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Medicine labels: Guidance on TGO 91 and TGO 92

Version 2.1, July 2019

15 July 2019

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3. Recommendations and best practice

Part 3 of this Guidance describes best practice principles and provides additional information to assist you in developing medicine labels.

This part of the Guidance is non-mandatory best practice.

In addition to the legislated requirements for medicine labels, there are other features of label design that may affect the quality use of medicines. Some of these are addressed in this Part to assist you in designing a medicine label.

This information is not mandatory and is intended to serve the purpose of improving safe and quality use of medicines.

3.1 General design principles

When designing your label, think about the end user of your medicine. Labels are used by different people under different circumstances. You should consider:

  • age of users
  • target patient group
  • literacy of users
  • visual acuity

This Part of the guidance will assist you with some of these considerations.

3.1.1 User-centred design of labels

You should consider the end user of your medicine and any specific considerations in relation to the type of goods.

For example, if your medicine is to assist people with poor vision, consider using larger text than the minimum requirement.

Inclusion of additional, non-mandatory information may assist consumers in their choice of medicine. Some consumers are interested to know certain additional information about a medicine.

Consumers often ask about:

  • Whether there are any animal products in the medicine
  • Where the medicine was made (see the Australian Competition & Consumer Commission's (ACCC) guidance on country of origin claims)
  • What the packaging is made of (e.g. is the vial stopper made from latex?)
  • Whether the packaging is recyclable
  • Details of the full formulation

You should consider including this type of information on a label.

3.1.2 Latex in medicine packaging

Some medicine packaging components, such as vial stoppers, are made with natural rubber latex. To reduce the risk of anaphylaxis and to assist consumers and health professionals in managing latex allergy, we recommend that all medicines containing rubber in their packaging:

  • state the presence or absence of natural rubber latex on the label; and
  • state the presence or absence of natural rubber latex in the Product Information (PI) and CMI.

For example, if your medicine container has a synthetic latex stopper, you should include the statement 'vial stopper not made with natural rubber latex'.

You should avoid using terms such as 'latex-free'.

3.1.3 Colour contrast

Colour contrast is an important tool in ensuring legibility of text for consumers, particularly for those who experience visual impairment.

The Vision Australia colour contrast analyser can be used to assist you in determining whether your proposed text is acceptable. This is available on the Vision Australia website.

Batch number and expiry date

Although not required by the Orders, you should consider printing the batch number and expiry date details where this would improve legibility. Legibility of embossed batch and expiry is particularly difficult on clear or translucent packaging. If the batch and expiry details must be embossed, a darkened background is preferred.

3.1.4 Colour

We recommend the use of colour to help differentiate medicines within a sponsor’s medicine line, but it should not be the only element that is used. Colour differentiation is different from colour coding (see sections 3.1.3 and 3.1.5 of this guidance).

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Our recommendations with respect to colour are similar to those of the FDA Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (pdf,608kb)*.

3.1.5 Colour differentiation

We recommend using colour to make features on a medicine label stand out and help distinguish one item from another. In some circumstances, colour can be used to bring attention to:

  • the name of the medicine
  • the strength of the medicine
  • important precautions.

We recommend that you:

  • use fonts that are of similar size and style for all the words in the medicine name
  • only use different colours for certain components of the medicine name when it is useful to enhance the differentiation of the medicines within a range.
Using other aspects in addition to colour

Individuals can perceive colours differently, some people are colour-blind and colours can look different in different lighting conditions. For these reasons, if colour was the only element used to distinguish medicines within a sponsor's medicine line it may be difficult or confusing to identify the goods and we may consider this to be unacceptable under section 3(5) of the Act.

We recommend that other features such as font type, size and shape are also used to distinguish medicines.

See 3.4.1 of this guidance for information about colour differentiation for prescription medicines.

3.1.6 Colour coding

Colour coding is where colour is used to designate a specific meaning. However, because colour coding has contributed to medication errors in the past, it needs to be used with care. When colour is used as a shortcut to identifying a medicine, people sometimes don't read the label and this leads to mistakes.

We recommend that:

  • Colour coding is only used when this coding has already been established on TGA-approved labels or is a requirement specified in the Orders.
  • Where colour coding is used on a medicine label, it should be applied to all labels and packaging, such as the immediate container and the primary pack.

3.1.7 Use of capital letters

The ARTG entry often uses uppercase letters for the name of the medicine. However this is purely an administrative practice, and does not mean that the name appearing on the label needs to match the letter case entered in the ARTG.

  • It is at the sponsor's discretion whether to use upper or lower case for the name of the medicine on the label.
  • Care should be taken with all-capital text because it is often harder to read.

Example

ARTG certificate name: 'THERAPAIN CHILDREN'S CHEWABLE paracetamol 250 mg tablets blister pack (reformulation)'.

Label name can be:

  • 'Therapain Children's Chewable', or
  • 'Therapain children's chewable', or
  • 'THERAPAIN CHILDREN'S CHEWABLE' (use of all capitals not recommended)
Use of sentences

We recommend using sentences (starting with a capital letter) to present the information on your label. Use a mix of upper and lower-case letters.

You should only use all-capital letters when they are mandated by other regulatory requirements, such as RASML.

3.1.8 Use of Braille and other languages

Text in languages or characters other than English may also be included on labels, as long as the information:

  • is true and correct
  • does not breach legislation on content that is permitted on medicine labels (such as the Therapeutic Goods Advertising Code)
  • does not impact the readability of required information.

If your label includes text or characters from another language, you should ensure that:

  • this does not cause clutter or overcrowding of the label
  • the other language text is consistent with the required English language text
  • the label, including the name of the medicine, does not include or imply any additional indications
  • interpretation of the text or characters is valid and appropriate.

3.1.9 Machine-readable code

We recommend that all medicine labels include a machine-readable code, although they are only mandatory for prescription medicines.

You can include information such as batch and expiry details and country of manufacture in a 2D data matrix code. Your label should include a statement to alert users of this information, for example, 'Please scan this code for more information about this medicine'.

3.1.10 QR codes

A Quick Response (QR) code is a type of matrix bar code that can be read on a mobile phone.

You may use QR codes to provide consumers with information relating to the medicine. However we recommend you place it on the back or side panel so it doesn't distract from critical information on the main label.

Considerations when using QR codes

If you include a QR code, we recommend that you include a statement close to the QR code stating its purpose, for example:

  • 'Please scan this code to obtain a copy of the Consumer Medicines Information'
  • 'Please scan this code for more information about this medicine' (only when the information is not the CMI).

If the QR code takes the consumer to the CMI, then we recommend that you include a statement informing patients that the CMI is available from pharmacists or the TGA website.

The QR code may:

  • provide a link directly to the CMI document, which must be up-to-date and consistent with the most recent approved PI document. We prefer you to link to the CMI available from the TGA Business Services (TBS) website.
  • direct the consumer to a company website if the website is acceptable (see 3.1.11 Acceptable web addresses of this guidance), and complies with all advertising restrictions.

3.1.11 Acceptable web addresses

A label may include the address of a company website, a QR code, or other machine readable code that directs users to a company website. The website must comply with the advertising restrictions for that particular medicine type.

To ensure this occurs, we recommend that websites identified on labels are such that:

  • the sponsor has full control over the content
  • the website address is Australian (that is, ends with '.au' or other justified suffixes that reflect Australian ownership of the address)
  • information on the website is consistent with the Therapeutic Goods Advertising Code (or other advertising restrictions that apply to the medicine)
  • information about the medicine (including any direct links from the website) is consistent with information approved by the TGA for that medicine.

3.1.12 Blister strips - frequency of information

In some instances, blister strips are manufactured with perforations (or are marked in some way) to assist the consumer or medical practitioner to detach individual dosage units.

When dosage units are detached, it is important that label information can still be read. To address this, there is a specific requirement for how often critical information must be repeated for blisters or strips where an individual segment containing the dosage unit can be readily detached.

It is recognised that blister strips are often cut up, even if there is no intention for individual dosage units to be supplied in this way. To help ensure the quality and safe use of these medicines, we recommend repeating the required information at least once every two dosage units whenever possible.

We also recommend that the particulars on the label remain visible until the last dose is removed. This may best be achieved using a random display where the information appears frequently across the blister strip.

  • General guidance on prescription medicines in blister strips, see section 3.4.5 of this guidance.
  • Information on the specific legislated requirements relating to blister packs, see Part 2.1 of this guidance.

3.2 Inclusion of additional information on labels

You may include more information on a label than is required by the Orders. However, the additional information must not prevent compliance with the Orders.

3.2.1 Full formulation disclosure

The Orders do not require all excipients to be declared on the medicine label (except for injections). You may choose to include the full formulation details to better inform consumers about their medicines.

Disclosure of excipients

You may wish to declare excipients other than those required by the labelling Orders. If you do this, you will need to justify the specific inclusion of some ingredients and not others - selective disclosure of individual excipients may imply that the excipient contributes to the therapeutic activity of the medicine.

Reference to a colour, fragrance or flavour (e.g. red capsule, strawberry flavour) is generally considered to be acceptable without justification.

3.2.2 Claims about absence of substances

Provided that it is true, you may include a statement on the label that your medicine does not contain certain substances of interest to a particular group of individuals (e.g. gluten free, sugar free, alcohol free, lactose free).

If your formulation includes a proprietary ingredient, check with the manufacturer or supplier to make sure that it does not contain anything claimed to be absent on the label.

You may include a statement that the medicine contains no sugar (e.g. 'sugar free') if the formulation does not include:

  • sucrose, glucose, fructose, maltose or honey
  • other sugars with the potential to increase tooth decay or affect people with diabetes.

Claims about absence of substances are considered promotional statements and are not permitted in the Critical Health Information table.

Do not include statements about the medicine being ‘free from’ an active ingredient that is not in the medicine.

For example, a label for paracetamol should not include a statement that it is free from aspirin, because such statements can cause confusion. They may also breach advertising regulations by implying that the medicine is safer by virtue of being free from the named active ingredient.

3.2.3 Changes in formulation or appearance

To alert consumers, we recommend including the statement 'New Appearance' on the label if your medicine has been marketed in Australia and you change its appearance. A change in appearance might be because:

  • a physical characteristic has changed, such as the introduction of a score line
  • the formulation has changed, resulting in a physical change such as the colour of the tablet.

If the formulation has changed but not the appearance, we recommend including the statement 'New Formulation' on the label.

3.2.4 International labels

If your medicine is supplied in Australia and also exported to another country, you may include overseas company details and product registration numbers if they are required by the importing country.

3.2.5 Bulk packaging

By bulk packaging we mean medicine packaging for commercial distribution and supply in Australia.

We are not referring to packaging used to hold:

  • bulk intermediates during manufacturing
  • bulk finished product prior to packaging and for commercial distribution and supply.

A presentation is considered to be a bulk pack where the number of dosage units enclosed within a container exceeds the number of units considered reasonable for the treatment of one individual for a clinically justified period of time.

We recommend that you label bulk packs with a statement such as: 'For Dispensing Only. Not For Individual Patient Supply'. When labelled like this, bulk packs are exempt from the requirement for child-resistant packaging; see Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (TGO 80) and Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).

3.3 Non-prescription medicines information

3.3.1 Critical health information for listed medicines

Presentation of CHI in a tabulated format is not a requirement for some registered non-prescription medicines or for any listed medicine. However, we recommend that you use this format whenever possible for all non-prescription medicines supplied in Australia. This will assist consumers to become more familiar with CHI, and where to find it.

If you choose to use the tabulated format for CHI on, for example, the label of a listed medicine, display the CHI in the same way that is required for higher risk non-prescription medicines.

Otherwise the medicine's presentation may be considered unacceptable under the requirements of the Act.

Both the best-practice information and mandatory requirements for the display of CHI are co-located in Part 4 of this guidance for ease of reference.

3.4 Prescription medicines information

3.4.1 Expressing names of active ingredients and strength

The name and amount of an active ingredient present in a medicine must be clearly stated on the medicine label to assist in quality use of medicines. This information must accurately reflect the medicine's formulation and may therefore include reference to chemical components such as salts, waters of hydration and solvates.

Active ingredients present as salts, hydrates or solvates

For active ingredients that are present as salts, hydrates or solvates, include the name of the salt, hydrate or solvate form on the main label. It may not be necessary to repeat or emphasise this name elsewhere.

Expressing the strength of a medicine

The strength of the medicine will normally be expressed as the equivalent amount of the active ingredient in the anhydrous free acid or free base form and be consistent with international practice. We recommend the following:

Example Recommendation
Only one salt is registered in Australia and the strength of the medicine is expressed in terms of the free base or the free acid.

Include the name of the salt in brackets, e.g. fluoxetine 20 mg (as hydrochloride).[1]

If the available label space precludes this, you can simply use the name of the free base/acid (e.g. fluoxetine 20 mg) on labels other than the main label.

Your main label must include the name of the salt.

More than one salt is registered in Australia (e.g. erythromycin ethyl succinate and erythromycin lactobionate). Include the name of the free acid or free base with the corresponding counter-ion in brackets on all labels.[1]
The active ingredient is present as the salt of a base or acid and it is established that the strength is labelled in terms of the formulated amount of that salt. Use the name of the salt on all labels (e.g. metformin hydrochloride 500 mg and raloxifene hydrochloride 60 mg).
The active ingredients are present as a hydrate or solvate (such as dapagliflozin propanediol monohydrate), where the strength of the medicine is expressed on the solvent-free basis.

Include the hydrate or solvate in brackets, as in the case for a salt, e.g. dapagliflozin 10 mg (as propanediol monohydrate).

If the available label space precludes this, you may omit the name of the solvate (e.g. dapagliflozin 10mg) on labels other than the main label.

Your main label must include the name of the solvate.

The strength of the medicine is expressed in terms of the hydrated or solvated material. The name of the active ingredient must include this information, e.g. indapamide hemihydrate 2.5 mg.
The active moiety is a quaternary ammonium cation e.g. tiotropium (as bromide monohydrate). The expression of the active ingredient is labelled as per a salt and the strength of the medicine is expressed as the amount of the cation (e.g. tiotropium).
  1. Instead of using brackets for the salt, solvate or hydrate, you may also use a statement such as 'contains dapagliflozin propanediol monohydrate, equivalent to 10 mg dapagliflozin'.
Consistency of labelling active ingredient and strength for both innovator and generic versions

It is also important that the names of active ingredients and the strengths of prescription medicines are consistently labelled for both the innovator medicine and any generic formulation of that medicine. That is, the:

  • references to the name of the active ingredient
  • order of multiple active ingredients (if relevant)
  • expression of the strength of the medicine

is established by the innovator medicine.

Using colour to differentiate strength (prescription medicines)

For medicines that differ in strength, but otherwise have the same name, colour may be used to emphasise the strength, so as to differentiate between different labels. Stronger colours might be used for higher strength medicines and lighter shades might be used for lower strength medicines.

Different colour schemes might also be chosen for the different strengths, for example:

  • Innovator Medicine Name 5 mg (blue colour scheme to denote strength)
  • Innovator Medicine Name 10 mg (green colour scheme to denote strength).

When the innovator medicine uses colour differentiation to distinguish between strengths, we recommend to sponsors of generic medicines to use the same colour scheme as the innovator to differentiate the strengths of their products. A generic of the above example would be:

  • Generic Medicine Name 5 mg (blue colour scheme to denote strength)
  • Generic Medicine Name 10 mg (green colour scheme to denote strength).
Specific recommendations

There are recommendations for use of certain colours for specific medicines. See section 3.4.9 of this guidance.

The recommendation for consistency of colour schemes between innovator and generic medicine ranges applies only to colour features to distinguish on the basis of strength. This consistency should NOT be applied to the entire label presentation as it may result in confusion between goods. This would be considered 'unacceptable presentation' under section 3(5) of the Act.

3.4.2 Fixed Dose Combination products

For combination products, the quantities of the active ingredients should be clearly visible and may be incorporated in the product name, for example, 'XYZ 20/10'. This is particularly important when there are several strengths within a range.

3.4.3 Delivery devices

Delivery devices, such as pressurised metered dose inhalers, have different labelling requirements depending on whether the canister can be removed. See section 2.1.3.

If the canister can be removed from the device, consumers may not be aware of this and not realise that important information is obscured. The CMI should state that the canister can be removed to view the full label.

3.4.4 Pharmacist's dispensing label space

You should leave as much space as possible to allow the pharmacist's dispensing label to be affixed to your medicine without obscuring information already on the pack. Some dispensing systems use labels measuring 80 x 40 millimetres which is larger than the minimum space mandated in TGO 91.

Remember, after the pharmacist has labelled the pack, the following essential information should remain visible:

  • Batch number
  • Expiry date
  • Storage instructions
  • Product name
  • Strength
  • Name of the active ingredient(s)
  • Dosage form
  • Barcode (EAN barcode)
  • Signal headings
  • Warning statements
  • AUST R number

Words to the effect 'Place label here' should be placed in the designated dispensing label space. Ideally, if there are mandatory warning labels required, space should be provided.

Small containers

If the medicine is packaged in a small container (such as eye drops), consider using a cardboard backboard on the primary pack that would allow space for a dispensing label.

3.4.5 Consistency with the Product Information for blister strips

We recommend that the overall design of a blister strip label is consistent with the instructions for prescription medicines that are provided within the PI document. We recommend that you:

  • do not present and sequence doses in ways that do not match the approved usual dosage; for example, if the approved dosing regimen is variable, such as once or twice daily, then the labelling must not imply a fixed dose of twice a day
  • do not number each blister cell in sequence, such that a blister pack containing 28 doses is numbered from 1 to 28; such numbers may be confused for the strength of the oral dosage form or the days of the month - when appropriate, use calendar packs, especially for medicines administered on a chronic basis according to a once-daily dosing regimen.

3.4.6 Starter packs of prescription medicines

There are specific labelling requirements for starter packs of your prescription medicine. The definition of a starter pack that is included in TGO 91 is aligned with that given in the Medicines Australia Code of Conduct Edition 18.

Sizes of starter packs

TGO 91 defines the size of starter packs based on the:

  • most commonly prescribed PBS quantity, or
  • smallest trade pack.

Where it is not practical to produce a ⅓ pack, the smallest trade pack can be used. Examples of this may be ear and eye drops or medicines in small containers. Reasons such as cost or availability are not accepted as being impractical.

Dispensing label space

There are specific labelling requirements for starter packs of your prescription medicine. The definition of a starter pack that is included in TGO 91 aligns with that given in the Poisons Standard.

You may leave this space blank or pre-print it with the relevant headings.

3.4.7 Methotrexate-containing medicines

Methotrexate is sometimes taken once weekly and other times more frequently; this has resulted in medication errors. For medicines containing methotrexate we recommend that you:

  • use the warning 'Check dose and frequency - methotrexate is usually taken once a week'
  • consider packaging methotrexate in indication-specific weekly or daily packs to assist in reducing errors.

3.4.8 Vinca alkaloids-containing medicines

We recommend that you label medicines containing vinca alkaloids prominently with, 'To be given intravenously only' followed by 'Fatal if given by any other routes'.

3.4.9 Potassium for injection or infusion

We recommend that you package all concentrated potassium medicines for injection or infusion in a manner that uniquely identifies them.

Medicines for injection or infusion after dilution

For medicines that are for injection or infusion after dilution that contain potassium, best practice is:

  • for ampoules, include a black block of colour on the 'twist off' tab at the top of the ampoule
  • for ampoules, label the end with 'KCl', or equivalent, in large lettering
  • for vials, the cap of the vial should have a black 'twist off' seal
  • clearly label the containers as 'Potassium Chloride' or the relevant salt
  • include the instruction 'dilute before use'
  • display the strength prominently as both total content in millimoles and strength in millimoles/litre.
Premixed bags

For premixed bags containing potassium, we recommend:

  • use only red lettering for labelling
  • write 'Potassium' in letters vertically on the left hand side of the panel as well as horizontally, both in the largest font used on the label
  • display the words 'Potassium chloride' (or equivalent) in large letters on the label
  • display the strength prominently as both total content in millimoles and strength in millimoles/litre next to the word 'Potassium'
  • provide a clear space at least equivalent to the maximum font size around main description and key information (such as diluent and volume).

3.4.10 Neuromuscular blocking agent-containing medicines

There are specific labelling requirements for medicines that contain neuromuscular blocking agents. These requirements are outlined in subsection 10(8A) of TGO 91. Also see Section 2.3.2 of this guidance.

We recommend that the warning statement is:

  • displayed in greater than the minimum 1.5 mm text size where possible
  • displayed on the main label of the primary pack
  • displayed in a combination of upper case and sentence case (i.e. WARNING: Paralysing agent)
  • the permitted abbreviations are only used if there is insufficient space to include the full warning statement.

Example

A medicine contains rocuronium bromide. 'Rocuronium' is a neuromuscular blocking agent listed in Schedule 3 to TGO 91.

The medicine is:

  • an injection packaged in a 3 mL glass ampoule
  • supplied in an outer carton.

The carton label includes the full warning statement for neuromuscular blocking agents, in black text on a fluorescent red background:

Warning: Paralysing agent

The sponsor chooses to include this warning on the main label of the carton to improve visibility and reduce the risk of medication errors.

Due to constraints of the size of the container label, the full warning statement does not fit, so a shortened version has been used:

Warning: Paralysing agent

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