On this page: 1.1 Medicines in Australia must have labels | 1.2 Medicines covered by the Labelling Orders | 1.3 Exempt medicines | 1.4 How information must be displayed | 1.5 What information must be displayed | 1.6 Critical Health Information requirements | 1.7 Main label information | 1.8 Different types of medicine and different types of packaging | 1.9 How to quantify active ingredients

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

There are particular similarities and differences you should note. For example:

• 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 has two schedules and TGO 92 has 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 as these are not packaged with a medicine. The labelling requirements apply to:

• the container
• any other packaging
• any documents that are part of the packaging.

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).
• If your composite pack contains a Schedule 4 or Schedule 8 medicine, the label on the pack must comply with TGO 91.

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 care 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 mm 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 1.5mm.

Text size for active ingredients

It is important that both healthcare 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 3.0 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 contrast 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.

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.

In this section: 1.5 What information must be displayed | 1.5.2 More than one layer of packaging | 1.5.3 Intermediate packaging | 1.5.4 AUST R and AUST L number | 1.5.5 Batch number and expiry date | 1.5.6 Changing sponsor or distributor details | 1.5.7 Substances that must be declared | 1.5.8 Machine-readable code and space for dispensing label | 1.5.9 Warnings

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. 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).

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 itself is in a primary pack, only some of the information specified in sections 8 and 9 must be on the container.

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

The requirement for medicines that are on the ARTG to have on their labels the relevant registration number or listing number 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.

Both of these must be 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.

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

1.5.6 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.

1.5.7 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).

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 to the Orders. 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.

1.5.8 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.

We anticipate that this machine readable code will usually be an International Article Number (EAN) barcode.

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.

The dispensing label space is not required if:

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

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 healthcare practitioners with patient instructions e.g. headings for patient name, dose etc., as described in Appendix L of the Poisons Standard.

1.5.9 Warnings

To ensure their safe use, many medicines require particular information to be communicated to consumers and health professionals.

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 in a number of 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 (as amended from time to time)
• 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.

There are some exemptions to the requirements for tabulated CHI on registered non-prescription medicines - these are detailed in subsection 8(3) of TGO 92.

This requirement doesn't mean you must include additional information on your medicine label. If your label includes tabulated CHI, you can present 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.

Section 9 of the Orders describes the information you must include on the main label. This information must be oriented in the same direction to assist in identifying the medicine easily.

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 as a cohesive unit in a 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.

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 on the same line. 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.

If your medicine name includes the full name of the active ingredient and its quantity, you do not need to duplicate this information on the main label.

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.

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.