prominence, cohesiveness as

well as being more aesthetically designed.

Note also that the Medicines Information Panel does not fit on the label of this 100 mL

bottle.

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Example 3 – EgoPsoryl TA. This is an additional example of the product uses being

subordinate to the active ingredient, to the point where consumers may be worried and

confused about what a medicine with coal tar, phenol and sulfur could possibly be used for,

as the indications “an aid in the control of stable, moderate psoriasis and persistent

dermatitis” and “no preservative added” are barely visible.

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Example 4 – Gaviscon Pocket Pack. This is an example of a dispenser / pocket pack label for

an antacid product. Note that the claims “Effective Relief, Heartburn & Indigestion do not fit

on the label.

Example 5 – Cepacaine. In this example, the active ingredients fit on the label, however this

is not an appealing label design and the information that the consumer requires – such as

“rapid pain relief, for conditions of the mouth and throat” are harder to find on the label.

Again, the active ingredient statement “ethanol 15% w/v” shown prominently on the label

may unintentionally contribute to misuse. It is difficult to see how this main label could

enhance quality use of medicines.

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Example 6 – Resolve Nappy Rash Ointment is a combination of miconazole and zinc oxide,

used for fungally infected nappy rash. This would not be clearly evident when a consumer is

self-selecting this product, as most consumers would not know that miconazole is an anti-

fungal. They rely on the product indications and uses to guide them towards appropriate

selection of product. In this case, the indications and uses have almost disappeared from the

main label. Consumers may unintentionally use the product for uninfected nappy rash.

Again, this is not optimal labelling for a non-prescription medicine.

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Example 7 – Duro-Tuss Chesty Cough Liquid Forte is a well-known brand of cough medicine

which is currently supplied in a 100 mL bottle. Note below, that it has been necessary to

remove all of the indications and product attributes from the label in order to meet the

active ingredient prominence requirements of the draft Order. Additionally, there is

insufficient space for the Medicines Information Panel. This particular label is not

particularly small – it is 125 mm x 52 mm, and the product contains only two active

ingredients.

Note also – that the signal header size has been decreased and that the branding is actually

quite small compared to other medicines and the active ingredients.

Again, it is difficult to understand how this labelling could be considered an improvement

for consumers.

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Example 8 – The example below is for the same medicine, in a larger (200 mL) bottle.

Despite the increased size of the label dimensions to fit the 200 mL bottle, the product uses

and attributes are still unable to be accommodated on the label.

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Active ingredient prominence interfering with branding or trademarks

Draft TGO 79, as written, will have a profound impact on branding and trademarks unless

some clarifications and amendments are made.

The active ingredient font size, as required by section 9(7)(a), must be considered together

with the requirements for placement in section 9(3)(a) and 9(3)(b) – “The name of the

medicine and the name(s) of the active ingredient(s) must on the main label:

(a) Appear as a cohesive unit by placing the name, and quantity, of each active

ingredient together on separate lines of text immediately below the name of the

medicine; and

(b) Not be separated by any text or graphics, except where additional information is

required by paragraph 11(2)(j) or in relation to medicines contained in a composite

pack or a medicine kit”

Section 9(3)(a) states that the name of each active ingredient must be immediately below

the name of the medicine. For many medicines, this cannot be achieved without any impact

on branding or trademarks, as illustrated below.

Example 9 – Panadol Tablets. The white Panadol “beacon” is a registered global trademark.

While the words “Paracetamol 500mg” may technically fit, it interferes with the trademark

and the sponsor should have the option of placement in a space where the trademark is not

impacted.

26

Example 10 –Elevit Pregnancy vitamins. ASMI wishes to question the intent of section

9(3)(b) – Could the Elevit “butterfly”, which is part of the Elevit trademark, be impacted by

this requirement? Is the TGA’s intent to interfere in branding to this level? Will the three

images of a woman going through pregnancy and the words “Healthy Mum” “Healthy Baby”

no longer be able to be used? The TGA should clarify the subjective requirements proposed

by 9(3)(b).

27

Products with multiple active ingredients

Some products, particularly those which are supplied in cartons of reasonably large

dimensions, may be able to accommodate a font size of 15 point Arial, especially if they

have only one or two ingredients.

However, for products containing three active ingredients, this is problematic, as can be

seen in the example below where there is insufficient space to fit the ingredients and

strengths.

Example 11 – Sudafed Sinus + Pain + Cough Relief. This product is in a standard carton size

of approximately 110 mm x 65 mm, which could be considered a commonly used pack

dimension for a range of cold & flu and sinus products. This may be considered to be a

generously sized carton, however it cannot fit three active ingredients, at a 15 point Arial

equivalent font size, on the main panel.

This is not an isolated example and it is applicable to a large range of sinus, pain and allergy

products and cold & flu plus cough type products.

Note also in this example, there is very little additional information, which had it been

present, would not fit on the label.

28

Products in composite packs

There are concerns with the treatment of composite packs in the draft TGO 79. Firstly – one

of interpretation. Consider two formulations in the same pack, for example a Day & Night

pack, each formulation containing two and three active ingredients respectively. Does the

draft TGO 79 consider these to be a total of five active ingredients, therefore having the

option of including this information on the back of pack?

ASMI believes that a composite pack with two formulations and a total of five active

ingredients should be considered as being, for this example, five active ingredients.

Below is a mock-up on how the labelling of a composite pack would appear, drafted as per

the proposed TGO 79 if this interpretation is correct:

Example 12 – Composite pack (main label only) for Dimetapp PE Day & Night Cold & Flu. The

active ingredients would be located on the Medicines Information Panel in accordance with

Section 8(8)(b)

29

Example 12 (continued) – The same composite pack product, main label only, as currently

marketed with labelling requirements as per TGO 69:

ASMI’s view is that the current labelling is actually better for consumers. We believe that

sponsors should have the option of including the active ingredients on the front of pack in a

font size of the equivalent of 6 points Arial, OR to include the active ingredients in the MIP.

The Order should also require the active ingredient information to be either on the front, or

on the back, however it should not be mandatory to include it on both panels. Composite

packs may contain cautionary and warning information for at least three different active

ingredients, and for some of these products, fitting all of the statutory information on the

MIP may be challenging. It should not be a requirement to duplicate the information on the

main panel and then again on the back of the pack.

30

OTC medicines in packs not defined as small containers as per Section 10(14) and 10(15) of

the draft TGO 79 which have limited label space

Many registered non-prescription medicines (both complementary and OTC) are supplied in

containers that have limited label space, but do not meet the TGA’s definition of small or

very small containers.

Examples of these are below:

Example 13 – Quick Eze, a roll wrap of antacid chewable tablets

Note the size of the actual wrapper, top right in example 13. The active ingredients must be

on the main label in the equivalent of 15 points Arial, and physically cannot fit on the label

of this very low risk product (see the above box for the active ingredients).

The MIP will be discussed separately in this response, however it also cannot fit.

31

Example 14 – Panadol Children’s 1 month – 2 years. This is the outer carton (primary pack)

that encloses a small container (20 mL)

According to the draft TGO 79, this primary pack must be labelled in full compliance with

the Order. The outer carton / primary pack does not meet the TGA’s definition of a small

container.

It is however clear that the primary pack cannot accommodate an active ingredient font size

of the equivalent of 15 points Arial. The required size of the active ingredient name and

quantity or proportion means that the information cannot fit on one line [Section 9(3)(a)]

and runs off the edge of the carton.

As per the previous example – the MIP issues will be discussed separately however there is

great difficulty fitting all of the information. It is cramped, does not include the barcode and

there is no space for the TE seal.

32

Example 15 – Duro-Tuss Chesty Cough Forte Liquid is an example of a product in a 30 mL

bottle, which under the proposed Order is not classed as a “small container” or “very small

container” as per section 10(14) & 10(15). Below is the current label:

Example 15 (continued) – Compare the current label above with the version below, mocked

up in accordance with the proposed Order:

There is insufficient label space for the active ingredients with 15 point Arial font.

33

Example 16 – Strepsils Lozenges presented in a cylindrical tube. This example illustrates that

small tubes are unable to accommodate a font size of the equivalent to 15 points Arial

without incurring a significant reduction in brand name and product actions / indications.

Given that this is a medicated lozenge and a low risk medicine, the justification for

increasing the active ingredient at the expense of the brand name on any safety grounds is

dubious.

Note also the “overflow” of the information on the Medicines Information Panel above.

34

Example 17 – Advil Children’s chewable ibuprofen tablets. This container is enclosed in a

primary pack. It requires a Medicines Information Panel and the font size of equivalent to 15

points Arial for the active ingredient name and quantity / proportion. In this case, the

sponsor determined that the width of the label would need to increase by 66%, and the

length of the label by 3.5% in order to just accommodate the requirements proposed in the

draft TGO 79. Note also that the size of the main panel on the left has been shrunk to less

than 25% of the width in order to meet the proposed requirements.

35

Summary of ASMI concerns regarding Active Ingredient font size

As clearly seen from the examples shown above, the proposed font size of “the equivalent

to 15 points Arial in any sans serif font” is not achievable for many non-prescription

medicine product and label types. The above mock ups / examples are a small but indicative

selection of mock ups provided by ASMI members; they are “typical” of label dimensions for

many products. It is evident that the font size proposed by the TGA of the equivalent of 15

points Arial is unsuitable for a large number of products.

Given the volume and variety of product types that cannot be accommodated, ASMI

contends that S14 exemptions cannot be viewed as a solution to the problem and changes

to the draft Order are needed.

The draft TGO 79 should be amended so that the active ingredient name(s) and quantity /

proportion may be realistically accommodated on the majority of, if not all main labels. The

main labels of the following product presentations face particular difficulty in complying

with Section 9 in its entirety and in particular subsections (3) and (7):

Labels for bottles of under 150 to 200 mL capacity that are either “wrap around”, or

separate front (main) and back of bottle labels - Whilst 200 mL may not intuitively

sound like a label that will have difficulty, some products, e.g. Listerine mouthwash

or Eno powder have separate front and back labels that take up a smaller proportion

of the bottle surface area. This label presentation is part of their brand equity or

heritage.

Carton labels with a main label panel of less than approximately 60 cm2 to 75 cm2

(i.e. 6000 mm2 to 7500 mm2 per panel), particularly if the medicine has more than

one active ingredient or a long medicine name / brand name and sub-brand names

needed for differentiation of umbrella brands.

Products with more than two active ingredients, particularly when combined with

any of the abovementioned label dimensions. Unlike the UK, Australia will require

the strength or concentration of active and disclosure of the salt in most cases.

Primary packs that enclose small containers and very small containers, as these will

also be proportionately small or very small, i.e. likely to have a proportionately small

surface area available on the main label panel.

Irregular or unusually shaped containers, such as dispensers, pocket packs,

cylindrical or tapered tubes, roll wraps.

Also, consider that non-prescription medicines require also “non-statutory”

information, such as product uses and attributes to facilitate appropriate self-

selection by consumers.

36

ASMI proposals relating to active ingredient prominence

ASMI believes that the draft TGO 79 needs to be amended in order to accommodate

the majority of, if not all registered non-prescription medicine labels, both

complementary and OTC. These presentations include medicines in smaller cartons,

bottles with either wrap-around or separate main and back labels, dispensers,

cylinders, tubes, aerosols, as previously described.

ASMI proposes that when looking at font size, MIP, and other requirements – labels

could be considered on the basis of label surface area or available label space, rather

than only the capacity of a (bottle) container, which is the only exception from the

15 point font size required by the draft Order. This exception has no applicability to

cylinders, tubes, wrappers, cartons, or other forms of packaging and is very narrow

in its scope.

The simplest approach for amendment, with the least amount of complexity, is for

the TGA to allow a minimum font size achievable on all types and sizes of labelling of

non-prescription medicines. This should be set at not less than 8 points Arial, in any

sans-serif font.

Alternatively, the TGA could adopt a definition for a cut-off based on “available label

surface area”. ASMI believes that this is also a fair and reasonable way of looking at

the limitations of particular label types, and targets the smaller font size to those

products with the greatest available space limitations.

Based on some preliminary testing, ASMI recommends that a reasonable label space

cut-off point for an exception from the 15 point Arial requirement is “less than or

equal to 70 cm2”, i.e. 10 cm x 7 cm. These labels could be termed “intermediate non-

prescription medicine labels” and the font size of the active ingredient and strength /

concentration for these labels should be the equivalent to 8 points Arial in any sans

serif font. This can reasonably allow non-statutory information, and possibly up to

three active ingredients to be achieved on the main panel for the majority of labels.

For all other labels, which are larger than “intermediate”, a font size equivalent to

10 point Arial in any sans serif font is more easily adaptable to most other differently

sized or shaped containers and packaging types.

The above proposals still achieve a significant increase in active ingredient

prominence compared to current requirements.

ASMI members have done a little label testing, which has not been included as part of this

submission (in the interests of brevity) and the consensus among ASMI members is that:

Small cartons, tubes (both cylindrical and tapered), dispenser packs / pocket packs,

and bottle labels of bottles less than 200 mL (both separate and wrap around) are

likely to have a main label panel with an area of less than 70 cm2. Defining this as a

cut-off for the suggested “intermediate non-prescription medicine” labels and

requiring an equivalent to 8 points Arial font size would in ASMI’s view be realistic,

however further testing might be needed.

37

Products that contain up to three active ingredients could more easily include all of

the active ingredients on the main label under this proposal, on both the

“intermediate non-prescription medicine” labels (at 8 point Arial) and larger labels

(at 10 points Arial).

ASMI believes that these proposals would achieve increased prominence of active

ingredients while at the same time preserving brand identity and minimising the

requirement for consequential packaging changes.

ASMI Recommendations for change to the draft TGO 79

ASMI believes that the TGA should amend the Order to ensure that active ingredient names

and quantity / proportion can be accommodated on all types of labelling, consistent with its

stated commitments in relation to labelling reforms, namely to not necessitate changes to

packaging dimensions, not require changes to packaging lines, and to limit capital

expenditure requirements. Options for amendment are:

1. The least complex and easiest to implement approach is for the Order to set a

minimum font size of not less than the equivalent of 8 points Arial for all registered

non-prescription medicines which are not in small or very small containers, allowing

flexibility and proportionality to be achieved on labels.

OR

2. ASMI would also support, as an alternative, the adoption of an “intermediate non-

prescription medicine label,” defined as a label with an available surface area of less

than or equal to 70 cm2 with an active ingredient font size of the equivalent of 8

points Arial in any sans serif font. This would be a more complicated approach

however it would achieve the desired aim of accommodating active ingredient

names and quantity or proportion on the “difficult” forms of labelling and packaging

described earlier in this section.

3. For all other non-prescription medicines, the Order should be amended to allow an

active ingredient font size of the equivalent of 10 points Arial in any sans serif font.

ASMI is willing to collaborate with the TGA to explore or test these proposals further.

38

Medicines Information Panel – ASMI concerns

ASMI has supported in principle the development of a standardised approach to providing

information about registered OTC medicines on the back of pack. In ASMI’s response to the

TGA’s 2012 Labelling Consultation, ASMI stated that “the idea of a standardised Medicines

Information Panel (MIP) has some merit, however the details need to be properly developed.

Some flexibility needs to be incorporated and the designs must be based on the outcomes of

consumer testing”. ASMI continues to hold this view.

ASMI acknowledges that there has been some refinement of the MIP requirements in the

draft TGO 79, compared to the proposals that were outlined in the 2012 Medicine Labelling

Consultation and the first draft of the TGO 79 (2013), however some fundamental concerns

remain.

The TGA has based the MIP requirement on the US FDA requirements introduced in 1999.

Although this issue is addressed further in ASMI’s response to the RIS, the TGA has not

demonstrated that the MIP proposed in the draft TGO 79 performs as well as, or better

than, some of the currently used and tested back of pack labels that are currently used by

some sponsors. Many Australian labels for non-prescription medicines have been developed

as a result of consumer testing and sponsors have evidence to show that the labels perform

well from a consumer usability perspective.

The 2004 Labelling Code of Practice, which was developed following collaboration and

contribution from industry, consumers and the TGA, proposed some labelling design

principles that were based on and supported by evidence. Many sponsors have utilised

these principles to develop performance based labelling on some of their products. This

labelling has been consumer tested and performs well in accordance with testing protocols,

has approved by the TGA and is currently on pack for some marketed products. This

labelling has been consumer tested and performs well in accordance with testing protocols.

In some respects it could be considered a regressive step to adopt the TGA’s proposed MIP

format for these products.

ASMI believes that the MIP as described in the Order should be considered to be a set of

minimum formatting requirements for grouping and ordering information on the label, that

could be adopted by sponsors who do not wish to invest in or allocate resources to

development of performance based labelling. Sponsors who wish to develop and use

performance based labelling or other approaches, such as peel labels, fold-out labels, should

be provided the opportunity to have these alternate labelling formats and designs

considered by the TGA and approved for use on labelling. TGO 79 should not attempt to

restrict all sponsors to a basic set of requirements for the duration of the Order, and not

allow any departure from that. ASMI believes this would limit sponsors’ ability to invest in

continuing development and enhancement of labelling approaches and designs and that this

is not in the best interests of consumers.

The MIP as proposed also has other limitations.

39

It is difficult to accommodate on many labelling types – including but not limited to

wrap around bottle labels, bottle labels designed as separate front and back labels

with small dimensions, small cartons with limited space on each panel, roll wraps,

tubes, dispenser packs, and the primary packs which enclose small containers (which

are by nature also small). These pack sizes and types should be excluded from the

requirement for the MIP due to space constraints. For these packaging types, there

should be some requirement to group and order the information consistently,

however this could be done in a more flexible way, by avoiding duplication and

perhaps allowing smaller headings or other ways of accommodating the information.

Products with lengthy warning statements have difficulty accommodating all

required information. For these products that are required to present a considerable

amount of information on a small space, while maintaining a high level of clarity and

readability, performance based labelling design becomes even more important.

Examples include Day & Night packs and products that contain combinations of

ibuprofen or paracetamol with other medicines. Continuous improvement of label

designs should be encouraged rather than discouraged by the TGO.

The draft TGO 79 limits the information that is able to be included in the “Warnings”

section, only to warning statements required by the TGA, e.g. in RASML or in any

other standards, or required as a condition of registration or listing (see section 6,

Interpretations). It is unclear whether additional warning statements proposed by

sponsors – e.g. as part of global core data sheet updates – are allowed to be included

in this section. The interpretation of “warning statements” in section 6 of the draft

TGO 79 should be widened to include additional statements proposed by sponsors

for inclusion on labelling.

The example of a MIP format shown in Schedule 2 of the draft TGO 79 adds further

confusion with the placement of the warning statement “Do not exceed the

recommended dose” under the “Directions for use” heading. This statement,

required for paracetamol and ibuprofen and other NSAIDS, is a RASML statement

and in many cases required to be “grouped” with the other statements (i.e. it has an

additional [j] presentation requirement). This suggests that it should be included

under “Warnings”, and further illustrates sponsors’ difficulties in determining exact

categorisation and placement of currently applied warning statements within the

proposed MIP format.

The MIP is proposed for all registered non-prescription medicines. There should be

exemption for certain classes of products from requiring a MIP. Examples are

registered complementary medicines, hand sanitisers, simple antacids, and products

in roll wrap or cylindrical tube format, e.g. chewable tablets, lozenges.

Some labelling requires additional information that is not part of “Warning

statements” – such as dosage tables; instructions for opening a container or using a

measuring device; engaging a closure; cautionary graphics such as the red diamond

for flammable goods, and others. Some flexibility may be required at times for these

products.

40

It should be recognised that the back of pack also has space pressures, including the

requirement for the full sized barcode for scanning in the grocery environment.

Retailers do not accept goods without full sized barcodes. Some of these products

(particularly analgesics) also have very slim side panels that fit no more than the

brand name or contact details of the sponsor.

The USA and Canada require the MIP to be on the primary pack only, and it is not

required on the immediate container when it is enclosed in a primary pack. ASMI

does not support a unique Australian requirement of requiring the MIP on the

primary pack as well as the immediate container.

Below are some examples of labels that demonstrate some of these limitations more

clearly.

Non-superiority of proposed MIP compared to existing performance based back of pack

labels

Example 18 – An example of a current label that has been consumer tested and researched:

Current, tested back of pack labelling for a Dimetapp product. Note the use of visual cues

(ticks, crosses), grouping of information, shading, and spacing. We regret the poor

resolution, however despite this, the differences can clearly be seen.

Current, tested label:

41

Proposed, back of pack for the same product, as per draft TGO 79:

As can be seen from the above examples, the shading, grouping and use of visual cues

enhances the reader’s ability to quickly locate important information. The current label has

better readability than the TGA’s proposed MIP by use of colour, sub-headings that stand

out and more “white space” in the “Do not use” and “Ask your doctor before use” sections.

A specific concern is the presentation of information on contraindications and precautions.

Currently, these labels use the headings “Do not use” as “Ask your doctor before use”, in a

clearly and prominently. These headings are action-based, i.e. tell the consumer what to do.

In contrast, the statement “Warning” implies generic warning information for the consumer

rather than an action based statement, which might be more easily overlooked by

consumers. In the model proposed by the draft TGO 79, this information is presented under

“Warnings” as a big group, separated by a hairline, and it is likely that it is more difficult for

a consumer to quickly locate or notice if they are not specifically searching for the

information.

We believe that this reduces, rather than enhances readability. ASMI does not believe that

the TGA has demonstrated superiority of its format over the performance based designs.

This should not be considered to be an isolated example.

42

Example 19 - for Panadol with Optizorb.

Note that there are similarities, but the

headings are more clearly visible with

more white space on the label, which

improves readability. NB - These are same

sized packs but appear different due to

scale of pdf used. TBC

Current label (below)

Proposed label as per TGO 79

43

Suitability of MIP for small labels – including small labels on larger containers not defined as

small containers under Sections 10(14) & 10(15) of the draft TGO 79.

Example 20 – Eno back of pack – MIP is unable to be accommodated:

The information shown above “Other information” and the contact details of the sponsor

cannot fit on the MIP shown above. NB – This example is shown for sizing purposes only – it has

not been drawn up in the recommended black on white.

44

The current Eno back of pack is shown below. All required information is able to be

accommodated on the label; the current label shows the information grouped into sections,

with sub-headings and separated.

This labelling style, i.e. a small label – either wrap around or separate, is not uncommon and is

used on products such as Eno and Listerine, therapeutic shampoos, and other products such as

the head lice product below.

45

Example 21 - Moov Head Lice Solution bottle labels. Please note the rear bottle label unable to

accommodate the MIP. The bottle is a 200 mL bottle, but it has separate front and back labels,

similarly to the Eno example shown previously. In this case, the label is rectangular to fit the

dimensions of the bottle. This product has lengthy directions for use due to the nature of the

product, thus some other information (shown under the label) has difficulty fitting. This

product is a registered complementary medicine. Some listed products contain the same

ingredients and make similar claims; the listed products will not be required to include a MIP.

46

Example 22 - Aerius for Children 60 mL bottle. Note that it is impossible to fit the MIP on this

container. The narrow strip on the left, containing Batch number and expiry date together with

the QR code for scanning on the packaging line cannot be diminished further. The main panel

also cannot be diminished any further. The only suitable approach to alleviate the problem is

for the MIP to not be required on the immediate container if it is on the carton, or to allow a

truncated MIP. (NB: We note that the active ingredient is included twice on the main panel in

error; this does not have an impact on available space for the MIP as the main panel cannot be

diminished any further).

47

Example 23: Aqium. This is a hand sanitiser, a low risk product. The MIP cannot fit on the 70 mL

pack size.

48

Example 24 – Quick-Eze is a low risk antacid in a roll wrap. The MIP cannot fit in the available

label space:

49

ASMI proposals for changes to MIP requirements

ASMI acknowledges that some initial concerns have been addressed in the draft TGO 79. These

include the ability to continue the information over more than one panel if there is insufficient

space, as well as allowing the use of colour for headings.

However, further amendments to section 10(20) are required:

The MIP should be considered to be a basic set of requirements for grouping and ordering of

information in the absence of label testing, and the Order should set “minimum requirements”.

ASMI believes that the Order should not include design requirements, such as left justified

headings, black on white, or inflexible ordering of information. Design elements should be part

of the guidance document rather than the Order, and there should be some flexibility allowed

for sponsors to best fit the information to their product labels.

The MIP should be allowed to be truncated or amended, if space does not permit. Examples

are: Removal of “Medicine Information” heading; removal of “ingredients” heading and active

ingredient information if it is present on the main label; removal of “uses” if these are shown

on the main label.

If an additional category of “intermediate non-prescription medicine labels” (as proposed

earlier in this response) is developed in addition to the exceptions for small containers and very

small containers in sections 10(14) and 10(15), these labels should have the option of using

truncated or amended MIP to fit their labels. The definition of “intermediate non-prescription

medicine labels” should be developed collaboratively with industry.

The definition of “Warnings” should be expanded to allow additional warning statements

requested by sponsors that are not in RASML or a TGA standard, so that these may be added to

the “Warnings” section of the MIP rather than included as “Other information”. There are

many warning statements within RASML, not all of which fit neatly under the “Warnings”

section and format shown in Schedule 2 of the draft TGO 79. ASMI believes that as sponsors

start looking at their labelling and considering placement, more issues will arise with grouping

and wording.

Some very low risk products (examples are hand sanitisers, toothpastes, roll wrap antacids)

should not require a MIP as there is no evidence that the MIP is needed for these products.

The TGA should consider allowing departure from the MIP for sponsors who wish to develop

and test performance based or alternative labelling formats as part of ongoing label

development. The Order should not seek to limit continuous improvement of labelling.

The Order should include only the basic, minimum requirements for grouping of information

and the requirement to include this grouped information on the label. All other requirements

regarding design features and order of information should be in the guideline. This will allow

sponsors to best fit the information on the pack, when facing the challenges of product types

with limited label space, particular packaging types (such as tubes, dispensers) and other

inflexible requirements such as barcodes and QR codes for packaging lines. This will also the

TGA to consider and evaluate applications from sponsors with performance tested labelling or

alternative label formats.

50

ASMI continues to support the US and Canadian position, that the MIP should be required on

the primary pack only (not on the immediate container if it is enclosed in a primary pack).

51

Impact on products within a range

The draft TGO 79 has not considered the products within a branded range or family of brands.

For these products, the design and graphics are important as these facilitate product

differentiation.

While a large increase in prominence may be achievable for particular products within a range

(e.g. those in larger packs), this may not be achievable for the entire range, and the

consequence of this is disruption to the brand architecture.

The example provided below for a well-established TGA approved brand range, illustrates this

clearly:

In this instance, the sponsor has clearly differentiated the products within the range by use of

colour and design features, such as the differently coloured “boxes” or “flags” to differentiate

the brand variants. This is important in assisting pharmacists, pharmacy assistants and

consumers with product selection and for the different product variants to stand out on the

shelf.

The impact of an unachievably large active ingredient prominence is that the brand design

must change for certain products within the range in order to accommodate the increased size

of the active(s). This inconsistency is problematic. The range will lose aspects of design that are

important and some products within the range will depart from the brand architecture.

Using the Bisolvon range as an example - While the 200 mL bottles may be able to achieve an

increase in prominence of the active ingredient on the main label of the carton (primary pack),

this is not achievable for the container label, with the result that the brand design becomes

inconsistent between the primary pack and the container label. Note the red “Chesty Forte”

colour box that is an integral part of the brand architecture has had to be changed, and there is

a departure from the unified look of the product range. The result is that the bottle and

primary pack will have different designs.

52

Bisolvon Chesty Forte container label mock-up :

The range also includes tablets in a small carton. In this particular case only, there is one active

ingredient, so it is physically possible to achieve an increase in prominence for the single

ingredient. However the consequence of this is that the brand architecture is disrupted, and as

for the liquid example above, different products within the range will have different looking

labelling. Similarly to the container label, the colour box is lost:

Bisolvon Chesty Forte tablets carton mock-up

NB: This has been cut from a pdf so it is not to scale in mm, however the original pdf was to scale.

The example below shows the same carton, with an active ingredient font size of equivalent to

8 points Arial:

53

In this particular example, 8 points Arial is the largest font that can be achieved without causing

adverse impact on the branding design that is used across the range. This will allow all variants

within the range to retain the design features currently used and maintain the differentiation

across the range.

ASMI believes that the draft TGO 79 has not sufficiently considered the particular requirements

of products that fit within a brand range or family of brands. These are:

The need to maintain a consistent brand identity or brand architecture across a range of

different variants

The presence of different dosage forms and pack sizes across the range

The layout of the name and variant needs to be consistent across the range for all

products

Some products have long names featuring sub-brands.

There is also a requirement to clearly state the different indications and product

attributes to avoid consumer and pharmacist / pharmacy assistant confusion.

The above is a single example out of many currently marketed, TGA approved and well-known

brand ranges or families. The issues raised above are not isolated to this example and apply to

many products, for which consistency across the range, together with differentiation within the

range are important features for both consumers and health care professionals.

ASMI believes that the most appropriate approach is therefore for the Order to set a minimum

font size that can be adopted across a range without the need to re-design brand architecture

or make changes to the design of certain variants within a range.

Mock-ups that have been done by ASMI members indicate that an 8 point font size is the cut-

off point at which increased prominence of active ingredients can be achieved without

adversely impacting on brand designs within a range, as it can be accommodated on the

majority of differently sized carton labels and container labels. This will avoid the potential

situation of container labels being different to primary pack labels or carton labels.

The TGA, when evaluating labelling, is increasingly looking at brand architecture across a

product range and imposing an unachievably large font size will mean that it can only be

applied for specific products within that range, thus adversely impacting sponsors’ ability to

retain their brand identity and differentiation.

54

ASMI RECOMMENDATIONS FOR AMENDING TGO 79

Active ingredient font size and MIP

The preceding sections on active ingredient font size and the Medicines Information Panel

(MIP) have demonstrated that the increase in prominence of active ingredients on labelling,

together with the MIP present a challenge and are unable to be accommodated on all

registered non-prescription medicines.

In relation to non-prescription medicines, the draft TGO 79 proposes:

For registered medicines - a minimum font size of equivalent to 15 points Arial in any

sans serif font, unless the section (10)(14) or (10)(15) applies

For registered non-prescription medicines that have a MIP and when there are 4 or

more ingredients, these may be declared on the back of pack, or another label panel

For products in small containers, less than or equal to 25 mL capacity, the active

ingredient must be in a font size equivalent to 8 points Arial; the strength must be

equivalent to 6 points Arial in any sans-serif font

For very small containers, less than or equal to 2.5 mL capacity, the active ingredient

must be equivalent to 6 points Arial in any sans serif font; the strength must be

equivalent to 4 points Arial in any sans serif font

For listed medicines, active ingredients and strengths must be equivalent to 6 points

Arial in any sans-serif font

As has been clearly shown, together with worked up examples, there are factors that apply to

non-prescription registered medicines, both complementary and OTC, which make the font

sizes proposed by the draft TGO 79 difficult if not impossible to accommodate without either

increasing carton / container dimensions, or significantly affecting the size of branding or

intruding onto registered trademarks. In addition, OTC medicines require consumer oriented

information on the front of pack, to convey information that is important to consumers when

choosing medicines. The following additional information (statutory and non-statutory) is

almost always included on the main label of a non-prescription medicine

Branding information, brand logos, brand design or trademarks. These may assist with

differentiation, particularly in the case of umbrella brands, and in some cases the

names of umbrella branded products are quite lengthy

Signal headers and SUSMP requirements

Information on what the product is used for – if there are multiple ingredients, this

may be quite comprehensive

Generic product information, e.g. “anti-inflammatory” “anti-fungal” etc.

Additional descriptors for the dosage form and description (may be a graphic, in the

case of day & night)

Flavours, or colours

55

Other information – such as “sugar free”, whether a measure is included, graphics to

assist consumers with limited literacy, etc.

The amount and type of information required on a prescription medicine is therefore very

different to that needed on a non-prescription medicine. Non-prescription medicines also

include information that is important to consumers, such as the medicine uses and attributes

on the front of pack / main label; this information is particularly important for consumers when

self-selecting medicines.

The Medicine Information Panel has also been introduced as part of the draft Order, to

introduce consistency in grouping and ordering of information. ASMI supports consistency and

grouping, on the provision that enough flexibility is shown to allow the information to be

accommodated on as many types of packaging as possible without the need for S14

exemptions.

It is therefore evident that the draft TGO 79, by making exclusion provisions only for listed

medicines and “small containers” or “very small containers” has essentially applied an active

ingredient size of equivalent to 15 points Arial as a “one size fits all” for both prescription and

non-prescription registered medicines, without considering the specific requirements of non-

prescription medicines.

ASMI believes that this is unachievable, and requires change to acknowledge the particular

information requirements on the main label of non-prescription medicines and the additional

space requirements for the MIP.

ASMI believes that the Order should seek to apply a minimum font size that is achievable on all

packaging types. The easiest and least complicated way of achieving this is to apply a smaller

font size for all registered non-prescription medicines that is capable of being achieved on

practically all product types and label sizes.

ASMI therefore recommends a minimum font size of the equivalent of 8 points Arial in any

sans-serif font, for all registered non-prescription medicines.

This achieves an increase in prominence compared to the TGO 69 and we believe this should be

achievable on practically all labels, including for products with three active ingredients on the

main label. Further testing is required to confirm this.

As an alternative, ASMI would also find acceptable an approach of differentiating font size

requirements based on available label space of the main label. This approach has the

disadvantage of introducing more complexity to the Order by creating a third and fourth

category of exclusions for non-prescription medicines. It may also be a little more difficult to

apply consistently across all products within an umbrella branded range.

In considering the various options, it was decided that surface area of the main label, rather

than capacity of a container, could be a suitable approach for the following reasons:

It is not limited to bottles

56

It considers both wrap around labels as well as separate front and back labels

It considers cylinders, tubes, dispensers, and small cartons (e.g. for 2s packs, 12s packs,

pocket packs)

It achieves increased active ingredient prominence compared to status quo

It allows some level of consistency in allowing an abridged MIP if needed

It allows sponsors to easily measure their labels to determine requirements

ASMI therefore recommends that the TGA consider either of the following approaches to active

ingredient font size for the main label:

For all registered non-prescription medicines (including registered complementary medicines:

Retain active ingredient font size proposed in the draft TGO 79 for small and very small

containers [section (10)(14) & (10)(15)]

Allow a minimum font size of equivalent to 8 points Arial in any sans serif font, as a

minimum requirement for all registered non-prescription medicines.

OR

As an alternative, a more complicated approach of introducing an “intermediate sized label for

non-prescription medicines” category and an “all other non-prescription medicines” category

could be looked at, as described below:

TGA could consider an additional category of “intermediate registered non-prescription

medicine” or “intermediate sized label”, which should be defined as less than or equal

to 70cm2 for the main panel.

For this category, the recommended font size for active ingredient and strength should

be the equivalent to 8 points Arial in any sans serif font, and an abridged or truncated

MIP should be allowed.

For all other registered non-prescription medicines, an active ingredient font size of

equivalent to 10 points Arial in any sans-serif font, unless Section 10(14) or 10(15)

apply.

57

Summary Table of ASMI recommendations

1. ASMI Preferred approach:

Description of pack or label type

Active ingredient / strength font size

MIP*

Very small container Section (10)(15)

6 point / 4 point No

Small container Section (10)(14)

8 point / 6 point No

ASMI Preferred approach: All registered non-prescription medicines that are not small containers or very small containers [as per 10(14) or 10(15)]

8 point / 8 point

Yes. Minimum requirements only should be in the Order. Flexibility should allow for: Truncated or abbreviated MIP by - removal of duplicated information, rationalisation of sub-headings; grouping of information under sub-headings required; minor change to order of information if this achieves a better fit or placement of information where label space is insufficient or where barcodes and TE seals may interfere with placement.

The above approach is simple. It sets a minimum requirement, allows consistency within

product ranges and gives flexibility to sponsors to adjust font size across label types.

It will achieve an increase in font size compared to TGO 69, and will allow the objectives of

minimal impact on branding and packaging or labelling type or dimensions.

58

2. ASMI Alternative approach:

Small container and very small container requirements as above (unchanged)

ASMI alternative approach Intermediate label for non-prescription medicines: Main label panel 70 cm2 or less irrespective of whether it is on a tube, bottle label, dispenser, or carton. Unless 10(14) or 10(15) apply.

8 point / 8 point

Yes. Minimum requirements only should be in the Order. Flexibility should allow for: Truncated or abbreviated MIP by - removal of duplicated information, rationalisation of sub-headings; grouping of information under sub-headings required; minor change to order of information if this achieves a better fit or placement of information where label space is insufficient or where barcodes and TE seals may interfere with placement.

Other labels Section (9)(7)(a)

10 point / 10 point MIP required

*ASMI believes that the MIP should be required only on the primary pack, and its inclusion on

container labels within a primary pack should be optional

59

PART 2 - SECTION BY SECTION DETAILED REVIEW OF DRAFT TGO 79

60

DETAILED REVIEW OF DRAFT TGO 79

Section Line

(TGA

original

draft)

Description Comment Proposal

General Comment Sponsor companies have provided feedback that:

The order is complicated and difficult to read;

When looking for requirements that apply to a specific

medicine, it is necessary to read through many pages of

text and sort through irrelevant information

The TGA could perhaps look at simplifying the

document by having all of the requirements

that apply to prescription medicines, registered

non-prescription medicines and listed non-

prescription medicines separately.

If this is too difficult, at least some form of

sorting should take place, so that the most

general and widely applicable sections such as

blister an strip packs, individually wrapped

goods, the MIP, small containers and very small

containers appear before injections, peritoneal

dialysis solutions, etc.

Some consideration should be given to making

the document more easily readable.

61

Introduction 49 – 52

And

68 - 73

Discussion on

QUM for labelling

Prescription and non-prescription medicines are

supplied within different contexts and therefore

labelling should take these differences into

consideration. Although it can be stated, on a basic

level, that “medicines are medicines”, this very basic

statement fails to consider the context within which

these medicines are used and the needs of consumers

when using non-prescription medicines (as opposed to

using prescribed medicines).

Non-prescription medicines are often self-selected by consumers and the label of a non-prescription medicine has special requirements that can assist consumers in selecting the right medicine and using it correctly. Consideration could also be given to structuring the draft TGO 79 in a different way, by including separate sections for prescription, registered non-prescription and listed medicines. This might help simplify what is a complex document.

ASMI requests further differentiation between

requirements for prescription and non-

prescription registered medicines.

This should include consideration of decreasing

active ingredient font size in general and

allowing more flexibility for the Medicines

Information Panel (MIP), in particular for

smaller cartons, OTC medicine bottle labels,

cylinders, tubes, roll wraps which will all have

difficulty accommodating the required

information due to physical limitations of

container / primary pack label size as well as

the space required to properly display non-

statutory, consumer required information on

the main label.

These matters are discussed in more detail in

the relevant parts of this response.

62

Transition

Arrangements

Section 4

Transition

arrangements and

commencement

of Order

ASMI supports a 5 year transition period, i.e. 1st

January 2020. We believe that the RIS has heavily

discounted the cost impact for implementation of the

draft Order. As explained further in ASMI’s response to

the RIS and the proposed draft TGO 79, if left

unchanged the Order will not be able to be

accommodated on a significant number of packaging

types and it will result in significant applications for

labelling exemptions under S14, as well as increases in

packaging dimensions, the need to place some

containers into cartons as well as a range of other

issues.

Other issues include the potential impact on branding

and trademarks, which will result from the

implementation of the draft Order if left unchanged

and has not been quantified. Consumer confusion as a

result of removing or severely diminishing non-

statutory labelling information will be a consequence of

an unchanged draft TGO 79 and it has not been

considered by the TGA.

ASMI believes that there should be no requirement to

do multiple updates to labelling as a result of, for

example, RASML updates, the NSAIDs review, or any

changes to ingredient names following on from the

international harmonisation of ingredient names

project.

ASMI requests commencement of 1 January

2020 – 5 years transition time.

The TGA should be realistic about providing

exemptions for labelling that cannot

accommodate the requirements.

63

Some member companies are undergoing integration

activities and mergers. These commercial activities will

require mass labelling changes and it is in the interests

of sponsors to be able to implement a single set of

changes.

TGA should be realistic and either extend transition

timeframe or be prepared to acknowledge that for

some sponsors this may not be achievable and be

realistic about allowing exemptions.

Section 6

Interpretation

180 Active Ingredient We note that there is also a definition for name of

active ingredient in this Order. This is as per TGO 69,

and we have no concern with the introduction of these

definitions, however we note that in some sections,

e.g. section 8.1, the wrong terminology is marked in

italics which then leads to the wrong interpretation.

The document should be thoroughly checked for

accuracy and consistency with its use and cross

referencing of the interpretations.

TGA should check the Order to ensure that the

correct terms are bolded in the draft Order, and

that they cross reference to the correct

definitions.

64

Section 6

Interpretation

222 delivered dose As written, the definition of delivered dose excludes pressurised metered dose products that are not inhaled, as well as other metered dose products, e.g. nasal sprays, mouth sprays, etc. If the intention is for these to be captured under the definition, then the definition should be widened. Please see also line 1278, which refers to other metered dose formats, and a check is needed as to whether these should be consistent.

A consistency check is needed, and

consideration of whether the definition of

delivered dose should include other dosage

forms.

Section 6

Interpretation

236 durable ASMI notes that the TGO 69 does not have a definition of durable, but in section 3(1)(b) refers to the requirement for the particulars of the Order to be clearly visible and must be written in “durable and legible characters”. The draft TGO 79 refers to the label itself, rather than the particulars on it. A problem arises when “durable” becomes a requirement in relation to certain forms of packaging, which must be torn to access the contents. For example roll wraps (for lozenges, chewable tablets, cough drops), sealed bags (containing lozenges), and backing boards (containing a blister for a lip balm sunscreen) – see section 7(3)(a) and (b).

ASMI recommends the TGO 69 use of the word

durable be retained. This would also be

consistent with its use in the Poisons Standard.

Section 7(3)(a) and (b) should be amended so as

to specifically not impact roll wraps, bags,

backing boards.

65

Section 6

Interpretation

296 label ASMI notes that there has been a fundamental change to the definition of label compared to TGO 69. TGO 69 defines a label as a “display of printed information upon, or securely affixed to, the container and any primary pack of the goods”. The proposed definition in the draft TGO 69 has removed the word “securely” and refers only to “affixed to”. ASMI questions why there was a need to amend the previous definition by removing the word “securely”. The change has been made with no explanation and represents a fairly fundamental change to the definition.

Retain TGO 69 definition of label

Section 6

Interpretation

319 Name and

contact details

ASMI requires some clarification with respect to how this definition will be applied. The TGA stated (in meetings with industry) that it would be sufficient for sponsors to include the sponsor name plus either the address, or email address, or telephone number (eg freecall number). This definition requires re-wording to make it clearer.

Suggested re-wording of definition:

“sufficient information about the sponsor or

supplier, whether by reason of the inclusion of

the sponsor’s or supplier’s street address of its

registered place of business in Australia (not

being a post office address), or an email address

or a telephone number, to allow it to be

identified so as to facilitate public contact on

matters of complaint, use or general enquiry;

66

Section 6

Interpretation

339 Name of the

dosage form

ASMI questions whether sponsors will have any flexibility with wording of dosage form names under the proposed definition. The TGO 69 definition refers to the “usual name of the pharmaceutical form”. ASMI questions whether sponsors will be able to state “oral liquid” or “liquid filled capsules” or “soft capsules” or whether the label will be required to state (for example) “oral liquid – suspension”, “capsule, soft”; “tablet, hard” etc.

Definition should be amended to allow

sponsors to refer to part of the AAN definition,

particularly where the dosage form has long

descriptors or is not in consumer friendly

language.

67

Section 6

Interpretation

326 Name of an active

ingredient

The draft Order requires that the active ingredient name is the name included in the AAN. ASMI has no concern inherently, however once the International Harmonisation of Ingredient Names requirements are adopted and international names are harmonised, some medicine names will include hydrates and solvates and will become too lengthy for inclusion on labels. TGA has looked to clarifying this situation in the draft guidelines, by allowing use of “common names” or free acid /base name on labelling, however ASMI has continuing concerns with the proposals outlined in the guideline, particularly regarding:

Whether there will be increasing inconsistency among naming of actives

Possible consumer confusion with the naming recommendations and strengths

Potential for labels that choose to show salts having different labelled strengths to those which do not (despite it being the same active/strength).

Will labelling changes be needed once a new salt is approved by TGA

Potential for products to select how to express the strength to allow the product to “look stronger” to consumers.

ASMI believes that the issue of naming and expression requires further thought and careful consideration prior to being adopted in the Order. Although the UK uses common names on the main label, there is less confusion because the strength is not included. Since the strength is needed on the label, there is possibility

ASMI recommends that the TGA does some

further work to clarify the active ingredient

naming conventions. Further industry

consultation is needed.

ASMI members have expressed a preference for

status quo with respect to naming, i.e. declaring

salts on labels. However, some labels in future

may require salts and hydrates/solvates, but

ASMI does not believe it should be necessary to

include the hydrate or solvate. Example:

Current label: dextromethorphan hydrobromide

Proposed (under IHIN) dextromethorphan

hydrobromide monohydrate

ASMI prefers current naming conventions be

retained for consistency and to minimise

confusion for consumers.

68

of inconsistent strength information to appear on labels. ASMI therefore prefers the existing naming conventions to be retained.

Section 6

Interpretation

345 Name of the

medicine

ASMI notes that the proposed definition of Name of the medicine refers to in part (a)(iii), the dosage form, and (a)(vii) flavour descriptors, with the condition “except where this is integral to differentiate medicines from other medicines” ASMI is concerned that inclusion of dosage form and flavour in the medicine name may result in some unintended consequences including:

Restrictions being placed on how the flavour can be displayed on the label, particularly when this is read in conjunction with section 9(2). Our interpretation is that flavours will not be able to be displayed on pack as a starburst, or on another part of the label, e.g. together with a graphic, and must be displayed “in a continuous uninterrupted manner and not be broken up with additional information / graphics. ASMI feels that this is unduly restrictive and seeks to enforce design principles. Many of the products affected are low risk goods such as lozenges and dissolvable vitamin products.

For blister pack and strip labelling, the dosage form and

TGA should clarify and amend wording to

enable

Sponsors of non-prescription medicines to

use generic foils for medicines with the

same name but different dosage forms (e.g.

Nurofen ibuprofen 200mg tablets, capsules,

capsule shaped tablet, soft gel capsule

should be able to use a generic “Nurofen

ibuprofen 200 mg” foil.

Sponsors of non-prescription medicines

should have the flexibility to display

flavours of a product within a starburst or

other graphic feature, not necessarily as

part of the name in a continuous

uninterrupted manner.

69

Section 6

Interpretation

407 Small container ASMI does not object to the definition for small

container included in the draft TGO 79. However, this is

a very narrow definition that does not consider other

packaging types that have small dimensions and

different weight measurements, particularly in relation

to non-prescription medicines that are required to

include much more consumer related information

(such as the MIP) on the label.

ASMI therefore proposes that an additional definition

of “intermediate non-prescription medicine label” be

included, that takes into account the available surface

area of the main label panel that can be applied to

bottles, cartons, dispensers, tubes etc. There are a

variety of non-prescription medicine sizes and packs

that are too small to accommodate the Order as

written and for these, some allowances will need to be

made.

ASMI proposes an additional definition of

intermediate sized non-prescription medicine

label that has realistic active ingredient font

size requirements and allowance for abridged

or re-formatted MIP. This is discussed in more

detail elsewhere in this submission.

70

Section 6

Interpretation

415 Starter pack ASMI queries the definition of starter pack. This

definition appears to be related to prescription

medicines, however it should be made very specific

that it pertains only to prescription medicine. Some

OTCs have starter packs or sample packs, and given the

nature of these products (able to be self-selected by

consumers or recommended by the pharmacist;

doctor’s prescription is not needed) there is no reason

to limit sample packs or starter packs to 1/3 of the

trade pack size. “Trade pack” isn’t defined either –

ASMI queries the meaning of this term, i.e. does it

mean that the product is on the ARTG? Or that it is

supplied in the market?

ASMI believes that for OTC medicines this is a

commercial issue not a regulatory issue.

Non-prescription medicines should be

specifically excluded from the definition of

starter pack.

Section 6

Interpretation

TBD TBD Some ASMI member companies have concerns that the measurement in “points Arial” makes compliance checking difficult and will require sponsors to develop templates and transparencies to enable compliance checking within the Regulatory / Quality functions; we request the TGA consider including an equivalence measurement.

ASMI suggests that the Interpretation section

should include an equivalence to “points Arial”

to enable easier compliance checking within

sponsor companies, e.g. “6 points Arial is

equivalent to 1.5mm ascender / descender or

capital letter height” etc.

Section 6

Interpretation

TBD TBD ASMI suggests that the TGA should collaborate with industry to agree on a definition for an “intermediate non-prescription medicine label” definition.

ASMI has suggested a definition based on

available surface area of the main label panel.

71

Section 7

General

Requirements

436 Section 7(1) –

intermediate

packaging

Section 7(1) refers to “intermediate packaging” – this requirement should apply to non-transparent intermediate packaging only. This is covered in 8(2) but could also be specified in 7(1) to make the requirements clearer.

ASMI recommends clarification and check for

consistency

Section 7

General

Requirements

443 Section 7(2)(d) –

font size

Section 7(2)(d) states “Unless otherwise specified, be displayed in text size of nlt the equivalent of 6 point Arial”. ASMI suggests that “in any sans serif font” should be added.

TGA should add “in any sans-serif font” to

section 7(2)(d)

Section 7

General

Requirements

445 Section 7(2)(e) –

contrast

Section 7(2)(e) should be amended to specifically allow for embossing and de-bossing. As written, the requirement for colour contrast. ASMI also questions how the TGA intends to measure “contrast”. The TGO will be a legislative instrument and certainty and objectivity is required for interpretation. Given the subjective nature of this requirement, ASMI suggests that it should be moved to a guideline.

Add “except when embossed or de-bossed” to

section 7(2)(e).

This section should be in a guideline.

72

Section 7

General

Requirements

448 Section 7(3)(a)

and (b) durable

This section has significant impact on low-risk products packed in roll wraps or bags, for products like cough drops and chewable antacid tablets, and products enclosed in a backing board. There is no safety justification for this requirement in relation to this group of medicines. Another potential impact is for perforated or taped TE seals on cartons. While these are usually located such that no information required by the Order is damaged upon opening, the prescriptive format of the MIP means that for many cartons, the TE seal will on some occasions tear or damage part of the MIP. We feel that this requirement is too prescriptive and results in the following:

Well known, low risk products will be unable to comply;

For these products, S14 exemptions at present offer the only way of overcoming the issue

S14 do not provide business certainty and increase costs

There are significant costs to industry if this issue is not addressed – sponsors will be required to pack their products in different containers / packaging, increasing costs and requiring manufacturing site changes or significant capital expenditure to achieve this

There have been no safety issues posed by: roll wraps, cough drops, antacid chewable tablets or TE seals.

ASMI believes that significant change to this section is required. We do not believe that the TGA has justified these onerous requirements in relation to this group of low risk products.

73

Section 7

General

Requirements

456 Section 7(4) –

Compliance with

TGAC

ASMI does not object with the requirement for medicine labels to comply with advertising requirements. However, this draft TGO 79 has taken the approach (for other parts of the Order) of not cross-referencing to other legislative requirements. This was the reason provided for not stating the requirement to have the AUST R / L on the main label panel.

Section 8

Information to

be included on

the label

TBD TBD As stated above, ASMI queries why the requirement to include the AUST R or AUST L on the label is not included in the draft Order. This could foreseeably lead to errors in preparation of labels. The TGA has not been consistent in its stated approach throughout the draft Order, and refers periodically to the Therapeutic Goods Advertising Code in section 7(4), the requirement to include the AUST L number for the labelling of kits (S 8(12)(l)), the Poisons Standard, and the “Prescribing Medicines in Pregnancy” database.

TGA to consider including the requirement for

AUST R or AUST L, in 1mm letter height, as per

TGO 69.

74

Section 8

Information to

be included on

the label

472 Section 8(1)(a) –

Name of the

medicine

As mentioned above (in “Interpretation”, line 345), the change to the interpretation of “name of the medicine” will have an impact on sponsors’ ability to use generic foils on different dosage forms of the same brand name, active ingredient and strength. This would add to costs by requiring separate foil print runs and development of different foils for all of the different variants. In addition, the new interpretation will affect sponsors’ ability to display flavour variants on labels, due to the additional requirements on how the medicine name should be presented on the label, as per section 9(2)

TGA should clarify and amend wording to

enable:

Sponsors of non-prescription medicines to

use generic foils for medicines with the

same name but different dosage forms (e.g.

Nurofen ibuprofen 200mg tablets, capsules,

capsule shaped tablet, soft gel capsule

should be able to use a generic “Nurofen

ibuprofen 200 mg” foil.

Sponsors of non-prescription medicines to

have the flexibility to display flavours of a

product within a starburst or other graphic

feature, not necessarily as part of the name

in a continuous uninterrupted manner.

Section 8

Information to

be included on

the label

473 Section 8(1)(b) –

Active ingredients

As written, in 8(1)(b), i.e. “the name(s) of all active ingredients in the medicine” it implies that only the name of the therapeutically active component is needed (cross referencing to definition of active ingredient). If this part is written as “name(s) of all active ingredient(s), then this refers to the name as included in the AAN. We note that this wording is the same as that used in 9(1)(b); meaning that only the name of the therapeutically active component is needed. This is confusing and inconsistent with the guideline. The name in the AAN includes waters of hydration / solvates, and the guideline contains differently worded provisions for how the name should be written.

TGA should revise the guidelines for consistency

with the TGO.

TGA should make the guideline less confusing.

Further industry consultation is needed with

respect to the adoption of the IHIN

requirements.

ASMI prefers status quo for expression of active

ingredient name in order to minimise

inconsistency with active ingredient naming and

strength presentation among different

products.

75

Section 8

Information to

be included on

the label

480 Section 8(1)(i) –

name and contact

details of sponsor

This section sets requirements for amending the name and contact details of the sponsor following changes. ASMI is concerned that the TGA will regard this as a 12 month timeframe for changeover. We acknowledge that the TGA’s stated view is that the existing Order does not address this issue, however there are some factors that should be raised:

12 months is generally not a realistic timeframe for sponsors who have acquired a large number of products following a merger or acquisition; it is a large logistical exercise to update labels, complicated by issues such as changes to manufacturing sites and global re-positioning of products

12 months is unrealistic for slow moving or seasonal products, e.g. cough cold, allergy, sunscreens

The receiving sponsors will generally have arrangements in place to continue the contact numbers of the previous sponsor, usually for the duration of shelf life of products.

If a time period is to be introduced into the order, it should be understood that this represents a time within which sponsors may apply for a S14 exemption, rather than a firm cut-off date

The TGA should make it clear that these S14 applications will not be turned down on the basis of what is written in this Order

ASMI do not believe that the TGA have demonstrated that there have been problems in this area, or that inclusion of this section actually addresses any of these problems. Further consultation may be required. ASMI does not believe that there is a need to

include this requirement in the Order and that

there is no evidence that there have been

problems with the TGO 69 as currently written.

76

Section 8

Information to

be included on

the label

500 Section 8(1)(j)(iv)

– Schedule 1

ASMI notes that the Schedule 1 requirements are intended to be confined to non-prescription medicines by use of the wording “except where the medicine contains a substance included in Schedule 4 or Schedule 8 of the Poisons Standard…..” ASMI suggests that 8(1)(j)(iv), lines 500-502 should refer to “medicines in Schedule 4 or Schedule 8 or is a human blood product…..” as some OTC medicines contain active ingredient substances that also have entries in Schedule 4 of the Poisons Standard.

ASMI suggests that 8(1)(j)(iv), lines 500-502

should refer to “medicines in Schedule 4 or

Schedule 8 or is a human blood product…..” as

some OTC medicines contain active ingredient

substances that also have entries in Schedule 4

of the Poisons Standard.

Section 8

Information to

be included on

the label

507 Section 8((k)(i) –

medicines for

external use

The definition for “external use” excludes rectal and vaginal products, for which a “Caution: Not to be swallowed” warning statement might be useful.

Section 8

Information to

be included on

the label

512 Section 8(k)(ii)(B)

and

Section 8(k)(iii)(B)

Warning

statements

The proposed wording excludes medicines that contain substances that are in Schedule 4 or Schedule 8. ASMI notes that some OTC medicines, for example paracetamol, ibuprofen, chloramphenicol, PPIs, cetirizine, among others, are found in OTC medicines but are also substances included in Schedule 4 and Schedule 8. For clarity, ASMI suggests that the wording of 8(1)(k)(ii)B and 8(1)(k)(iii)(B) ought to refer to either “where the medicine is not included in Schedule 4 or Schedule 8” or “where the medicine is not scheduled, or in Schedules 2 or 3 of the Poisons Standard” in order to cover substances that are available as Schedule 4 but also as OTC medicines in smaller pack sizes or particular presentations.

Amended wording needed, for example:

“where the medicine is not included in Schedule

4 or Schedule 8” or

“where the medicine is not scheduled, or in

Schedules 2 or 3 of the Poisons Standard”

77

Section 8

Information to

be included on

the label

535 Section 8(1)(l)(i)

Directions for use

The wording, as currently written, excludes medicines that contain substances that are in Schedule 4 or Schedule 8. ASMI notes that some OTC medicines, for example paracetamol, ibuprofen, chloramphenicol, PPIs, cetirizine, among others, are found in OTC medicines but are also substances included in Schedule 4 and Schedule 8.

Amended wording needed, for example:

“where the medicine is not included in Schedule

4 or Schedule 8” or

“where the medicine is not scheduled, or in

Schedules 2 or 3 of the Poisons Standard”

Section 8

Information to

be included on

the label

541 Section 8(1)(l)(iii)

– Inclusion of

directions for use

on a leaflet

ASMI does not disagree with the inclusion of this requirement. It should be noted however that the directions for use are important for consumers and the aim should always be to include directions for use on the container or primary pack as applicable. Leaflets can be lost or discarded or separated from the product. ASMI believes that the label should carry all of the information needed for safe use. Therefore, placing directions for use only on the leaflet should be the options taken when all other options (such as flexibility with formatting the MIP or truncating the MIP) have been exhausted. As part of the discussion on the MIP, ASMI has made some suggestions regarding how this could be achieved.

ASMI does not require this section to be

amended, however other changes should be

made to the draft TGO 79 to allow directions for

use to be more easily accommodated on a

diverse range of packaging types and label sizes,

so that all information required by the

consumer for safe use is present on the label.

78

Section 8

Information to

be included on

the label

558 Section 8(1)(n)(i)

– Statement of

purpose

The proposed wording excludes medicines that contain substances that are in Schedule 4 or Schedule 8. ASMI notes that some OTC medicines, for example paracetamol, ibuprofen, chloramphenicol, PPIs, cetirizine, among others, are found in OTC medicines but are also substances included in Schedule 4 and Schedule 8. For clarity, ASMI suggests that the wording of 8(1)(n) ought to refer to either “where the medicine is not included in Schedule 4 or Schedule 8” or “where the medicine is not scheduled, or in Schedules 2 or 3 of the Poisons Standard” in order to cover substances that are available as Schedule 4 but also as OTC medicines in smaller pack sizes or particular presentations.

Amended wording needed, for example:

“where the medicine is not included in Schedule

4 or Schedule 8” or

“where the medicine is not scheduled, or in

Schedules 2 or 3 of the Poisons Standard”

Section 8

Information to

be included on

the label

578 Section 8(1)(p) –

Machine readable

code

8(1)(p) - A machine readable code if the medicine contains a substance in S4 or S8 – this wording should be amended (as above). Most if not all non-prescription medicines require a bar code on labelling. For many, it is a full sized barcode required by grocery retailers.

Amended wording needed, for example:

“where the medicine is not included in Schedule

4 or Schedule 8” or

“where the medicine is not scheduled, or in

Schedules 2 or 3 of the Poisons Standard”

79

Section 8

Information to

be included on

the label

582 Section 8(1)(q) –

Dispensing label

space

This requirement applies to medicines that contain a substance included in Schedule 4 or Schedule 8 of the Poisons Standard. Some OTC medicines, for example paracetamol, ibuprofen, PPIs, cetirizine, among others, are found in OTC medicines but are also substances included in Schedule 4 and Schedule 8. For clarity, ASMI suggests that the wording of 8(1)(n) ought to refer to either “where the medicine is not included in Schedule 4 or Schedule 8” or “where the medicine is not scheduled, or in Schedules 2 or 3 of the Poisons Standard” in order to cover substances that are available as Schedule 4 but also as OTC medicines in smaller pack sizes or particular presentations.

Amended wording needed, for example:

“where the medicine is not included in Schedule

4 or Schedule 8” or

“where the medicine is not scheduled, or in

Schedules 2 or 3 of the Poisons Standard”

Section 8

Information to

be included on

the label

589 Section 8(2) –

intermediate

packaging

This section clearly refers to opaque intermediate packaging. ASMI suggests that Section 7(1), which also refers to intermediate packaging, should also clearly refer to opaque intermediate packaging for consistency. There should be no requirement for intermediate packaging that is transparent or translucent to be labelled with the requirements listed in 7(1).

Amendment to Section 7(1) required for

consistency.

Section 9

Information to

be included on

the main label

TBC Requirement for AUST R / AUST L should be

included.

80

Section 9

Information to

be included on

the main label

606 Section 9(1)(a) –

Name of the

medicine

ASMI has raised previously (under Interpretations) some of the issues related to the definition for name of ingredient.

Consideration should be given to allowing

flavour variants to be displayed on the label as

per current arrangements. Flavour variants

should not be subjected to the requirements for

presentation of the name.

81

Section 9

Information to

be included on

the main label

607 Section 9(1)(b) –

Name of the

active ingredient

and

Section 9(1)(c) –

Quantity or

proportion of

active ingredient

The name of the active ingredient and the quantity or proportion of all active ingredients in the medicine are related issues. The name of the active ingredient is the name that is accepted for inclusion in the Australian Approved Names List (AAN). If the AAN names are harmonised to be consistent with the International Harmonised Ingredient Names (IHIN), some names will change and for some substances, the waters of hydration and solvates will be included as part of the name in addition to the salt. Guidance on how to express quantity or proportion are then provided in the Guideline document. The Guideline (Section 4.1) provides a complex set of instructions, stating that for salts, hydrates and solvates, the name of the salt, hydrate or solvate is included only once on the label, and not repeated or emphasised unless there is a good reason to do so. A series of recommendations then follow, on how this is to be achieved. The Guideline states that “Labels are to provide consistent strength information for all medicines containing the same active ingredient”. ASMI supports this principle, however there are practical difficulties with the requirements of the draft TGO 79 and interpretation of the guideline it may be difficult for this objective to be met.

ASMI contends that the TGA’s proposals in the

draft TGO 79 and related guideline can cause

consumer confusion when applied to OTC

medicines and in some cases will require

changes to how active ingredient names and

strengths are expressed on labelling.

ASMI believes that it should not be a

requirement for sponsors to change the way

that active ingredient quantity or proportion is

expressed on labelling compared to existing

arrangements. It can cause consumer confusion

as well as require updating to promotional

material and product lists.

This issue is discussed in more detail in the first

part of the submission.

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Section 9

Information to

be included on

the main label

619 Sections 9(2)

Name of the

medicine on the

main label must

be presented in a

continuous,

uninterrupted

manner and not

be broken up by

additional

information,

logos, background

text or graphics;

ASMI is concerned that these requirements will have an impact on branding and are inconsistent with the TGA’s stated position that it does not intend to adversely impact branding. There are concerns that some brands / logos / trademarks will be impacted. Example – the butterfly on Elevit; the “S” on the disk representing Strepsils; the use of, for example, a foot for a tinea product, a “flame” graphic for a heartburn product; a face / nose on a sinus product; a chest graphic for a chesty cough medicine. Some of these graphics are situated close to the medicine name on non-prescription medicines. The use of graphics is helpful to consumers and is often used as a way of differentiating products and assisting consumer self-selection. Although the TGA has stated that this requirement is taken directly from the UK PAGB requirements, it should be noted that the PAGB document is a guidance document and not legally binding. The context of this statement being part of a legislative instrument is very different. ASMI does not agree that this should be in a Labelling Order as it is too subjective, with a significant potential to impact branding and trademarks of non-prescription medicines. Also, non-prescription medicine names are not always presented in a “linear” fashion, and umbrella segments of a name can appear within coloured boxes or other graphic devices such as swirls, beacons, using different font styles and sizes or backgrounds. Flavours, which are sometimes part of the name, are often presented in a flash, a starburst or in other ways. ASMI believes that this section of the Order will have an impact on branding and design, and attempts to make rules for design.

ASMI believes that the TGA should not be ruling on design matters. This requirement is better suited to guidance rather than the Order, and ASMI recommends it be part of guidance as is the case in the UK. It is inconsistent with the TGA’s stated position that it does not intend to impact branding through the implementation of the TGO. The common name of active ingredients for herbal medicines and vitamin/mineral products should continue to be allowed on labels to assist consumers with purchase; this should not be regarded as “additional text” and should be allowed to be displayed together with the AAN name.

83

There is also significant concern regarding the ability to use the common name of herbs or vitamins. The common name (e.g. “Vitamin D”) is non-statutory information or additional text, which according to the Order should not be part of the medicine name and active ingredient information. Labels of non-prescription medicines should be allowed to refer to the common name of herbal / vitamin names together with the AAN information for active ingredients.

84

Section 9

Information to

be included on

the main label

622 Section 9(3)(a) &

9(3)(b)

Placement of

name of the

medicine

While ASMI generally supports placement of the active ingredients under the medicine name, we have concerns at the strict, prescriptive wording in relation to this requirement.

Some trademarks cannot be altered to suit this

requirement, e.g. the Panadol beacon, the Nurofen

target graphic device, and many others. These are

global trademarks. For products with global branding

and trademarks, it should be acceptable to show the

active ingredient below the branding, or to the side of

the branding provided its prominence is not affected

and provided it is not obstructed by additional text.

Further to this, some brands use silver “foiled” design

as part of their branding, for example the Nurofen

“beacon”. It is not possible to print over foiled designs,

therefore printed text must be placed under the

beacon in this instance.

The UK labelling examples seen by ASMI show

placement generally below the active ingredient

without intervening text or graphics, but more

flexibility is shown.

ASMI believes that active ingredients need not

be “a cohesive unit” with the name and this is

too prescriptive and will impact branding.

It should be sufficient to specify that the active

ingredients should appear under or near the

medicine name, uninterrupted by other text, as

per UK practice.

Branding and trademarks should not be

impacted by the Order, consistent with TGA

communication to members. The TGO should

reflect UK practice, which shows a greater

degree of flexibility.

ASMI agrees with Section 9(3)(b), which makes

allowance for kits and composite packs.

85

Section 9

Information to

be included on

the main label

630 Section 9(4)

All text required

by the Order

should be

oriented in the

same direction.

There are some well-known and clearly recognisable

brands in tall primary packs that have the medicine

name in a different orientation. This is part of their

long-standing brand design and makes the name of the

medicine prominent. This has not had any impact on

public health.

The TGA has not demonstrated that there is any safety

risk with this design on non-prescription medicine

labels that ought to be mitigated by this requirement.

Also, often AUST R / AUST L is printed in a different

orientation.

ASMI believes that this requirement poses an impact

on branding, and does not address any demonstrated

safety concerns.

The Order should not seek to mandate design

elements and for non-prescription medicines,

there is no safety impact due to the orientation

of the name.

This requirement should not be part of the

Order.

ASMI’s preference is for this requirement to be

included in the Guideline. It should not affect

currently marketed products or force sponsors

to re-design their brand.

The Order should also allow the AUST R/AUST L

to be printed in a different orientation to make

optimal use of space or to allow different

orientations on packaging lines if it is inkjet

printed onto the label.

Section 9

Information to

be included on

the main label

632 Section 9(5)

Active ingredients

should be

identifiable

through choice of

font, size, colour

etc.

ASMI believes that this requirement is better suited to a guideline as it is very interpretive and can potentially impact labelling designs. The question may also be asked – how will this requirement be assessed?

This requirement should not be part of the

Order.

ASMI’s preference is for this requirement to be

included in the Guideline.

86

Section 9

Information to

be included on

the main label

646 Section 9(7)(a)

Active ingredient

font size

This has been discussed extensively in the first part of the submission. The proposed font size is unachievable for non-prescription medicines. It is inconsistent with UK as practiced. When considering UK labelling, there is no prescribed font size, which allows sufficient flexibility for the font size to be proportional to the amount of label space. The UK also does not have signal headers and in many cases the salt and quantity or proportion of active ingredient is not needed, thus freeing up label space on the main label. An alternative approach is required, that is suitable for as many as possible medicine types and label sizes, in order to minimise the impact on branding, ensure that changes to container types, packaging types and label dimensions are not needed, and to reduce the likelihood that S14 exemptions will be required. ASMI has considered various options and thought through the implications for a variety of products and label types. We offer realistic suggestions of what should be achievable in practice that also delivers an increase in active ingredient prominence.

Please refer to the first part of the submission

for discussion on ASMI proposals for active

ingredient prominence and font size.

ASMI’s preferred approach is for registered

non-prescription medicines, both registered

complementary medicines as well as OTC, that

are not small or very small containers, and do

not contain more than four or more active

ingredients, to be displayed in a font size of not

less than the equivalent of 8 points Arial. This

would most likely be achievable on all but few

containers and labels, though testing may be

required.

An alternative, acceptable approach is to allow

the equivalent of 8 points Arial on

“intermediate non-prescription medicine

labels”, a definition that requires careful

consideration and recommended by ASMI to be

defined as less than or equal to 70 cm2.

As stated in the submission, a label this size

may not intuitively appear to have trouble

fitting the desired information in a larger font

size, however there are certain labels that have

long brand names, multiple ingredients, and

also require product uses on the label to assist

consumers, resulting in difficulty with a larger

font.

87

ASMI supports different font size for registered

non-prescription medicines, consistent with a

risk based approach.

The proposals described briefly above, and in

more detail in the first part of the submission,

still achieve a significant increase in

prominence.

Section 9

Information to

be included on

the main label

662 Section 9(8)(b)

Requirements for

registered

products with

four or more

active ingredients

ASMI supports the proposed requirement, allowing medicines for which 10(20) applies to not display the active ingredients on the main panel.

For clarity, either in the Order or the guidance,

sponsors would like confirmation that if the

active ingredients are shown on the main label,

then this information need not be duplicated on

the MIP, in the interests of maximising available

label space.

Section 10

Qualifications

& special

requirements

889 Section 10(12)

Medicine Kits

Sections 10(12)(f) & (g) state that a statement of purpose and directions for use are needed except where the kit contains a medicine with a substance in Schedule 4 or Schedule 8. As mentioned above in some previous sections, some OTC medicines have substance entries in Schedule 4 therefore this wording requires correction. Section 10(12)(l) states that the listing number of the kit is required consistent with the Regulations. It is confusing for sponsors when this requirement id mentioned in the Order in relation to medicine kits but not for other medicines.

The wording of Sections 10(12)(f) & (g) requires

correction so that the requirement applies to

medicines that are not in Schedule 4 or

Schedule 8 of the Poisons Standard.

88

Section 10

Qualifications

& special

requirements

917 Section 10(13)

Starter packs

The first paragraph of this section refers to medicines that contain a substance included in Schedule 4 or Schedule 8. As per some sections described above, some Schedule 2, 3 and unscheduled medicines also contain a substance listing in Schedule 4. All non-prescription medicines should be excluded from the starter pack requirements. This should also be clarified in the interpretation (section 6), as well as in sections 8 and 9. Some non-prescription medicines also have starter packs or sample packs, and these should not be included in the requirements of 10(13). There should not be any limitation on pack sizes doe non-prescription sample packs or starter packs.

Rewording is required so that this section does

not apply to non-prescription medicines.

Section 10

Qualifications

& special

requirements

929

And

968

Section 10(14)

Small containers

And

Section 10(15)

Very small

containers

ASMI agrees with the requirements for small containers, however we note that these concessions for labelling of small and very small containers only apply of these containers are enclosed in a primary pack, the label of which complies with the requirements of the Order. ASMI contends that the primary pack for these medicines is also small – i.e. the primary pack for a 10 mL bottle of eye drops or a 5 g tube of cream is also correspondingly small. Consideration should be given to allowing reduced font size for active ingredients on the primary pack as well. ASMI believes that a font size of nlt 8 points Arial on the primary pack should be considered as well. Other countries e.g. US, Canada, allow some flexibility with containers that are small.

The labelling of the primary pack that contains

the small or very small containers is also

correspondingly small. The smaller font size

should also be allowed on the primary pack.

ASMI has discussed active ingredient

prominence in more detail elsewhere in this

submission.

89

Section 10

Qualifications

& special

requirements

988 Section 10(16)

Individually

wrapped goods

The proposed requirements for individually wrapped goods are very unclear, impose a significant regulatory burden compered to TGO 69 and have the potential to adversely impact low risk non-prescription medicines such as lozenges and pastilles. Section 10(16)(a) applies to individual dosage units such as tablets, capsules, pills, pastilles, cachets, lozenges, pessaries, suppositories, single doses of a powder or liquid, or a transdermal patch – when each dosage unit is enclosed in an individual wrapper, sachet or blister, whether sealed or unsealed (our emphasis). Section 10(16)(b) – which allows for reduced labelling requirements of individual wrappers, applies only to pastilles or lozenges, when each dosage unit is individually wrapped in an unsealed protective cover. ASMI notes that there is no definition of protective cover in Section 6 – Interpretation, and requests further clarification of what constitutes an unsealed protective cover [10(16)(b)], and how this differs to an unsealed individual wrapper [10(16)(a)]. The reduced labelling requirements only apply to pastilles or lozenges. These should be extended to chewable tablets, to allow existing chewable antacid product wrappers to be labelled with only the name of the medicine. Significant costs and labelling / packaging problems will be incurred if these products need to be labelled as per section 10(16)(a)(v) to (x). The interpretation of name of the medicine also poses some specific concerns in relation to individually wrapped goods, particularly since the definition includes flavour.

Clarification and re-wording is required.

Chewable tablets should also be allowed the

reduced labelling requirements, in addition to

pastilles and lozenges.

The ability to use only the brand name on the

wrapper should be retained.

ASMI requests further clarification and consultation on the labelling of individually wrapped goods, particularly in relation to low risk OTC medicines such as throat lozenges, antacids, vitamins etc.

90

This may affect sponsors’ ability to use generic wrappers/protective covers that state the brand name but not the flavour variant (e.g. “Anticol” instead of Anticol Raspberry or Blackberry, “Soothers” instead of Soothers Lemon & Lime or Orange & Mango, “Berocca” instead of Berocca Orange or Orange & Mango or Tropical). Identifying the flavour variant on the wrapper itself is not a significant requirement related to safety for these types of low risk medicines. However, the definition of “name of the medicine” includes the wording - (see section 6 Interpretation: name of the medicine, (a)(vii) “flavour descriptors (except where this is integral to differentiate medicines from other medicines)”. ASMI believes that this terminology is confusing since each different flavour variant has a different AUST R or AUST L, and thus it could be said that flavour differentiates one AUST R or AUST L from another - implying that the flavour descriptor would be needed on each individual “protective cover”. If the intent of the definition is to exclude flavour variants, then this should be more clearly stated, i.e. “sponsors have the option to exclude flavour variants from the name of the medicine where appropriate” or similar. ASMI notes that TGO 69 differentiated between sealed individually wrapped goods and those in unsealed protective covers, whereas the draft TGO 79 confusingly refers to both wrappers and protective covers as being either sealed or unsealed. Adding to the confusion on this section is the fact that the Guidelines imply (section 9.8, page 32) that

91

lozenges and pastilles are not captured in 10(16)(a), and that these are referred to only in the context of 10(16)(b).

Section 10

Qualifications

& special

requirements

1023 Section 10(16)(d)

Transdermal

patches

Some OTC nicotine transdermal patches are labelled with the brand name alone (e.g. Nicorette), and different strengths of the patches are identifiable by their different size or dimensions in cm2. ASMI believes that since these patches are labelled with the brand name of the medicine, easily identifying the patch as being for nicotine replacement therapy, the fact that the patches have differing dimensions for the different strengths should be sufficient for compliance with 10(16)(d). Nicotine patches are not manufactured specifically for the Australian market, and Australia sources these from overseas. Imposing unique Australian requirements would result in higher cost of goods since Australia would be required to accept a unique small volume batch run for these goods.

For nicotine transdermal patches, some are

differentiated according to size.

If the patch is named with the brand name,

then size of the patch should also be regarded

as sufficiently differentiating between

strengths.

92

Section 10

Qualifications

& special

requirements

1064 Section 10(16)(c)

Strip, blister &

dial dispenser

packs

ASMI interprets section 10(17)(c) to mean that composite packs with two formulations in the one blister will not require the name and strength of all active ingredients on the blister. ASMI supports this approach as there is insufficient space to list all of this information on blister strips for composite packs. ASMI also interprets from this section that “scatter printing” of details on blister packs will be allowed provided that there are sufficient repetitions of information. If our interpretation is correct, we support this.

93

Section 10

Qualifications

& special

requirements

1108 Section 10(20)

Medicine

Information Panel

ASMI supports the principle of some standardisation of back of pack information required by consumers, to assist in:

selecting the appropriate medicine

using the medicine safely ASMI’s view is that section 10(20) should set some minimum requirements as a benchmark, but should not be overly prescriptive. Label testing has revealed that the MIP as proposed will not fit on many labels due mainly to duplication of information and inflexibility. Sponsors are also having difficulty interpreting the grouping of information as proposed by the TGA, particularly for additional warning statements used by sponsors that are not part of RASML, as well as warning statements that are present in RASML, but which the TGA has not grouped under “Warnings” in the example shown as part of Schedule 2 of the draft Order. ASMI has discussed the MIP in more detail in the preceding part of the submission, and there are some important changes that ought to be considered:

Abridgement by removal of duplicated information if label space does not permit

Allowing warning statements that are not part of RASML to be included in “Warnings”

Further clarity regarding some non-specific warning statements included in RASML that are not precautions or contraindications. An example is “Do not exceed the recommended dose” which TGA has included in “Directions for use” in its example.

Consider not requiring the MIP for some very low risk medicines such as hand sanitisers, toothpastes, roll wrap antacids, otherwise a realistic approach

94

should be adopted due to space problems for some of these medicines.

The TGA should allow sponsors who undertake label improvements for new formats or layouts of labelling to submit these for approval. The MIP should propose the minimum requirements but should not attempt to prevent ongoing development and consumer testing of new label formats and designs.

In summary, the Order should apply a minimum standard, and the guidelines should provide optional “best practice” information that can be followed if space permits. ASMI also supports alignment with the Canadian and US approach for requiring the MIP only on the primary pack, not on the containers within the primary pack.

Section 11

How

information is

to be

expressed

1207 Section 11(2)

Expression of

quantity or

proportion of

active ingredients

The proposals in section 11(2)(ii) may cause confusion. It should be clear that for some medicines, where there is a range of suitable doses, e.g. for different ages of children, or a dosage range for adults, it should be allowable to express the dose in mg / mL, including when the medicine is one of a series of strengths containing the same medicine. In the case of non-prescription medicines, where there are varying strengths of (for example) phenylephrine or guaiphenesin or pholcodine, it is also preferable to express as mg / mL to allow comparison.

Expression of active ingredient in the stated

volume should be allowable, even where there

are different strengths.

This should also be allowed where there is

dosage variation, e.g. in children’s products.

This assists in comparing the strength of

medicines.

95

Section 11

How

information is

to be

expressed

1306 Section 11(2)(j)

Expression for

medicines

containing herbal

preparations

The TGO 69 refers to herbal substances being expressed as the equivalent dry or fresh weight. The draft TGO 79 section 11(2)(j)(iii)(B) refers to “derived from”. The Guidance document refers to “equivalent” and “derived from” interchangeably on page 29 of the document. This change could be interpreted as a requirement to change the expression on the label. TGO 79 should be changed to incorporate “equivalent dry or fresh herbal material” so as to avoid confusion.

Sections 11(2)(j)(iii)(B), (C), (D) should amend

“derived from” to “equivalent to”, consistent

with current terminology in TGO 69.

The Guideline should also be amended to show

consistent terminology.

The use of “equivalent to” is terminology that

consumers are accustomed to reading on

herbal preparation labels and a change to

“derived from” creates potential for confusion.

96

PART 3 – ASMI RESPONSE TO REGULATION IMPACT STATEMENT

97

REGULATION IMPACT STATEMENT

GENERAL REQUIREMENTS FOR LABELS FOR MEDICINES – ASMI

COMMENT

Overview of Concerns ASMI were somewhat disappointed that the Regulation impact statement - General requirements for

labels for medicines (the RIS document) did not propose an option which also provided education to

accompany the label changes. This would be the ultimate option which would ensure the impact of

label changes would be maximised, by explaining to consumers and health practitioners what the

changes are and how to now find the necessary information on the medicine.

ASMI appreciates the TGA’s initiatives to establish an economic model to determine the financial

impact of regulation and to assist in sensitivity analysis of the transition timeframe scenarios to

modulate the impact on industry. However ASMI are concerned that the impact of this significant

change on industry has been severely discounted in this document.

Some significant outcomes of TGA Medicine Labelling and Packaging Review Consultation May 2012, were that

TGA has no intention of implementing reforms that result in increases in the physical dimensions of packs/cartons

TGA understands the importance of branding for non-prescription medicines and the reforms are not intended to impact on branding

The RIS document is therefore written with the fundamental assumption that this Regulation is

intended as a change to labelling only, that is, it will not:

impact branding

require changes to current packaging specifications (dimensions or types)

require investment in packaging equipment or tooling.

However, the TGO 79 (as proposed) will have significant impact on industry, particularly on sponsors

of registered non-prescription medicines. If implemented without amendment TGO 79 would require

changes to packaging specifications and branding across the majority of these products.

Therefore the RIS document does not reflect the impact implementation of TGO 79 would have on

the OTC medicines sector. ASMI have already flagged our concerns to TGA with respect to the

implications of the TGO 79 and hope our response will provide constructive ideas for bringing the new

regulation back within the scope of the intent and the RIS.

Industry have acknowledged the benefits to the Australian community of greater active ingredient

prominence on the main label and consistent positioning of key pieces of information. However, it is

important that the true cost to industry of such an enormous undertaking is also acknowledged and

an appropriate transition period is therefore allowed. ASMI are concerned that the assumptions used

to underpin the economic model underestimate and unreasonably discount the costs to the industry

98

and to the registered non-prescription medicine sector in particular. This in effect trivialises the scale

of the investment the industry will make to further fortify the safety of medicines in the Australian

regulatory environment.

The reform costs as calculated and reported by the RIS document for the whole industry are very

minor for Option 3(c.) 4 year transition period - Total costs per year over 10 years for this option are

$0.7 million per annum. This compares starkly with the costs individual businesses are calculating to

make budgetary provision. One of ASMI’s members, a multinational, estimates these changes will

cost their business alone in excess of $6 million for just their non-prescription medicines over the

granted transition period. ASMI’s response explores the assumptions which underpin the RIS and why

such a differential in costings would occur (see Review and Appraisal of the RIS Assumptions) and

provides proposals to the assumptions to more accurately reflect the cost of the Regulation (see

Summary of Proposed Changes to RIS Assumptions to Reflect Cost of Regulation).

The extent of this regulatory change should not be underestimated relative to the previous updates

to the Labelling Order. ASMI would describe the update to TGO 79 as a stepwise change compared

with previous updates which were incremental in nature. A summary of the changes between TGO

48 and TGO 691 provides an indication of the comparatively minor extent of that update to the

Labelling Order. The scope of change of the TGO 79 has (or according to the RIS Document already

has had in the case of some generic prescription medicines) implications for every medicine label

where the scope of the change of TGO 69 was to only some medicines labels. For the update to TGO

69 a transition period of 30 months was allowed.

The RIS also provides a Regulation Benefit or net saving of the regulation. This is estimated based on

the “2.5 per cent of the total costs [$1.2billion annually] from incorrect medicine use or $30 million

per annum, of hospital admission attributed to medication errors.” We express concern should there

be any expectation the $30 million of Regulation Benefit will be delivered year on year in Government

Budgets, or be used as a post regulation assessment measurement. We understand the difficulty in

determining an appropriate measure of benefit. However we’d value some transparency of the

thinking behind this measure at this time the thinking is being applied. After the significant investment

being made by industry in good faith, it would be unfair to later hold the industry to account based

on an arbitrary measure.

ASMI believe the cost to the registered non-prescription medicines sector is disproportionate to the

risk arising from that sector, particularly when considered relative to the likely benefit arising from

this medicine sector. By contrast the extent of change to prescription medicines and listed medicines

while also impacting every product is likely to be more straight-forward to achieve and the cost of

compliance more moderate.

ASMI have worked hard within the overly complex constraints of TGO 79, to provide solutions to

minimise its impact to the intended scope i.e. amendment to labelling only.

Before the RIS is used to support this regulatory initiative, ASMI request amendments to the RIS

assumptions, and therefore the costs to industry represented in this document, so that it properly

1 Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69) – Summary of new or Amended Provisions (Page 111)

99

reflects the cost to industry of these significant medicine labelling changes. Further ASMI believe the

necessary changes to both TGO 79 and the RIS document are sufficiently significant that the industry

need to be given a further opportunity to confirm the final proposal and its impact.

The true cost of label change within a set transition period has long been a subject of debate between

industry and the regulator. ASMI suggest that this implementation represents an opportunity for the

Industry to invite staff of the TGA into their businesses to observe what is involved and to understand

the necessary processes. ASMI members would be happy to extend this offer.

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Review and Appraisal of the RIS Assumptions of Option 3

1. Size of the Change ASMI question if the size of the change has been adequately represented. We particularly note

the following two sets of assumptions on page 22 of the RIS Document:

“there are a total of 15,800 medicines that would require label changes. Of the 32,500

medicines included in the ARTG, 14,080 have a zero dollar turnover, indicating that they are

not currently being sold in Australia. A further 2,660 medicines are for export only and would

not be subject to compulsory label changes.”

“there are 8690 products that are either a single product or the first product in a range of

products with the same brand and active ingredient but differing in strength and 7110

products that are second and subsequent strengths.”

The equations here to identify the size of the change are:

Number of ARTG entries which will be required to change labelling as a result of the Order

Total no. medicines included on ARTG

(32,500)

–

no. not being sold

(14,080)

–

no. export only

(2,660)

=

total no. medicines requiring label change

(15,760) or 15,800

These numbers are consistent with the numbers provided in the LVT Scheme consultation.

Total no. medicines included on ARTG (30,460)

-

no. LVT exemptions (14,078)

=

total no. medicines included on ARTG (15,968)

Second and subsequent strengths of ARTG entries

Of the Total no. medicine entries requiring label changes

(15,800)

–

no. either single or first

product under a brand

with same active but

different strength.

(8,690)

=

second & subsequent

strength

(i.e separate and distinct

entry on ARTG)

(7,110)

This second and subsequent strength describes products that are a separate and distinct entry on

the ARTG. A non-prescription medicine example might be a Children’s single analgesic liquid

product in two concentrations, under the same brand. The single strength product labelled

suitable for dosing younger children, the double strength product labelled suitable to reduce the

volume for dosing older children. However unlike a prescription medicine, for example an

injection with a range of different strengths, where the only difference on the label will be the

strength and colour differentiation, the non-prescription medicine labelling across the two

strengths will differ markedly to ensure consumers can differentiate between the products. The

product name, along with clear indication of concentrated formula, graphics, dosing device,

dosing instructions. The assumption that second and subsequent products with the same brand

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and active but differing in strength can be handled as lesser changes therefore does not hold true

for non-prescription medicines

These assumptions also do not adequately represent the complexity of the number of labels that

need to change to comply with the TGO 79.

The majority of registered non-prescription ARTG entries (and to a lesser extent listed entries) will

have more than one stock keeping unit (sku) or pack size (e.g. 1 ARTG entry for Panadol Tablets

10s, 20s & 40s packs, or 1 ARTG entry for Duro-Tuss liquid 30mL, 100mL and 200mL packs). And

while this scenario might sound like the prescription medicine style ‘second and subsequent

strength’, where it is only the number of the size of the pack that will differ on the label, this is

regularly not the case.

E.g.1. Nurofen Tablets 12’s, 24’s and 48’s - While the 12’s and 24’s will differ for just the number

of tablets, the carton artwork for the 48’s pack differs not just in number of tablets but also the

inclusion of a signal heading on the main panel and the requirement for a different knife line for

the increased depth of carton to accommodate 4 blister platforms. In total for the one ARTG entry

3 carton artworks and one common foil artwork.

E.g. 2. Dimetapp Chesty Cough Elixir 25mL, 45mL, 100mL and 200mL – The 25mL and 45mL

products have the bottle label artwork only, where the 100mL and 200mL have a carton artwork

and bottle label artwork. While the designs are similar across the range, the label artwork layouts

for each sku will differ due to dimensional restrictions as will the carton artworks.

As indicated in these examples, not only will each ARTG entry have more than one pack size, but

many of those pack sizes will have more than one artwork which will require change e.g. for:

solid dose products one foil (for all pack sizes) and a carton (for each pack size),

liquid/cream products a bottle label (or printed or labelled tube) and carton each.

We would therefore expect a multiplier effect to the costs identified in the RIS for each ARTG

entry to reflect these additional complexities for non-prescription medicines.

The LVT Scheme Consultation identified a breakdown of number of ARTG entries across the

medicine sectors as follows:

Annual Charges LVT Exemptions Net Annual Charges

Type of Therapeutic Good Number of Units

Prescription Medicine – Biologics 1,011 555 456

Prescription Medicine – Non-Biologics 12,413 7,713 4,700

Non Prescription (OTC) Medicines 3,506 1,269 2,237

Listed (Complementary) Medicines 13,116 4,541 8,575

ASMI have requested data from members to identify the number of current Australian marketed

ARTG entries for both Registered and listed products (that would be subject to change) and then

the total number of registered product printed packaging and the total number of listed product

printed packaging.

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Non-Rx medicines Registered Sponsor

1 Sponsor

2 Sponsor

3 Sponsor

4 Sponsor

5 Sponsor

6 TOTAL

Qty of ARTG entries AUST R 125 42 63 31 56 89 406

Total No. pieces Labelling AUST R 380 211 150 135 212 242 1330

Multiplier 3.0 5.0 2.4 4.4 3.8 2.7 3.3

Non-Rx medicines Listed

Qty of ARTG entries AUST L 10 21 6 21 52 110

Total No. pieces Labelling AUST L 20 42 12 48 130 252

Multiplier 2.0 2.0 2.0 2.3 2.5 2.3

From this feedback we have been able to calculate an average multiplier per ARTG entry for:

Registered non-prescription (OTC) medicines of x3.3.

Listed complementary medicines of x2.3.

Annual Charges

LVT Exemptions

ARTG Entries

Label Changes

Type of Therapeutic Good Number of Units With

multiplier

Prescription Medicine – Biologics 1,011 555 456 456

Prescription Medicine – Non-Biologics 12,413 7,713 4,700 4,700

Non Prescription (OTC) Medicines 3,506 1,269 2,237 7,382

Listed (Complementary) Medicines 13,116 4,541 8,575 19,723

Total 15,968 32,261

Our members are very concerned that this complexity is not currently represented in the RIS

document but with these multipliers we start to understand the true size of the regulation

change. Rather than an assumption that discounts the significance of the label changes of 45% of

the ARTG entries as second and subsequent products under “a range of products with the same

brand and active ingredient but differing in strength,” ASMI instead advise that a multiplier is

required for non-prescription medicines, to account for multiple pack sizes per ARTG entry and

the multiple levels of labelling for each pack size.

2. Magnitude of the Change The RIS delineates all the changes necessary for Option 3 as ‘medium’ or ‘minor’ label changes.

We note that for Option 1. – ‘no change’ or just the changes necessary for business as usual (BAU),

those changes too are costed as ‘medium’ for first of a product range and ‘minor’ for a second and

subsequent product in a range. However for option 1 it needs to be clear that these label changes

are interpreted from the existing TGO 69 onto a label already compliant with TGO 69 and the

change is to one product or range of products and will typically have no mandated timeframe for

implementation.

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Under Option 3 the sponsor will be interpreting a completely rewritten Labelling Order, with new

definition of terminology and new clauses of requirement. For registered non-prescription

medicines the requirements are significantly different. The new prominence of active ingredient

will need to be achieved within the brand and product name design elements. This will require

reconsideration of the front of pack layout. For products with a range this will need to be

considered and managed to maintain the label differentiation across the brand range. The

Medicines Information Panel will also require a completely new text layout on the back of pack.

ASMI believe this scale of labelling change is major i.e., completely new layout of all information

in different format, and resizing/repositioning of logos/TMs on all packaging components. This will

require several rounds of briefing the graphic artist to achieve compliance and optimise the

product appearance within the company’s internal artwork approval processes. Further changes

may be required during the evaluation of the variation to the ARTG entry as the sponsor

understands how the evaluators interpret the new Order.

We understand that sponsors who assisted by providing survey data to enter into the model

provided costs for label change and production costs which have been averaged as follows:

‘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

While medium and minor label changes and production costs are appropriate for prescription and

listed medicines (on page 17), we advise that major label changes and production costs for first

products in a range and medium for second and subsequent changes should have been costed for

Options 3 a. b. and c. for all registered non-prescription medicines label changes (rather than ARTG

entries) (page 22). We understand that costing data for major label changes were also provided

as part of the survey data.

3. The Costs to Manage Achieving Compliance within the Transition Time Option 3 assumes no additional company resource time/cost for:

Managing this change of all product labels to be compliant for supply ex-warehouse within

the transition time and to minimise write-off of product and existing printed packaging.

Incremental increase to briefing and review of label artwork potentially requiring several

amendments to achieve all requirements satisfactorily.

The assumption (on page 22) that “it is estimated that more than half of medicine labels for

products marketed in Australia are changed every three years.” It then proceeds to assume that

no additional company resource will be required to update all medicine labels over a 2, 3 or 4 year

period, beyond the assumption (on page 23) that “it takes 20 hours to prepare an application for

variation for the first product strength on the ARTG. This time would include updating procedures,

policies and the time taken to assemble the necessary information and fill in the form to apply to

vary the application. Wage rates for the preparation of the application are $42 per hour.”

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However:

the new regulation represents a ‘hard’ change where all stock must change and be

compliant for supply by the set transition date, not, as is the case for BAU changes, a ‘soft’

change for a couple of skus at a time, where old stock can be exhausted before the new

stock commences supply. It therefore requires careful project management with the

involvement of a cross-functional team to achieve compliance and minimise stock write-

off.

the time differential to brief and review a minor wording change to that required for a

complete interpretation of new requirements in layout is significant. The likelihood of

achieving a satisfactorily outcome in the first brief is also less certain for the latter.

We also note and question why the model does not include assumptions for Option 3 to account

for:

a. Write-off costs, both of printed packaging materials and current product still on hand

at the end of the transition period? Even with careful project planning every sponsor

will have some write-off.

b. Write-off of current promotional materials with pack-shots and preparation and

provision of new materials, a necessary regulatory compliance task.

For every ARTG entry a Change Control will need to be raised identifying the necessary changes

within the quality management system which flow from the changed requirement. These will

include the need for:

Issue of new product identification codes, new printed material item codes, development

and authorisation of new printed packaging material specifications, new Packaging Bill of

Materials, new Master Packing Instructions.

New artwork development brief with the review and approval of at least Marketing,

Quality, Manufacturing (and or Packaging) and Regulatory authorising signatories on each

affected label.

Regulatory application for approval to vary the product registration in all marketed

territories.

The project team will require involvement of Supply, Manufacturing, Quality, Marketing and

Regulatory to implement the change.

The Supply procurement planning need to identify how to best minimise waste and to identify the

order of priority of the label changes across the product portfolio and the dates by which all new

labels will need to be in production to meet transition timeframes. High volume products provide

a greatest opportunity to minimise write-off impact, with a high frequency of manufacture. Low

volume products may be made as infrequently as one batch per year. Small volume products are

likely to have a high level of existing printed packaging materials on hand, with minimum order

quantities likely to be larger than the size of a single production, and will have fewer opportunities

to reduce the level of write-off.

One ASMI member was able to give an example of packaging write-off alone arising from change

of sponsor contact details across 89 ARTG entries of registered non-prescription medicine due to

a recent company merger. This change did not have a regulatory set date by which stock must be

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compliant in market it was bounded by the terms of the merger. Even with careful management

to run out existing packaging there are always quantities insufficient to pack off a whole batch left

over. In this instance the total write-off cost across all 89 ARTG entries was $173K.

With set transition dates by which stock must be compliant for supply, there is always the fine line

of maintaining stock coverage. An unexpected spike in sales can plunge a sponsor out of stock,

while a dip in sales can leave the sponsor with surplus stock beyond the transition time. Stock

surplus will require write-off and further investment to either rework or appropriately dispose of

it, typically by high temperature incineration.

A further complexity for managing the project for registered non-prescription medicines will occur

where the product is part of a range under an umbrella brand. There is a likelihood that during

the evaluation of the change labels for one product in the range, is that “Labels for other medicines

in the umbrella range may be requested in order to demonstrate that differentiation is adequate.”

Therefore label updates will not be able to be prioritised based on procurement priorities alone.

The majority of our members market a high proportion of their products in both Australia and

New Zealand and attempt to maintain consistent labelling in both markets for product viability.

Another cost and timeframe implication to the industry from a regulatory perspective is the

requirement to also submit a change medicine notification (CMN) to Medsafe to maintain the

common label. Industry cannot be certain that Medsafe will be in favour of the changes,

particularly with respect to the Medicine Information Panel and the presentation of the active on

the main panel of the label. Medsafe signalled their concerns with the Medicine Information

Panel in their response to the TGA’s Labelling and Packaging Review May 2012, written from the

perspective of progressing toward the establishment of a Joint Trans-Tasman Agency, as follows:

“We support the overall intent of the proposals relating to the Medicine Information Box. However, we have the following concerns about specific elements of the proposals:

(i) Until recently, New Zealand required the label on an over-the counter medicine to have certain information grouped together in a 'Consumer Information Panel. This requirement was removed because it was not consistent with requirements in other major markets. (ii) Such a requirement could create a situation where it is necessary to grant exemptions from the 'Medicine Information Box' requirement in order to ensure consumers have access to the full range of medicines available in other countries. Such an exemption mechanism is administratively cumbersome.”

There is therefore potential that sponsors could need to make a further variation to a label already approved by TGA to achieve a common label acceptable to both agencies TGA and Medsafe. For some ASMI members, common labelled packs are broader than just Australian and New Zealand and extend to some Asian countries.

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4. Discounting the costs of Regulatory Change based on inclusion of Business change ASMI note and question the appropriateness of the assumptions for Category 2, 3, & 4 changes

on page 23 where - “it is assumed planned changes for business reasons are brought forward to

avoid having to pay twice for label changes (once for the regulatory changes, once for the business

need).” And the follow-on assumption in Option 3a that only 50% of the costs are attributable to

business needs and 50% to the required regulatory changes for category 2, 3 & 4 labels (page 23)

and similar cost discounting assumptions of 3b and 3c.

Typical reasons for changing labels are;

a) a company merger/acquisition – change of sponsor and contact details,

b) a brand redesign,

c) a change of sponsor address and contact details,

d) a change of country of origin,

e) after successful switch of a substance,

f) in response and compliance to a substance switch, (e.g. the recent paracetamol Schedule

2 entry change to pack size for exemption from the schedule.)

g) in response to a product review (the Cough and Cold Review, the NSAID Review)

h) company response to a safety signal,

i) compliance with a RASML (MASS) update.

Not all these reasons are ‘business needs’ (f), (g) and (i) are driven by other regulatory change

compliance.

However some of these cannot be foreseen at the commencement of planning such a big change.

Others cannot be ‘brought forward’ or ‘put back’ to coincide with the new Labelling Order in

Australia. Therefore while there will be some serendipitous timings for some brands/companies,

the reality is that many labels will need to change twice or more during the transition period.

E.g. 1. Members are currently implementing changes to ensure compliance with the Medicines

Advisory Statement Specification 2014. They cannot afford to await publication of the new

Labelling Order to combine the necessary changes and risk not achieving MASS 2014 compliance

within the 18 month transition period.

E.g. 2 Company mergers are in progress within our membership, however it will be the terms of

the contractual arrangements that will dictate the timing of the change to sponsor details on the

labels. The ability to ‘put back’ the timing to coincide with the TGO 79 transition period would be

dependent on achieving an agreement to vary the terms of the contract.

The assumption that other than TGO 79 regulatory change all other determinants for varying a

label are due to ‘business needs’ is also questioned. Many of those reasons are due to other

regulatory changes. The notion of discounting the costs of the TGO 79 regulation 50% with

business when the second determinant of change is another TGA regulatory change can only be

described as inappropriately off-setting these costs as business related.

Additionally the high frequency with which business makes changes to labels appears based on

the assumption identified as a baseline under Option 1, i.e. 30% of all applications to vary an ARTG

entry are variations to labelling and the survey information presented under option 3, that more

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than half of all products change their labels every three years. The survey did not appear to drill

to determine the reason for the change.

Comparison of the numbers of ‘label’ applications for each type of medicine when consider as a

proportion of the number of ARTG entry numbers for each type of medicine leads us to question

the frequency of application to change labels presented in Option 1.

ARTG Entries Total

ARTG Entries Active

Labelling Variations Average p.a. (page 17)

Proportion Variations to ARTG Entries

Proportion Variations to Active ARTG Entries

Type of Therapeutic

Good

Number of Units % %

Prescription Medicine – Biologics

1,011 456 14205

106%

276%

Prescription Medicine – Non-Biologics

12,413 4,700

Non Prescription (OTC) Medicines

3,506 2,237 354 10% 16%

Registered Complementary Medicines

292 17 59% -

Listed (Complementary) Medicines

13,116 8,575 406 3% 5%

Total 15,968 14982

When the number of variations presented are considered relative to the medicine classification

and proportional to the number of ARTG entries for that type it becomes clear that:

(a) The vast majority of labelling variations relate to prescription medicines, which would

be an unexpected outcome. While attributed to labelling they are instead likely to be

variations to Product Information, which is outside the scope of TGO 79. This is

significantly distorting the total picture of the frequency with which variations are made

to labels across all medicine types.

(b) The number of variations to registered non-prescription medicine labels is low.

(c) The number of labelling variations made to listed medicine labels is very low.

ASMI suggest the level of discounting of the cost of the reform is unduly elevated and needs to

be more fairly addressed if not removed altogether.

5. Opportunity Costs We understand that a standard opportunity cost factor is determined by the Office of Best Practice

Regulation and at the time of preparing this RIS document that standard factor was 6%.

As stated above (see The Cost to Manage Achieving Compliance within the Transition Time) this is

a significant project to manage amendments to every label of every pack size of every marketed

2 http://www.tga.gov.au/list-evaluated-registered-complementary-medicines

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medicine ARTG entry, to submit the variations and manage the introduction of the new approved

labels into the supply chain for supply into the Australian market prior to the completion of the

transition, whilst minimising the write-off exposures to the company.

The size of this project will be resource intensive particularly to the Regulatory Affairs, and

Supply/procurement functions within a business and have significant opportunity cost

implications. To meet business growth objectives and achieve labelling compliance, many

companies will need to employ supply and/or regulatory contractors to manage the labelling

reform. There is no reference for such costs other than the standard OBPR allowance and the

following assumption:

“it takes 20 hours to prepare an application for variation for the first product strength on the ARTG.

This time would include updating procedures, policies and the time taken to assemble the

necessary information and fill in the form to apply to vary the application. Wage rates for the

preparation of the application are $42 per hour.”

6. Attribution of Costs over 10 years (page 23) Although not stated, the RIS document is written with the assumption that the introduction of

TGO 79 represents an amendment to labelling only. That is, this regulatory change will not require

change to packaging sizes and types and will therefore have no requirement for investment in

packaging equipment or tooling. All of the costs to achieve compliance will therefore be incurred

by industry over the transition period. After the transition is completed the TGO 79 will be the

Standard for Labelling and it will be part of business as usual.

ASMI therefore questions why the cost of the Regulation is attributed over a ten year period. The

rationale for the ten year period was unclear, we surmised net present value, amortising the value

of capital expenditure to the cost of the product over the life of the tooling/equipment. We

enquired and have been advised the ten year period relates to the average life expectancy of the

Regulation.

In practice all the costs burden is incurred during each scenario’s transition period and then the

Regulation becomes the standard cost of doing business. Conducting the sensitivity analysis for

each scenario over the transition period is more appropriate and would more accurately reflect

the stresses to industry. That is the impact of those costs over three different transition periods.

7. Transparency of the Regulatory Burden Cost Offset of $3 Million (page 25) ASMI notes the introduction of a cost offset of $3 Million attributed to Electronic Submission of

Data Dossiers OBPR ref: 14783. It is unclear what this offset is as there is no discussion of this cost

offset within the RIS document, and a Google search of this OBPR ref number provided no results.

It can only be assumed that this offset provides the industry with $3 million dollars benefit per

annum over ten years across all medicine types. ASMI request transparency of this item.

ASMI assume this relates to the TGA’s investment to facilitate eSubmission in both NeeS and eCTD

format. Without having any detail it is difficult to comment other than to advise that if our

assumption is correct this off-set will not apply to Listed Medicines.

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Summary of Proposed Changes to RIS Assumptions to Reflect Cost of Regulation

Firstly the sensitivity analysis should be conducted separately for each medicine type,

prescription, registered non-prescription and listed medicines to appropriately address

the complexities for each.

In recognition that ARTG entries for non-prescription medicines often have more than one

pack size and more than one piece of label artwork for each pack size, the costing model

needs to apply a multiplier to each ARTG entry. ASMI have surveyed our members to

understand the number of ARTG entries and the number of pieces of label artwork which

need to change. From averaging the data provided we recommend a registered non-

prescription medicine multiplier of x3.3 and for listed medicines x2.3.

For registered non-prescription medicines, ASMI believe the scale of labelling change,

even when contained within the intended scope of this RIS document, is major. The

second or subsequent product in a product range are at best medium. The artwork

redesign and production costs for the label should reflect this.

The level of resources necessary to necessary to implement this change have been

significantly underestimated. Resource allocation is limited to Regulatory. This is a project

with a hard milestone delivery date. It will demand significant resource from a cross

functional team.

The extent of impact on resource particularly in Regulatory and Supply/procurement

functions represents a significant opportunity cost to business. Provision should be made.

The resources also need to assume concurrent with applications to vary the product

licenses with TGA, application will also be necessary to Medsafe for a large proportion of

products of the order of 50%.

Provision needs to be made for write-off costs, both of printed packaging materials and

current product still on hand at the end of the transition period.

Provision needs to be made for the write-off of current promotional materials with pack-

shots and preparation and provision of new materials, a necessary regulatory compliance

task.

The level of discounting of the cost of the Regulation for options 3 (a), 3(b) and 3 (c) is

unduly elevated and needs to be more fairly addressed if not removed altogether.

The annual cost should be attributed over that transition period of the scenario rather

than over a 10 year period.

The detail of the Regulatory Burden Cost Off-set of $3 million per annum over 10 years

should be transparent. It’s applicability across all medicines should be carefully

considered.

Some transparency of the thinking behind the rationale of the calculation of the

Regulation Benefit at this time the thinking is being applied.

An Acceptable Transition Period ASMI do not believe the cost burden has been accurately described in the RIS Document, due to the

assumptions which have underpinned the development of the model.

ASMI believe that the cost burden of the Regulation to registered non-prescription medicines, even

when contained to the agreed intent, is significantly higher than that to Listed or Prescription

Medicines.

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It is important that industry have the opportunity to consider the final changes to TGO 79 before it is

made a legislative instrument and introduced as the new labelling order. Only at this time can we

understand the cost burden of what will be introduced.

At this time and on a ‘gut feel’ only, we would estimate a transition period of four years for listed

medicines would be acceptable and a transition period of five years for registered non-prescription

medicines would be necessary to acceptably address the complexities described in this response

which will impact cost and timeframe for implementation.

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Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69)

SUMMARY OF NEW OR AMENDED PROVISIONS

The following table summarises those provisions of TGO 69 which differ from those currently in force through Therapeutic Goods Order No. 48 ‘General requirements for labels for drug products’ (TGO 48)

CLAUSE PROVISION Details of change from TGO 48

Title Change of terminology from ‘drug products’ to ‘medicines’, reflecting a change already made to the Therapeutic Goods Act 1989

(the Act).

1(1)(h) Applications and exemptions – relating to goods solely for export

This subclause clarifies that the Order does not apply to the labelling of goods that are solely for export and reflects an existing provision of the Act.

1(1)(k) Applications and exemptions – relating to goods supplied in the course of treating a patient or animal by a medical practitioner, dentist or veterinary surgeon in the lawful practice of his or her profession.

The Order no longer excludes from its labelling requirements professional starter packs provided to patients through health professionals. This amendment to the labelling Order formalises current requirements for starter packs that are applied through the approval process.

1(3), 1(4) and 1(5)

Applications and exemptions – relating to commencement dates and transitional provisions

These clauses specify the dates by which existing products, and products that are the subject of new applications, must comply with TGO 69. Products already on the Australian Register of Therapeutic Goods or the subject of an application made prior to 1 January 2002 have the option of complying with either the new Order (TGO 69) or the existing Order (TGO 48) until 1 July 2004, at which time TGO 48 is revoked. Products that are the subject of an application made on or after 1 January 2002 will need to comply with the new Order (TGO 69).

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2(1) Interpretation – relating to definitions of terms used in the Order

New definitions have been included for: batch number prefix, delivered dose, expiry date prefix, non-proprietary name, proprietary name, registration or listing number, small volume injection, and sponsor.

Definitions for Australian Approved Names List, name and address in respect of a sponsor or supplier, name of an active ingredient, name of an excipient, product name, quantity of the goods, and warning statements have been revised or expanded.

Updated terminology includes: antimicrobial preservative (replaces antimicrobial agent); complementary healthcare practitioner (replaces alternative therapy practitioner), medicine (replaces drug product), and Poisons Standard (replaces Drugs and Poisons Schedules).

These changes provide technical improvement to the Order and do not impose any additional requirements on sponsors.

3(2)(d) Label requirements – relating to particulars to be included on a label. This subclause relates to the excipient ingredients, listed in Schedule 1 to the Order, which must be declared on the label.

The provisions of this subclause have been revised, not only to accommodate an expanded list of excipients that must be declared (details given under Schedule 1 later in this table), but also to allow for grouping of like ingredients under a single name, the introduction of dose or concentration limits below which a declaration is not required, and limitations on the dosage forms on which the declaration is needed. The revisions to this subclause and the Schedule add clarity through highlighting the link between certain excipients and their toxicological effects.

3(2)(n) Label requirements – relating to particulars to be included on a label. This subclause provides for the inclusion of the registration or listing number on the label.

This is a new subclause, but reflects the requirements of regulation 15(1)(b) and (c) of the Regulations. It therefore is not a new requirement.

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3(3)(b) Label requirements – relating to particulars to be included on a main label.

This subclause previously applied only to products with two or more herbal substance ingredients, and allowed the display of active ingredient information for these products to appear on a side or rear panel rather than the main label. This concession now has been extended to products containing two or more vitamins or minerals.

3(4) Label requirements – relating to preparations for ophthalmic use

Requirements here differ from the current requirements only in respect of:

declaration of the proportion of antimicrobial agent in the product (no longer required); and

extension of the requirement for ophthalmic products in resealable containers that do not contain an antimicrobial agent to indicate that the product is for one-time use only and should be discarded afterwards to ophthalmic creams of this type.

3(5) Label requirements – relating to injections other than large volume injections

Requirements here differ from the current requirements only in respect of:

live vaccines are no longer excluded from these requirements (although the requirements for live vaccines differ only in regard to the need for declaration of excipients);

extension of the requirement for inclusion on the label of multidose injection vials that do not include an antimicrobial agent a statement relating to one-time use only, to all injection containers with potential for multi-dose use, such as pre-filled syringes; and

display of the same information on the primary pack in which the goods are contained.

3(6) Label requirements – relating to large volume injections

Subclauses here qualify the requirements for labelling of injections with a volume greater than 100 millilitres. Requirements in TGO 69 differ from current requirements only in respect of:

providing more general guidance on the naming of such products where there is no proprietary name rather than including a prescriptive list of names; and

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no longer requiring the names and quantities of active ingredients and excipients to be shown in descending order of magnitude within each group of chemically similar substances.

3(7) Label requirements – relating to dialysis concentrates

Requirements here differ from the current requirements only in respect of:

clarification of the way in which the quantities of all ingredients are to be expressed; and

inclusion of a requirement that the label indicate the product contains no antimicrobial preservative and is for one-time use only.

3(8) Label requirements – relating to peritoneal dialysis solutions

These are new subclauses and relate specifically to this type of product (previously these products would have been covered by the general provisions and those applying to large volume injections). The requirements standardise how the concentration of the solution is expressed, and specify certain safety-related statements (freedom from bacterial endotoxins, one-time use only and not being for intravenous administration).

3(9) Label requirements – relating to preparations for use on skin or mucous membranes

Requirements here differ from the current requirements in respect of:

declaration of the proportion of antimicrobial agent in the product, which is no longer required; and

clarification that the declaration of the name of any antimicrobial preservative present is required not only on products used on the skin but also on those applied to mucous membranes.

3(10) Label requirements – relating to biological products

The requirements of these subclauses do not differ from those currently in force, but have been amplified to include recombinant products, with the requirement that the label on these include the name of the biological source. This requirement is currently applied administratively and therefore is not new to sponsors.

3(11) Label requirements – relating to small containers

These subclauses allow for reduced labelling requirements on products enclosed in small containers but marketed in an outer pack. Amendment to these requirements provides

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for the reduced labelling requirements where the container has a capacity of 20 millilitres or less, whereas previously the capacity below which reduced requirements applied was 10 millilitres.

3(12) Label requirements – relating to individually wrapped goods

These subclauses allow for reduced labelling requirements on individual dosage units of a product that are separately wrapped or enclosed in a sachet or bag, where such individual units are contained within a fully labelled outer pack. These subclauses largely remain unchanged, although additional dosage forms eligible for reduced labelling on individual sachets or blisters have been added.

3(13) Label requirements - relating to the strip, blister and dial dispenser packs

These subclauses allow for reduced labelling requirements on strip, blister or dial dispenser packs from which dosage units can only be extracted individually, provided these packs are contained within a fully labelled outer pack. These subclauses largely remain unchanged, but have been expanded to include dial dispenser packs.

3(17) Label requirements – relating to plastic ampoules

These are new subclauses and relate specifically to plastic ampoules (previously these products would have been covered by the general provisions and those applying to injections or small containers). The requirements allow for alternative methods of labelling such as embossing, and delineate the information that may be included on connecting strips joining ampoules rather than on individual ampoules under specific circumstances. The subclauses provide for the inclusion of a warning where an incorrect route of administration may be hazardous. They reflect the current industry standard.

3(18) Label requirements – relating to composite packs

This is a new subclause and clarifies that the expiry date to be shown on the outer pack of a product that consists of more than one kind of item is to be the expiry date of the product with the shortest shelf-life.

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4(7) Expression of quantity or proportion of active ingredient in medicines – relating to preparations for injection

Changes in these subclauses are minor and clarify how concentrations should be expressed for particular types or sizes of injections. The current requirement for declaration of excipient concentrations on labels of large volume injections intended for electrolyte replacement, nutritional therapy or plasma volume expansion has been removed.

4(12) Expression of quantity or proportion of active ingredient in medicines – relating to preparations containing trace elements as salts intended as mineral supplements

This subclause has been amended to be less prescriptive in the way in which the quantity of trace elements must be expressed.

4(14) Expression of quantity or proportion of active ingredient in medicines – relating to pressurised metered dose inhalers and dry powder inhalers

The provisions of this subclause have been amplified to accommodate new technologies for the delivery of medicines by inhalation, such as dry powder inhalers. Also the subclause now allows for the British Pharmacopoeial method of expression to take precedence in specified situations.

4(15) Expression of quantity or proportion of active ingredient in medicines – relating to preparations containing biological organisms

This is a new subclause and standardises how the number of organisms in a product is to be expressed on the label.

5(2) Expression of potency in biological products

This is a new subclause requiring that the potency of probiotic biological products be included on labels and standardising how this potency is expressed.

First Schedule Excipients required to be declared on the label of medicines

The content of this Schedule has been amended in the following respects:

inclusion of additional excipients that are to be declared, either for safety reasons such as allergy (peanuts, peanut products, pollen – bee, propolis), or for alerting consumers with specific medical conditions for whom intake may be contraindicated or need to be controlled (phenylalanine, sodium salts, sorbates, sugar alcohols, honey, sulfur dioxide);

excluding some products which are used by specified routes of administration from the requirements;

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grouping substances of the same class, for example different sugars, and allowing a single label declaration under a group name; and

inclusion of concentration limits below which some excipients are not required to be declared.

Prepared by Conformity Assessment Branch

Therapeutic Goods Administration

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PART 4 – ASMI RESPONSE TO GUIDELINE FOR THE LABELLING OF

MEDICINES

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GUIDELINE FOR THE LABELLING OF MEDICINES – ASMI COMMENTS

ASMI will not be making detailed comments to the Guideline for the labelling of medicines (the

Guideline).

Given the limited time available, ASMI has chosen to focus on the draft Order and the RIS Document

instead of making a detailed analysis of a Guideline document which will inevitably require substantial

revision.

Having said that, ASMI makes the following general comments about the Guideline:

The Guideline needs to be clear about its purpose. While it introduces its purpose “to help

sponsors and manufacturers of medicines meet Australian labelling requirements described in

the Therapeutic Goods Order 79 Standard for general requirements for the labelling of

medicines (TGO 79).” it also attempts to address best practice and delineate requirement from

best practice by the use of the words ‘must’ and ‘required’.

The principal function of the Guideline ought to be to assist sponsors to comply with the

requirements in the Order. The Guidelines should not be used to introduce additional

requirements.

ASMI advises that best practice advice can differ significantly between prescription and non-

prescription medicines and urge care in how best practice is written and presented. An

example is Section 5.1 which is in appropriate to non-prescription medicines. From that

perspective best practice guidance might sit within ARGPM, ARGOM or ARGCM, or should be

positioned under subject headings but clearly identified as ‘best practice’ notes.

The Guideline needs to be clear about where it sits within the hierarchy of Labelling

Requirements. The requirements in the Act, the Regulations, the Order, other legislative

instruments (SUSMP & RASML) and the Australian Regulatory Guidelines for Prescription, OTC

and Complementary Medicines.

The Guideline can provide background for the reason for the requirements of the Order. For

example why some excipients are required to be declared on the label.

The Guideline must be careful to provide advice consistent with the wording of the Order. The

Guideline is subordinate to the Order. Where there is an intent for a lesser requirement of

interpretation, it needs to be addressed in the Order and confirmed in the Guideline.

The Guideline should be clear and unambiguous.

The Guideline can easily be updated for currency and refined over time.

ASMI makes the following specific comments about the Guideline:

Consistent with comments made to the TGO 79, Section 4.1 “Salts, hydrates and solvates”

should be re-considered as it has the potential to confuse users of the label and could have a

dramatic impact on sponsors of existing products. The selective disclosure of the free acid or

free base, the counter-ion, and the quantities of either or both will lead to a range of names

and quantities applicable to the same ingredients present at the same concentration. The

allowances extended to the first salt registered in Australia will lapse as soon as a second salt

is registered. The sponsor of the first salt will then have to update all their labelling. It

introduces the recommendation to include the name of the free acid or free base on all panels

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of the primary pack and the salt on one panel – again prescription medicine best practice

applied to all medicines.

Section 10 Optional information is more consistent with the type of information which is

normally provided in ARGOM and ARGCM. We note that ARGPM does not provide advice on

product presentation.

Section 11 “Changes and labels” should not be included in the guideline as this sort of process

information more appropriately belongs in ARGPM, ARGOM or ARGCM.

ASMI remains committed to working with the TGA to ensure that appropriate supporting labelling

guidelines are available to accompany the final published TGO 79. The guidelines should ensure

appropriate support for each classification of medicine (as identified by Parts 1, 2 and 3 of Schedule

10 of the Therapeutic Goods Regulations, 1990.

ASMI suggests that once the Order has been finalised, then the guideline should be developed in

collaboration with industry.