1. Using the Orders

Labelling requirements depend on the type of medicine, how it is packaged and how it is used. However, there are common principles across all medicine types and therefore a common structure to the Orders.

Figure 1. Structure of both TGO 91 and TGO 92

Notable similarities and differences include:

• Section 7 is the same in both Orders.
• Sections 8 and 9 are different in the two Orders. This reflects the different ways that medicines are used. Consumers need additional information when self-selecting non-prescription medicines and therefore the requirements for these labels are different.
• There are also different types of non-prescription medicines. TGO 92 addresses this and there are different requirements within sections 8 and 9 of this Order for registered non-prescription medicines and listed non-prescription medicines. These differences reflect the low risk nature of listed medicines.
• For example, if you have a listed medicine you are not required to display Critical Health Information (CHI) in the tabulated format that is set out in section 8 of TGO 92.
• Sections 10 and 11 are different in the two Orders. You should review sections 10 and 11 to identify which requirements apply to your medicine, noting that more than one subsection may apply. Additionally, the requirements within sections 10 and 11 may affect how sections 8 and 9 apply to your medicine.
• TGO 91 and TGO 92 each have three schedules.
• Schedules 1 and 2 are the same in both Orders.

1.1 Medicines in Australia must have labels

Labels are intended to communicate information that is critical to the prescriber, dispenser and consumer for the quality use of medicines. If it is difficult to identify medicines, or to locate and understand critical safety information, then medication errors are more likely to occur.

1.1.1 What is covered by the term 'label'?

When we refer to labels, we are not referring to the Consumer Medicine Information (CMI) or the Product Information (PI) documents. The labelling requirements apply to:

• the container
• any other packaging.

In some instances, information that cannot fit on the label is permitted by the Orders to be on a leaflet included in the medicine package (sometimes this is the CMI document). These leaflets will be assessed to ensure that the information fulfils the labelling requirements but are not considered to be a label in themselves. For example, PI/CMIs have specific formatting requirements and, if included as a leaflet, is not required to meet formatting requirements set out in the labelling Orders.

1.1.2 Labels as advertisements

An advertisement includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

Advertising on the labels of medicines needs to comply with part 5.1 of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code.

Most prescription medicines cannot be advertised in Australia. You need to be careful that the labels for prescription medicines and pharmacist-only medicines do not function as advertisements - unless these medicines are in Appendix H of the Poisons Standard.

1.2 Medicines covered by the Labelling Orders

Some types of information must be included on all labels, regardless of whether the medicines are prescription medicines, over-the-counter (OTC) medicines or listed medicines. Other information is particular to specific types of medicines.

To determine what information is required, you must first know which Order applies to your medicine.

Section 3 of each Order sets out the types of medicines covered by that Order.

1.2.1 TGO 91

This Order applies to prescription (and related) medicines, as defined in section 3 of TGO 91. This section refers to Schedule 10 to the Therapeutic Goods Regulations 1990 (the Regulations).

Scheduling under the Poisons Standard

• If your medicine is subject to either Schedule 4 or Schedule 8 to the Poisons Standard, the medicine label must comply with TGO 91 (unless exempt, see section 5 of TGO 91).
• Medical devices that contain substances in Schedule 4, 8 or 9 to the Poisons Standard are not intended to be captured by TGO 91.
• If your composite pack contains a Schedule 4 or Schedule 8 medicine, the label on the pack must comply with TGO 91.

1.2.2 TGO 92

Any medicine that is not subject to TGO 91 must comply with TGO 92, unless exempt.

If your medicine:

• is subject to either Schedule 2 or Schedule 3 to the Poisons Standard, the medicine label must comply with TGO 92.
• is not subject to a schedule to the Poisons Standard, it is likely that the medicine is subject to TGO 92. If in doubt, you will need to review section 3 of both Orders to determine which is applicable.

1.3 Exempt medicines

In some instances, a medicine may fit the criteria set out in section 3 of the Orders but is exempt from the requirements of that Order.

These circumstances are set out in section 5 of each Order and, in general, relate to how the medicine is supplied.

1.4 How information must be displayed

The mandatory information that must be provided on medicine labels, and the way this information is presented, makes an important contribution to the safe and quality use of medicines.

The requirements in section 7 of each of the Orders assist in making medicine labels easier to read and understand. This reduces the risk of errors by health professionals and facilitates consumer access to the information they need.

1.4.1 Text size

You must use a text size of not less than 1.5 millimetres for information that is required to be on medicine labels under the provisions of the Orders.

This minimum text size doesn't apply to a medicine's registration or listing number. The requirement for these to be on medicine labels is discussed in the section 'AUST R and AUST L number' later in this guidance.

Section 6 of the Orders defines text size as the height of:

• upper case (capital) letters, or
• lower case letters having an ascender or descender.

In some specific circumstances, the Orders require certain information to be in minimum text sizes greater than 1.5 millimetres.

Text size for active ingredients

It is important that both health professionals and consumers can easily identify the active ingredients within a medicine. To help achieve this, there are specific requirements in the Orders for the text size you must use for displaying the names and amounts of active ingredients on your label.

Text sizes for registered medicines (prescription and non-prescription)

The names and amounts of active ingredients within a registered medicine must be displayed on the main label in a text size of not less than 3 millimetres. Exceptions to this requirement include where your medicine:

• contains multiple active ingredients, or
• is in a medium, small or very small container.

In these situations, this information may not fit the main label and can be moved to another label or panel. However, certain text height requirements may still apply.

Some examples of these situations are described below but you should refer to either TGO 91 or TGO 92 to determine the requirements for your particular medicine.

1.4.2 Colour contrast

The information required on a medicine label must be in a colour (or colours) that contrasts strongly with the background it's printed on.

Dark text on a light background is easier to read, particularly for people with astigmatism (who make up a significant portion of the population). This is because of the 'halo' effect that occurs when light text is used on a dark background. Black on white may be the most legible contrast combination. There are tools to assist you to measure this (see colour contrast in Part 3 of this guidance).

Highly reflective packaging (such as silver-foiled text) can be difficult to read as the reflection creates poor contrast. In some circumstances, highly reflective packaging will not be considered to meet colour contrast requirements.

Batch and expiry details

Batch and expiry details are often embossed or debossed on medicine labels. If you emboss or deboss these details, they are not required to be printed in ink. However, if you do print the batch or expiry details in ink, it must be in a colour that contrasts strongly with the background.

1.5 What information must be displayed

Certain information must be on any medicine label and this described by the requirements in section 8 of both Orders.

1.5.1 Medicines with more than one label

Many medicines have more than one label or different panels within one label. To reduce unnecessary replication of information in these instances, the Orders:

• define the 'main label' for a medicine (section 6)
• state the most important information you must display on the main label. The remaining required information can be displayed on other labels or panels.

There is one notable exception to this. TGO 91 requires prescription medicines to have the names of the medicine on at least three non-opposing sides of a carton. This allows pharmacists to easily identify medicines regardless of how they are stacked on shelves. This requirement is not relevant to medicines that are self-selected by consumers (so is not included in TGO 92).

See our help card Tips on creating prescription medicine labels compliant with TGO 91 for further information about this example.

1.5.2 More than one layer of packaging

Medicines can also have more than one layer of packaging. If your medicine is supplied in a container which is in an outer primary pack such as a carton, there will be a main label on both the container and the carton. In certain situations the container will not be subject to the full requirements of sections 8 and 9.

Exactly what information is not needed on the container depends on the type of packaging. These requirements are specified in section 10 of the Orders.

1.5.3 Intermediate packaging

Intermediate packaging that obscures the labels of the containers, such as foil on a tray of ampoules inside a carton or a delivery device enclosing a container, must also be labelled - see section 8 of the Orders.

If the information on the label of the container(s) can still be seen and read easily, for example if only one panel of the intermediate packaging is opaque, additional labels are not required.

1.5.4 AUST R and AUST L number

Although not referred to in TGO 91 or TGO 92, the AUST R and AUST L numbers are still required on the labels of medicines that are on the ARTG.

This requirement to have the relevant registration number or listing number on medicine labels is specified in regulation 15 of the Regulations. This prescribes where on a medicine label the numbers must be placed and how they should be displayed.

The AUST R and AUST L number can be:

• oriented in any direction on the label because they are not information required by the Orders
• displayed in a text size that is smaller than the minimum text size otherwise required by the Orders. Section 7 of each Order identifies the legislative requirement for the inclusion of the AUST R or AUST L number on medicine labels.

1.5.5 Batch number and expiry date

Your medicine label must include the medicine's:

• batch number
• expiry date.

Each of these must be immediately preceded by a relevant prefix and examples are provided in section 6 of both Orders. Prefixes that cannot be used for expiry dates are also identified in section 6. Use of a combined batch number and expiry date prefix such as 'Lot/Exp' is generally not acceptable.

To 'precede' the batch number or expiry date, the prefixes must be above or to the left of the information.

See our help card Tips on creating prescription medicine labels compliant with TGO 91 for example explanation.

1.5.6 The name of the dosage form

The name of the dosage form is the dosage form that has been entered onto the ARTG for the medicine.

Some dosage forms are written in reverse order for easy indexing in the TGA eBusiness Code Tables. In most cases, the word order should be changed to achieve plain English on labels, for example, 'tablets, effervescent' should be written 'effervescent tablet' on the label. There are several exceptions such as 'injection, solution' which should not be reversed.

1.5.7 The name of the medicine

The name of the medicine is defined in section 6 of both Orders as the name that appears on the ARTG certificate, with some qualification.

Often additional information appears with a tradename to more fully describe the medicine in the electronic record. Section 6 describes when it is acceptable to omit this information when stating the name of the medicine on a label. For example, additional descriptive information, such as the dosage form or a flavour, may only need to be included to differentiate between medicines in a range. In many instances dosage form or flavour information can be stated elsewhere on the label.

1.5.8 Changing sponsor or distributor details

The name and contact details of the medicine sponsor (or a nominated distributor) must be included on medicine labels.

In some cases, the sponsor or distributor details change during the lifetime of the medicine. For example, there can be a change in the contact details or a change in sponsorship.

Section 6 of the Orders includes a transition period of 12 months in the definition of 'name and contact details'. This allows existing labels, with the original details, to remain compliant with section 8 of the Orders while new labels are created.

If there is a change in sponsorship, the receiving sponsor may choose to supply medicines bearing the relinquishing sponsor's name and contact details on the label for a period of up to 12 months.

1.5.9 Substances that must be declared

You must declare on medicine labels the presence of certain excipients and impurities.

These are mostly found in Schedule 1 to the Orders, but other substances that must be declared include:

• any antimicrobial preservative in preparations for ophthalmic use
• any antimicrobial preservative in preparations for the skin or mucous membranes
• any excipient used in an injection
• some ingredients mentioned in the Required Advisory Statements for Medicine Labels (RASML)

Schedule 1 is not limited to excipients that are deliberately included in the medicine's formulation. In some instances you may need to test your medicine for traces of substances that may be involved in the manufacturing process but are not actual ingredients (e.g. sulfur present in stabilising agents or milk products as growth media).

Some entries in column 1 of Schedule 1 include example names underneath the primary substance name. These are examples only and should not be considered a complete list. You must determine whether any other substances in your medicine fit the definition and need to be declared. Sponsors should speak to their manufacturers about whether any declarable substances are an ingredient or component in the medicine or a known part of the manufacture of the medicine.

For more information about what consumers are expecting on their medicine labels, see the TGA 'Allergens and medicines'^[2] page.

Determining when a substance is present

Not all entries in Schedule 1 include circumstances explaining when the substance doesn't need to be declared.

When there is no cut-off specified in the Schedule 1 entry, sponsors should declare the substance if:

• it has been added during any of the manufacturing processes (even as a manufacturing aid) and there is any likelihood that it remains in the finished goods
• it is a known component, or likely to be a component, of one of the ingredients in the medicine

Sponsors should assess the risk to consumers to determine whether a substance may be present and should be declared.

Tests to determine presence of an ingredient may not be sensitive enough to detect allergens but can be used to provide further information to consumers. Sponsors may choose to include additional information about the allergen on their label, website or Product Information/Consumer Medicines Information documents. Information could include the level of residue detected, the measures taken to remove the substance or how the substance has been used in the manufacturing process. When including additional information, the statement, 'contains x' must still be declared on the label as required by Schedule 1.

If it is unlikely that a substance is present, declarations should not be made simply as disclaimers. Sponsors are not required to introduce tests for all allergens.

Declaring multiple substances

If your medicine has more than one substance that must be declared, these declarations can be combined to form simple sentences e.g. 'contains sugars as lactose' or 'contains aspartame and sulfites'.

You should check all excipients in the formulation to determine if multiple substances need to be declared.

See our help card Tips on creating prescription medicine labels compliant with TGO 91 for example explanation.

Proprietary ingredients

If your formulation includes a proprietary ingredient, check with the manufacturer or supplier to find out if it contains any Schedule 1 substances that must be declared on the label.

Prescription medicines

For prescription medicines, there are two options for the declaration of the substances in Schedule 1. These can be either:

• declared on the label, or
• declared in the CMI and identified by a statement on the medicine's label(s) that directs consumers to the CMI document.

In most cases, medicines that are required to declare substances in Schedule 1 will be expected to include the mandatory declaration on the medicine label to ensure the safe use.

However, it may be permissible to include a more general statement on your label directing consumers to review the CMI for further details. This statement must specifically alert consumers to the presence of a declarable substance in your medicine. This will help ensure that consumers can raise any concerns with their pharmacist or prescribing doctor before taking the medicine.

An example of a general statement that may be permitted is:

'This medicine contains substances that consumers are commonly allergic or sensitive to. For the list of these declarable substances, please refer to the Consumers Medicine Information leaflet, available from your pharmacist or go to www.tga.gov.au.'

Of course, when this statement is used on your labels you must ensure that the CMI is updated to include the required warning statement as set out in Schedule 1.

Specific entries

• Benzoates - this entry refers to benzoic acid and its simple salts. For example, benzoic acid, calcium benzoate, sodium benzoate and potassium benzoate should be declared. More complex esters, such as methyl benzoate, are not captured in this entry.
• Egg - prescription biological medicines are sometimes manufactured using substances such as chicken egg. These substances must be included on the label. Further information can be included on the CMI.
• Hydroxybenzoic acid esters - this entry refers only to parabens with 'hydroxybenzoate' in the Australian Approved Name. Salicylates should not be declared under this entry.
• Phenylalanine - The intention of note 5 of Schedule 1 was to ensure that consumers are aware of medicines that may contain phenylalanine in amounts that are of importance in the context of phenylketonuria (PKU). Ingredients high in protein, such as those mentioned in note 5, may have an impact on patients with PKU who are managing their phenylalanine intake. The intention is not to capture every complex ingredient that may contain phenylalanine as a trace component (e.g. gelatin).
• Pollen - There is no cut-off for pollen specified in Schedule 1, but it is not intended that pollen at background levels in the environment, to which consumers may be exposed in their everyday lives, be declared on medicine labels. The intention is to ensure consumers with pollen allergies are aware of medicines for which there is reasonable cause to suspect pollen may be present. Examples include, bee pollen products or herbal materials in medicines that include flowers.
• Sorbates - this entry refers to preservatives and does not include polysorbates.
• Sugar alcohols - you may include the quantity of the sugar alcohol as part of your declaration. You do not need to include 'contains sugar alcohols' if you choose to use the specific sugar alcohol name.

1.5.10 Machine-readable code and space for dispensing label

Machine-readable code (e.g. barcode)

Medicines covered by TGO 91 must have a machine-readable code on their label, unless they are in starter packs.

This machine-readable code will:

• facilitate electronic aids in dispensing
• act as a means of double-checking that the correct medicine is dispensed.

To be effective, the code must be located where it:

• will not be covered by the pharmacist's dispensing label, and
• can still be scanned after the dispensing label has been affixed.

Multiple machine-readable codes

Medicines may include more than one machine readable code on their packaging. Some of the reasons that multiple machine readable codes may be present on the same package include:

• transitioning to 2D GS1 DataMatrix codes but still requiring linear EAN barcodes to support existing technology
• regulatory requirement for a ‘track and trace’ code from the country of manufacture

Where multiple GS1 machine-readable codes are printed on a medicine package, all codes must encode the same Global Trade Item Number (GTIN). If a linear barcode (EAN-13) is on the pack, the GTIN-14 for the GS1 DataMatrix is created by adding a leading 0 (zero) to the GTIN-13 in the original barcode to ensure that the number remains the same.

Space for dispensing label

Most prescription medicines must also include a minimum space of 70 x 30 millimetres for the dispensing label. See section 10 of TGO 91 to determine whether the space needs to be on the container or primary pack of your medicine.

There are exemptions to this requirement if:

• the medicine is intended for use only in a clinical setting (i.e. supplied directly to hospitals for in-patient use only) or
• it is precluded by the dimensions of the medicine's packaging.

The size exemption does not apply if:

• the label can be redesigned to incorporate the space
• the label includes non-mandatory information that can be omitted to allow inclusion of the space.

If the full dispensing label space cannot fit on the label, it is expected that a smaller space will be included where possible.

Starter packs

If your medicine is a starter pack, you must have a space on the label that can be used to record dispensing details such as the:

• patient's name
• prescriber's name and telephone number
• directions for use
• date of supply.

You may pre-print this space with information to assist health professionals with patient instructions e.g. headings for patient name, dose etc., as described in Appendix L of the Poisons Standard.

1.5.11 Warnings

In addition to the requirements of the Orders, warning statements for medicines are mandated other documents, including:

As sponsor, you must ensure that you are aware of all relevant warnings and advisory statements when designing your label. In many instances, you must use specific wording for this information and it must be in a certain location on the label.

In addition to the requirements of the Orders, warning statements for medicines are mandated by other documents, including:

• the Poisons Standard
• RASML (registered as schedules to the Medicines Advisory Statements Specification (MASS)) (as amended from time to time)
• Conditions of registration or listing
• the Therapeutic Goods (Permissible Ingredients) Determination
• Therapeutic Goods Advertising Code
• State or Territory legislation.

There are some best-practice warnings in Part 3 of this guidance and we strongly recommend you use them if they apply to your medicine.

1.6 Critical Health Information requirements

To ensure their safe use, medicines that are self-selected by consumers must have critical health information (CHI) on their label. Certain registered non-prescription medicines, must display the CHI in a tabulated format so that it is easier for consumers to locate, read and understand.

This requirement doesn't mean you must include additional information on your medicine label. If your label includes tabulated CHI, you can present some information required on the main label in an abbreviated form. See subsection 9(7) of TGO 92.

Part 4 of this guidance provides assistance on how you might present your CHI, including some examples.

1.7 Main label information

The 'main label' is the portion of the label where the name of the medicine is more or most conspicuously shown. This is defined in section 6 of both Orders.

A pack can have more than one main label if there are two or more portions of the label where the medicine name is presented in equal size or prominence.

In general, each layer of packaging also has a main label. Some specific container types do not require all main label information and formatting e.g. blister foils.

Section 9 of the Orders describes the information you must include on the main label. This mandatory main label information must all be oriented in the same direction.

See our help card Tips on creating prescription medicine labels compliant with TGO 91 for example explanation.

1.7.1 Prominence of active ingredients and medicine name

Clear unambiguous identification of medicines is critical in assisting in their safe use. The active ingredients and the name of the medicine must be easily identifiable and legible on a medicine label. To achieve this:

• The medicine name must be complete and clearly discernible (i.e. the complete name all in one place on the label). This will assist in differentiating medicines within a range.
• There must be consistency of location and presentation of active ingredient information.

The main label plays a critical role in communicating this information to medicine users. There are requirements in both Orders (subsections 9(2) and 9(3)) to ensure the prominence of the medicine name and active ingredients on the main label.

The relationship between the name of the medicine and the active ingredients on the label must not be interrupted by other information. However, there are particular medicines where additional information is needed to describe the active ingredients, for example composite packs and also certain types of active ingredients. Requirements for these medicines are included in subsection 9(3) of both Orders. Part 2 of this guidance describes these situations.

The medicine name

When designing your main label, you must:

• display the medicine name in an uninterrupted and continuous manner (the medicine name does not have to be on a single line if the label design or pack dimensions prevent this)
• ensure that the use of trademarks, graphics or additional text do not disrupt the medicine name. Use of the symbols ® and ™ are permitted next to the trade name.
• ensure that no graphics or information interrupt the cohesive unit of the medicine name and the active ingredient.

See our help card Tips on creating prescription medicine labels compliant with TGO 91 for example explanation.

Identifying active ingredients

You must clearly identify the active ingredients present in your medicine by displaying this information in a certain place and in a specific text size. The required location and text size depends on:

• the type of medicine
• the type and size of container
• the type of packaging
• the number and type of active ingredients
• whether you have displayed the CHI in a tabulated format.

To determine the requirements for your medicine, you must read section 9 in conjunction with relevant subsections in section 10 of the Order that applies to your medicine.

To assist consumers in identifying active ingredients, you must place the ingredient name and its quantity or amount together. Text may wrap onto the following line if there are space constraints or if the legibility of the text will be adversely affected by being on the same line e.g. through the use of condensed fonts. If your medicine contains more than one active ingredient, each ingredient must be described on a separate line. The only exceptions are if your medicine is in a small or medium container and TGO 92 applies - see subsections 9(3) and 9(4) of TGO 92.

The following table will assist you to comply with subsections 9(2) and 9(3) of the Orders.

1.8 Different types of medicine and different types of packaging

Some types of medicines, and certain containers, require particular consideration when designing labels.

Section 10 of each Order contains additional requirements, and qualifications to some requirements, for specific medicines or container types.

Your medicine may fit the description of more than one of these types. If so, more than one set of additional requirements will apply.

1.9 How to quantify active ingredients

Labels are to provide consistent strength information for all medicines containing the same active ingredient.

Section 11 of the Orders contains requirements about appropriate metric units and the expression of quantity or proportion of active ingredients, among other aspects of how to express information.

1.9.1 Metric units

You must:

• Express quantities using appropriate metric units, i.e. not in terms of a culinary spoonful (e.g. teaspoon, tablespoon, etc.).
• Always include the quantities of ingredients in the mandated units, in addition to any other dosage related quantities.

If possible, write the units in full.

Some particular classes of goods commonly express the quantities of active ingredients using non-metric units, for example millimoles for electrolytes. These units may be included as additional information on the label. They should not interrupt the main label requirements for expression of the active ingredient and the presentation must not be unacceptable.

Use of abbreviations

Abbreviations are expected to be expressed in standard International System of Units (SI) abbreviations and symbols.

The use of 'μ' may be difficult to see in some print and size formats, and may be misread as 'm' ('mg' rather than micrograms). The word 'microgram' or 'microlitre' must be used in full, unless your medicine is covered by:

• TGO 91 and it is in a small or very small container, or
• TGO 92 and it is in a small container.

In these instances, if there is insufficient space for the full word, use the abbreviation 'μg; or 'μL'.

If there is sufficient space on the primary pack for the full word, but not on the container, then we recommend that you use the abbreviation on the container and 'microgram (μg)' or 'microlitre (μL)' on the primary pack.

Quantity of the active ingredient in a suitable dose

If an article such as a calibrated dropper is packaged with your medicine, you may also include the quantity of the active ingredient in a suitable dose.