2. Mandatory requirements - specific medicine types

How your medicine meets the general requirements of section 8 of the relevant labelling Order is related to which requirements in sections 9 and 10 also apply. You should review these sections to determine the specific set of requirements for your medicine.

Section 11 of the Orders sets out general requirements on how information on the label must be expressed. This includes:

• how the quantities or amounts of active ingredients must be identified
• storage conditions.

It also includes specific requirements related to certain types of:

• dosage forms (e.g. transdermal patches, solid dosage forms and liquids)
• active ingredients (e.g. antibiotics and herbal ingredients).

The information in this Part of the guidance has been categorised to assist you in identifying specific subsections of 9, 10 and 11 that apply to your medicine.

2.1 Types of packaging

2.1.1 Blister, strip and dial dispenser packs

There are specific requirements for the information needed on blister, strip or dial dispenser packs that are supplied in a primary pack.

You should be aware that:

• The requirements for listed medicines and registered medicines differ.
• The requirements for all registered medicines are the same, regardless of whether your medicine is prescription or non-prescription.
• There are different requirements for certain types of blister or strip packs.

Information required every two (2) dosage units

Certain information must be repeated at least once every two dosage units if your medicine is supplied in a blister or strip where an individual segment containing a dosage unit can be readily detached.

The required information differs depending on how many active ingredients are in your medicine.

Only the name of the medicine must be repeated every two dosage units if your medicine is:

• a listed medicine that contains two or more active ingredients or
• a registered medicine that contains four or more active ingredients.

Otherwise, in addition to the name of the medicine, details of the active ingredient(s) must also be repeated at least once every two dosage units.

Relevant parts of the Orders

The requirements for blister, strip, or dial dispenser packs that are supplied in a primary pack can be found in:

• TGO 91, subsection 10(14)
• TGO 92, subsection 10(9).

2.1.2 Composite packs and medicine kits

Composite packs and kits are types of therapeutic goods that are defined in the Act. They comprise an outer package that contains more than one kind of medicine. These medicines may or may not be on the ARTG as separate goods.

Text between medicine name and active ingredients

To identify that there are multiple formulations within the composite pack or medicine kit, additional information on the active ingredients must be included on the medicine label. This affects the relationship between the medicine name and the active ingredients on a main label (see subsections 9(3) of TGO 91 and 9(6) of TGO 92).

Number of active ingredients

The total number of active ingredients present in the composite pack or medicine kit determines the location of information on active ingredients (see subsection 9(6) of TGO 91; subsections 9(6) and 9(7) of TGO 92).

Composite packs and medicine kits may contain two or more different formulations that share a common ingredient. These should be counted as demonstrated below:

Composite packs

Medicines within a composite pack must be either combined before being administered or be taken in a particular sequence to achieve the intended therapeutic effect.

Where the composite pack contains medicines that are already on the ARTG as 'separate and distinct' goods:

• the individual components may retain their original AUST R or AUST L number on their respective packaging, use the new composite pack AUST R/L number or not include any AUST R/L number. To avoid confusion, if the individual component labels are to include the AUST R/L number of the composite pack, care should be taken to indicate that this number is in fact the AUST R/L of the composite pack and not that of the individual component.
• the outer package of the composite pack must be labelled with the new ARTG number (AUST R or AUST L) for that pack.

Relevant parts of the Orders

• Subsection 9(3) of both Orders
• TGO 91, subsection 10(16)
• TGO 92, subsection 10(11)

Medicine kits

Under current legislation a medicine kit:

• includes at least one medicine that is on the ARTG
• does not include therapeutic devices.

The medicine kit itself is required to also be on the ARTG.

A package, and therapeutic goods in the package, constitutes a kit only if together they do not constitute a composite pack.

Non-prescription medicine kits

There are specific requirements for the label on the package if your medicine is a medicine kit comprising a package with at least one non-prescription medicine in it.

See subsections 9(3) and 10(6) of TGO 92.

Prescription and related medicines

Prescription medicines that are packaged with articles such as syringes or measuring cups are not regulated as medicine kits.

If your medicine includes an article such as these, you must describe it on the medicine label on the primary pack.

See subsection 8(5) of TGO 91.

2.1.3 Delivery devices

When medicine containers are enclosed within a delivery device, such as a canister within a pressurised metered dose inhaler, the label information required under the labelling Orders may be obscured. If the container cannot be removed from the device, then all the information required to be on the container must be on delivery device instead. This is the only situation where the container may not require a label.

This problem is avoided if all the information required to be on the container label is completely visible when the container is enclosed in the delivery device.

See subsections 8(3), 8(4) and 8(5) of TGO 91, subsections 8(4) and 8(5) of TGO 92 and further best practice guidance in Part 3 of this document.

2.1.4 Flexible intravenous (IV) bags

We recognise that large volume flexible bags are often labelled with text in different orientations. This is done to ensure quality and safe use of these medicines when delivered intravenously.

See subsection 9(7) of TGO 91 for the specific requirements for main labels on flexible bags.

There are also requirements for the expression of the quantity or proportion of active ingredients often included in IV bags. See subsections 11(2) and 11(6) of TGO 91.

2.1.5 Individually wrapped medicines

Large volume flexible bags are often labelled with text in different orientations. This is done to ensure quality and safe use of these medicines when delivered intravenously.

The specific requirements depend on:

• the type of dosage unit (for example, lozenges, suppositories, herbal tea bags)
• whether the medicine is prescription or non-prescription.

Relevant parts of the Orders

The requirements for individually wrapped medicines that are supplied in a primary pack can be found in:

• TGO 91, section 10(13)
• TGO 92, section 10(8)

2.1.6 Medium containers

If your medicine is non-prescription and it is in a container with a capacity of 60 millilitres or less, but is not in a 'small container', TGO 92 defines it as being in a 'medium container'.

See section 6 of TGO 92 for the definition of 'medium container'.

Medicines with more than one active ingredient

Medicines that

• include more than one active ingredient, and
• are supplied in a medium container

are not required to state the information about each active ingredient on separate lines on the main label. This applies to both the container and the associated primary pack.

See subsection 9(3) of TGO 92.

Medium container without additional outer packaging

Medicines supplied in medium containers without further outer packaging (i.e. a new primary pack), the name(s) and quantity information for the active ingredient(s) in the medicine can be displayed on the main label in a text size smaller than otherwise required under section 9.

See subsection 9(7) of TGO 92.

2.1.7 Metered dose medicines

If your medicine is packaged to deliver a metered dose (for example, dry powder inhalers or nasal sprays), there are two alternative ways to express the amount of active ingredient on the label.

Specific requirements for the expression of the quantity of the active ingredient in metered dose medicines are in subsection 11(2) of both Orders.

Dry powder inhalers

Since dry powder inhalers do not use 'actuations' it is acceptable to use an appropriate term such as 'per inhalation' when describing the quantity of the active ingredients. The quantity declared must be equivalent to the delivered dose.

2.1.8 Plastic ampoules

The capacity of plastic ampoules, how the ampoule is attached to the connecting strip and the type of medicine in the ampoule will determine how information is displayed on these containers.

The specific requirements are in subsection 10(15) of TGO 91 and subsection 10(10) of TGO 92.

2.1.9 Small containers

If your medicine is in a container with a capacity of 25 millilitres or less, both TGO 91 and TGO 92 define it as being in a 'small container'.

For medicines in small containers that are supplied in an outer primary pack such as a carton, there are some allowances for the label on the container:

• Less information is required on the container label
• This information can be presented in smaller text sizes.

The primary pack of the small container must meet the full requirements of the Orders.

Relevant parts of the Orders

The requirements for small containers that are supplied in a primary pack can be found in:

• TGO 91, subsections 10(4) and 10(11)
• TGO 92, subsection 10(7).

Prescription medicines

Section 6 of TGO 91 defines a 'small container' and excludes 'very small containers' from this definition.

Non-prescription medicines

Medicines that:

• are subject to TGO 92,
• include more than one active ingredient, and
• are supplied in a small container

are not required to state the information about each active ingredient on separate lines on the main label. This applies to both the container and the associated primary pack. See subsection 9(3) of TGO 92.

Medicines that:

• are subject to TGO 92,
• are supplied in a small container, and
• do not have any further outer packaging

can display the name(s) and quantity information for the active ingredient(s) in a smaller text size on the main label. See subsection 9(7) of TGO 92.

2.1.10 Starter packs

Medicines that are starter packs must include:

• a statement to that effect on the label, and
• space for patient and doctor details.

See subsection 10(10) of TGO 91.

2.1.11 Very small containers

If your medicine is a prescription or related medicine supplied in a container with a capacity of 3 millilitres or less, this is defined as being in a 'very small container'. See section 6 of TGO 91.

For medicines in very small containers that are supplied in a primary pack, there are some allowances for the label on the container:

• less information is required on the container label
• this information can be presented in smaller text sizes

See subsections 10(5) and 10(12) of TGO 91.

2.2 Particular routes of administration

2.2.1 Haemofiltration and haemodiafiltration solutions

Haemofiltration and haemodiafiltration solutions have specific requirements for the placement of information on the main label of flexible bags.

There is specific information required to be included on the labels of these types of medicines. See subsections 9(7) and 10(7) of TGO 91.

Haemodialysis fluids used in renal replacement therapy where the movement of solutes is governed by diffusion are classified as medical devices, and are not within the scope of this Order.

2.2.2 Inhalations and nasal sprays

TGO 91 and TGO 92 have the same specific requirements for inhalations and nasal sprays.

Use of antimicrobial preservatives

Medicines for inhalation and nasal sprays must declare the presence of any antimicrobial preservative on the label of the container, and any associated primary pack.

Expressing the quantity or proportion of active ingredients

Medicines for inhalation have different requirements for the expression of the quantity or proportion of an active ingredient. This depends on whether your medicine is delivered as a metered dose or a discrete dosage unit.

See subsection 11(2) of both Orders for these requirements.

Relevant parts of the Orders

• TGO 91, subsection 10(9)
• TGO 92, subsection 10(2)

2.2.3 Injections

TGO 91 applies to medicines for injection. The capacity of the container determines which part of section 10 of TGO 91 applies:

Specific requirements for primary packs

If your injection is in a container with a capacity of less than 25 millilitres or a capacity less than 3 millilitres, the specific requirements in subsection 10(3) apply to the primary pack of your medicine but not the container label.

Injections in special packaging

If your injection is presented in a special type of packaging, additional requirements specified elsewhere in section 10 also apply (e.g. plastic ampoules that have a connecting strip - subsection 10(15)).

Injections requiring preparation before use

Subsection 8(1) of TGO 91 requires that certain preparation steps must be on all injection labels, or on a leaflet inserted in the primary pack of the medicine.

However, you are not required to have preparation steps on the container label where:

• your medicine is an injection in a small or very small container, and
• this information is on the label of the primary pack.

However, we recommend that you include this information if possible.

2.2.4 Ophthalmic medicines

TGO 91 and TGO 92 have the same specific requirements for ophthalmic medicines.

• Labels must declare the presence (or absence) of any antimicrobial preservative (both the container label and any associated primary pack).
• If the medicine is for multidose use, the label must also include specific statements relating to this.

The specific requirements are in subsection 10(1) of both Orders.

2.2.5 Peritoneal dialysis solutions

Specific labelling requirements for peritoneal dialysis solutions are found in subsection 10(8) of TGO 91.

As these medicines are usually large volume injections, there are other relevant requirements in subsection 10(2) and subsection 11(2).

2.2.6 Topical medicines

Topical medicines must declare the presence of any antimicrobial preservative on the label of the container and any associated primary pack.

The definition of 'topical use' can include medicines such as nasal sprays and nasal inhalations. Non-prescription topical medicines have requirements to include specific warning statements such as 'Caution: Not to be swallowed' or 'For external use only' but use of these on nasal medicines can be confusing for consumers. A statement to the effect of 'For nasal use only' can be used instead.

Relevant parts of the Orders

• TGO 91, subsection 10(9)
• TGO 92, subsection 10(2)

Expressing the quantity or proportion of active ingredients

There are also specific requirements on how you must express the quantity or proportion of active ingredients in medicines used on skin or mucous membranes.

See subsection 11(2) of both Orders.

2.2.7 Transdermal patches

There are specific requirements for the expression of the amounts of active ingredients in transdermal patches. You must include:

• the total quantity of active ingredient
• the quantity of active ingredient released in a specific time period

on the medicine label.

See section 11(2) of both Orders.

2.3 Types of active ingredients

2.3.1 Antibiotics

There are specific requirements if you use potency units as a measure of the medicine's activity.

See subsection 11(2) of TGO 91.

2.3.2 Neuromuscular blocking agent-containing medicines

There are specific labelling requirements for medicines that contain an ingredient that is a neuromuscular blocking agent.

See section 6 and subsection 10(8A) of TGO 91.

Ingredients that are neuromuscular blocking agents (including salts thereof) are listed in Schedule 3 to TGO 91.

The warning statement described in subsection 10(8A) of TGO 91 must be displayed on 'fluorescent red' or 'warm red' background colours. The colour identifiers for these background colours are:

• fluorescent red
  • RGB: 253.121.86
  • CMYK: 0.52.65.1
  • Pantone: 811
• warm red;
  • RGB: 245.64.41
  • CMYK: 0.75.90.0
  • Pantone: Warm Red

Container constraints

There are reduced requirements for medicines in particular containers. These are:

• injections in a container with a capacity of 3 mL or less
  • the warning statement can be shortened to 'Warning: Paralyser' or 'Paralyser'.
• plastic ampoules
  • the warning can shortened and be printed in any text colour, with or without the background colour.

See paragraph 10(8A)(b) for details of reduced requirements.

2.3.3 Biological medicines

Biological medicines are defined in section 6 of TGO 91. If your medicine:

• is a vaccine, or
• satisfies all four of the other criteria in that definition

and is not exempt, it must meet the requirements of TGO 91.

There are also specific requirements for biological medicines, see subsection 11(3) of TGO 91.

2.3.4 Herbal medicines

Section 6 of TGO 92 provides specific definitions for herbal materials and herbal preparations to assist you in interpreting the specific requirements of the Order.

The type of herbal ingredient in your medicine determines how you must express the quantity of the active ingredient on the label. The requirements for each type are in subsection 11(2) of TGO 92.

Identifying the active ingredient in herbal medicines

The active ingredient in a medicine is defined in section 6 of TGO 92. This definition must not be interpreted to mean a component within a herbal material or herbal preparation.

In most cases, to correctly identify herbal ingredients, you must state the species name (Latin binomial), plant part and preparation on the label. This is the full approved name as described in the Australian Approved Names List; see Complete approved herbal names for more information.

2.3.5 Additional information for herbal preparations

Your main label needs to include information that relates the amount of active ingredient in your medicine to the amount of herbal material from which it was prepared. See subsection 11(2) of TGO 92.

2.3.6 Where no standardisation is claimed

Herbal material

If the active ingredient in your medicine is a herbal material, its quantity must be expressed as the weight of that material.

Herbal preparation

If the active ingredient in your medicine is a herbal preparation, its quantity must be expressed as the:

• weight of that preparation, and
• equivalent weight of the herbal material from which it was prepared.

2.3.7 Where standardisation is claimed

Standardisation is the process in which the content of a specific chemical constituent(s) has been determined in a herbal material or herbal preparation. Where standardisation of the herbal material or herbal preparation is claimed on the label of the medicine, it affects the way that the quantity or proportion of the active ingredient must be expressed. You should use the term 'minimum' on your label.

Standardised herbal material

If the active ingredient in your medicine is a standardised herbal material, then the quantity of the active ingredient must be expressed as:

• the minimum dry weight or minimum fresh weight of herbal material, and
• the quantity of standardised constituent(s) in the herbal material.

Standardised herbal preparation

If the active ingredient in your medicine is a standardised herbal preparation, then the quantity of the active ingredient must be expressed as:

• the weight of that preparation,
• the minimum weight of the herbal material from which it was prepared, and
• the quantity of standardised constituent(s) in the herbal preparation.

If you include statements on standardised components on your label, you should present this information as clearly as possible. This might include stating the standardised component on a separate line.

2.3.8 Homoeopathic medicines

Section 6 of TGO 92 provides specific terminology to assist in understanding the labelling requirements for homoeopathic medicines:

• homoeopathic medicine
• homoeopathic potency
• the meaning of 'name of an active ingredient' when the active ingredient is a homoeopathic preparation.

Label statement

A statement describing the medicine as homoeopathic is required on the labels of all medicines containing homoeopathic preparations.

The requirements for the wording and location of this information are in subsections 10(3) and 10(4) of TGO 92.

Medicines with both homoeopathic and non-homoeopathic ingredients

If your medicine contains both homoeopathic ingredients and active ingredients in material doses, these must be distinguished on the medicine label.

Section 10(4) of TGO 92 includes some example statements that can be used to differentiate the types of ingredients.

Expressing the quantity or proportion of homoeopathic preparations

Specific requirements for the expression of the quantity or proportion of homoeopathic preparations are in subsection 11(3) of the TGO 92.

2.3.9 Minerals for supplementation

If the formulation of your medicine includes a mineral intended as a supplement (i.e. to increase the user's intake of that mineral), the amount of the mineral element must be declared on the label.

You must state the:

• name of the active ingredient, and
• name and quantity of the element intended for mineral supplementation.

This applies to both prescription and non-prescription medicines.

This requirement applies to all mineral supplements. It does not rely on the inclusion of an explicit statement such as 'for supplementation' (or similar) to be on the label.

You may choose to include the amount of active ingredient in addition to the above information.

2.3.10 Sunscreens

Most sunscreens that are regulated as medicines are listed, rather than registered, on the ARTG.

Listed sunscreens

The names and quantities of the active ingredients do not have to appear on the main label if your sunscreen is a listed medicine.

Subsection 9(6) of TGO 92 provides the alternative of including this information on either the side or rear labels. It does not matter how many active ingredients are in your medicine.

Sunscreens in small containers

If your medicine is a sunscreen and is in a container with a capacity of 25 millilitres or less, some information can be displayed in text sizes smaller than the usual requirements.

These requirements are in subsection 10(5) of TGO 92.

2.3.11 Vitamin supplements

TGO 91 and TGO 92 have the same specific requirements for medicines containing vitamins.

Inclusion of common names of vitamins

Medicines containing an active ingredient that is a vitamin can use the word 'vitamin' (or a suitable abbreviation), together with the common name of that vitamin, on the main label. This additional information does not affect the relationship between the name of the medicine and the name of active ingredients required under subsection 9(3) of the Orders.

The quantity of the active ingredient applies only to the amount of the actual ingredient and not to the amount of the base vitamin.

Relevant parts of the Orders

• TGO 91, subsection 11(6)
• TGO 92, subsection 11(5)

Vitamin A medicines

Medicines containing Vitamin A (or a derivative of Vitamin A) as an active ingredient must express its quantity in microgram retinol equivalents.

See subsection 11(2) of both Orders.

2.3.12 Vitamins, minerals and herbal ingredients

If your medicine contains active ingredients that are vitamins, minerals for supplementation or herbal materials or preparations, you may need to include additional information on your label.

Number of active ingredients

If your medicine includes these types of ingredients, they may be described with additional information as permitted or required by the Orders. This affects when the information on active ingredients can be included on a side or rear panel rather than on the main label (see subsection 9(5) of TGO 92).

Text between medicine name and active ingredients

Similarly, this additional information on the active ingredients may affect the relationship between the medicine name and the active ingredients on a main label (see subsections 9(3) of TGO 91 and 9(6) of TGO 92).