Comparing TGO 79 with TGO 69
Changes to the requirements for labelling
medicines
Version 1.0, August 2014
Therapeutic Goods Administration
About the Therapeutic Goods Administration
(TGA)

The Therapeutic Goods Administration (TGA) is part of the Australian Government
Department of Health, and is responsible for regulating medicines and medical devices.

The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management
approach designed to ensure therapeutic goods supplied in Australia meet acceptable
standards of quality, safety and efficacy (performance), when necessary.

The work of the TGA is based on applying scientific and clinical expertise to decisionmaking, to ensure that the benefits to consumers outweigh any risks associated with the use
of medicines and medical devices.

The TGA relies on the public, healthcare professionals and industry to report problems with
medicines or medical devices. TGA investigates reports received by it to determine any
necessary regulatory action.

To report a problem with a medicine or medical device, please see the information on the
TGA website <http://www.tga.gov.au>.
Copyright
© Commonwealth of Australia 2014
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if
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100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>
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Therapeutic Goods Administration
Version history
Version
Description of change
Author
Effective date
V1.0
Original publication
Office of Scientific
Evaluation
August 2014
Comparing TGO79 with TGO 69
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Therapeutic Goods Administration
Contents
Changing label requirements _____________________ 7
Reasons for changing requirements ________________________________________ 8
No changes to the medicines covered _______________________________________ 9
Transition period ______________________________________________________________ 9
Terms used in TGO 69 but not TGO 79 ______________________________________ 9
Changes which will reduce red tape _______________ 9
Grace period for change in sponsor details ________________________________ 9
Labelling small and very small containers _________________________________ 9
Approved product details on labels _______________________________________ 10
Changes to label content _______________________ 10
All medicines _________________________________________________________________ 10
Medicine name to be on at least 3 sides of a carton ------------------------------ 10
Substances to be declared on labels -------------------------------------------------- 10
Quantification of sodium and potassium -------------------------------------------- 11
Declaration of approved routes-------------------------------------------------------- 11
Expiry date ---------------------------------------------------------------------------------- 11
Prescription medicines _____________________________________________________ 11
Machine readable code and space for dispensing label ------------------------- 11
Declaring substances somewhere other than the label ------------------------- 12
Quantity to be on all labels – including medicines for injection -------------- 12
Non-prescription medicines _______________________________________________ 12
Medicine Information panel ------------------------------------------------------------ 12
Use in pregnancy information ---------------------------------------------------------- 12
Homoeopathic medicines ___________________________________________________ 13
Statement describing medicines as homoeopathic ------------------------------- 13
Statement no longer required ---------------------------------------------------------- 13
Homoeopathic potency------------------------------------------------------------------- 13
Expression of quantity or proportion of active ingredients-------------------- 13
Requirement to differentiate homoeopathic and non-homoeopathic active
ingredients ---------------------------------------------------------------------------------- 13
Medicines with specific ingredients _______________________________________ 14
Medicines containing Vitamin A ------------------------------------------------------- 14
Medicines that contain enzymes ------------------------------------------------------- 14
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Therapeutic Goods Administration
Medicines containing herbal material or preparations ------------------------- 14
Medicines applied using specific routes __________________________________ 15
Preparations for the skin or mucous membranes -------------------------------- 15
Medicines for injection ------------------------------------------------------------------- 15
Medicines packaged in a particular way _________________________________ 15
Medicine kits -------------------------------------------------------------------------------- 15
Medicine starter packs ------------------------------------------------------------------- 15
Strip, blister and dial dispenser packs ----------------------------------------------- 16
Composite packs --------------------------------------------------------------------------- 16
Plastic ampoules --------------------------------------------------------------------------- 16
Individually wrapped medicines ------------------------------------------------------ 17
Transdermal patches, intrauterine or implanted drug delivery systems -- 17
Metered dose products ------------------------------------------------------------------- 17
Changes to label formatting _____________________ 18
General requirements of label formatting _______________________________ 18
Uninterrupted names _______________________________________________________ 18
Identification of active ingredients _______________________________________ 18
Direction of text ______________________________________________________________ 18
Font size _______________________________________________________________________ 18
Font size on labels of registered medicines with less than four active ingredients
-------------------------------------------------------------------------------------------------- 19
Font size on labels of registered medicines with at least four active ingredients
-------------------------------------------------------------------------------------------------- 19
Font size on listed medicine labels---------------------------------------------------- 19
Font size on homoeopathic medicine labels ---------------------------------------- 19
Font size on small containers: 2.5 - 25 mL containers --------------------------- 19
Font size on sunscreen containers no bigger than 25 mL ----------------------- 20
Font size on very small containers: no bigger than 2.5 mL --------------------- 20
Other changes to labels ________________________ 20
Effect of opening packaging on readability ______________________________ 20
Labelling intermediate packaging _________________________________________ 20
Labelling delivery devices __________________________________________________ 20
Durable information ________________________________________________________ 20
Unchanged requirements _______________________ 21
Displaying the AUST R or AUST L number ________________________________ 21
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Metric units ___________________________________________________________________ 21
Directions for use and preparation before use __________________________ 21
Dialysis concentrates ________________________________________________________ 21
Comparing TGO79 with TGO 69
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Therapeutic Goods Administration
Changing label requirements
This document compares the new Therapeutic Goods Order 79 (TGO 79) Standard for the
labelling of medicines with the current Therapeutic Goods Order 69 (TGO 69) General
requirements for labels for medicines. TGO 79 is a standard determined by the Minister (or a
delegate of the Minister) under Section 10 of the Therapeutic Goods Act 1989 (the Act).
This document has been prepared to help those who are familiar with TGO 69 quickly see the
differences between TGO 69 and TGO 79. The sections and subsections quoted are those of
TGO 79, unless otherwise specified. To confirm legislative requirements, please check the
legislation itself, and do not rely solely on this document.
This document emphasises the differences in requirements between TGO 69 and TGO 79.
However, many of the regulatory requirements remain unchanged. Other differences between
TGO 79 and TGO 69 include the structure, numbering system and introduction, with the
introduction to TGO 79 providing more contextual information than the introduction to TGO 69.
The use of Supplementary Notes, as included in the first hard copy issue of TGO 69, has been
discontinued.
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Therapeutic Goods Administration
Summary table
New requirements introduced
TGO 79 section
The name(s) of active ingredient(s) in registered medicines with less than
four active ingredients must be in a sans serif font in a minimum text size of
equivalent to 15 point Arial on the front panel directly under the trade name.
section 9(7)(a)
The names of active ingredients in prescription medicines with four or more
active ingredients must be in a sans serif font in a minimum text size of
equivalent to 12 point Arial, so that the active ingredient is prominent and
consistently appearing in the same place compared to other information on a
label.
section 9(8)(a)
Labels of registered non-prescription medicines must provide information in
a consistent order and manner in a Medicine Information Panel.
section 10(20)
Changes to the font size requirements of text on small containers (capacities
between 2.5 and 25 millilitres) and very small containers (capacity 2.5
millilitres or smaller).
sections 10(4),
10(14), 10 (5),
10 (15)
The primary package of prescription medicines must contain a space for the
dispensing label.
section 8(1)(q)
For medicines packed in strips or blister packs, the name (and the names and
strengths of the active ingredients) must appear at least once across every
two dosage units enclosed in the strip or blister, regardless of whether the
strip or blister may be readily detached.
section
10(17)(b)(vi)(c)
The number of excipients that must be declared has increased.
Schedule 1 of
TGO 79
Warnings are now required on labels related to the use of medicines by those
who are, or may be, pregnant.
section 8(1)(k)
Opaque intermediate packaging must be labelled.
section 8(2)
For medicines that are fully enclosed in drug delivery devices, the device
needs to be labelled with information about the medicine.
section 8(3)
Reasons for changing requirements
We are changing labelling requirements to:

further minimise the risk of prescribing, dispensing and self-selection errors

assist consumers to choose appropriate medicines and use them appropriately.
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Therapeutic Goods Administration
No changes to the medicines covered
There are no changes to the medicines covered: both TGO 69 and TGO 79 apply to the same
medicines.
Medicines that are not exempt from TGO 79 must also comply with advertising requirements
specified in the Therapeutic Goods Act 1989 (Division 3 Part 5-1) and the Therapeutic Goods
Advertising Code.
Transition period
The transition arrangements for the labelling of medicines are to be detailed in section 4 of
TGO 79. A three or four year transition period will be provided, with the exact time period being
determined following consultation.
Terms used in TGO 69 but not TGO 79
The following terms are used in TGO 69 but not TGO 79:

date of manufacture

dispensing pack

letter height

medicament for injection

non-proprietary name

proprietary name

product name.
Changes which will reduce red tape
Grace period for change in sponsor details
The reference to the ‘address’ of the sponsor has been changed to the ‘contact details’ of the
sponsor, with a new definition provided of ‘name and contact details of the sponsor’ in section 6.
The name and contact details of the sponsor are required to be on the label. However, if the
name or contact details of the sponsor change, TGO 79 allows a 12 month ‘grace period’ before
the updated information is required to appear on the label [subsection 8(1)(i)]; no such grace
period exists in TGO 69.
This makes labelling requirements more achievable.
Labelling small and very small containers
There have been practical difficulties associated with labelling small containers, with a limited
area available for inclusion of labelling information. TGO 79 has fewer labelling requirements for
small and very small containers (defined in section 6 according to their capacity) provided that
the primary pack is fully compliant.
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Therapeutic Goods Administration
By having achievable labelling requirements, the labels on small and very small containers will
no longer require exemption from compliance with standards under section 14 and 14A of the
Act.
Acceptable font sizes have been reduced for small and very small containers, and less content is
required on the labels of very small containers. Labelling requirements are described for:

injections in small containers: section 10(4)

injections in very small containers: section 10(5)

small containers (not including injections): section 10(14)

very small containers (not including injections): section 10(15).
Approved product details on labels
Sometimes a medicine is registered with unusual approved product details, such as:

a novel storage temperature or condition

unusual units of potency.
Inclusion of these approved product details (defined in section 6) on a label will be compliant
with TGO 79 and will not require an exemption from compliance with standards under section
14 and 14A of the Act.
Changes to label content
All medicines
Medicine name to be on at least 3 sides of a carton
If a medicine is packaged in a primary pack that is a carton, the name of the medicine must
appear on at least three non-opposing sides of the carton [subsection 8(1)(r)]. This means that
medicines can always be stacked so that the name is visible.
Substances to be declared on labels
Substances that must be declared on the labels of medicines are itemised in Schedule 1 of TGO
79. [See also subsection 8(1)(j).]
In addition to the substances in the first schedule of TGO 69, Schedule 1 of TGO 79 includes:

crustacea and crustacean products

egg and egg products

fish and fish products

milk and milk products

potassium salts

sesame seed and sesame seed products
Comparing TGO79 with TGO 69
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Therapeutic Goods Administration

soya beans and soya bean products

sucralose

tree nuts and tree nut products.
These requirements increase public safety because most of these substances have the potential
to cause severe allergic reactions or result in other serious adverse health consequences in
sensitive individuals.
Quantification of sodium and potassium
For sodium and potassium in oral medicines, there is a new requirement for quantification in
milligrams of elemental sodium or potassium. This requirement applies when the daily dose
contains more than 39 mg potassium or more than 120 mg sodium [Schedule 1 of TGO 79].
Providing this information allows individuals to calculate their daily sodium and potassium
intake more accurately.
Declaration of approved routes
The approved route(s) of the medicine need to be stated on the label if the medicine is:

an injection

an infusion

contained in an ampoule but is not an injection.
See subsections 8(1)(o), 9(1)f and 10(18)(b) for more detail.
This differs from TGO 69 in that the route of administration was required for most injections,
but not for inhalations present in ampoules, oral liquids in ampoules or large volume injections.
Declaring the route of administering decreases the likelihood of medication errors.
There is no longer a requirement to include a warning statement when the incorrect route might
be hazardous.
Expiry date
The expiry date prefix is to be in the form: 'EXPIRY DATE', 'EXPIRY', 'EXPIRES', 'EXP. DATE', or
'EXP' or words to this effect, including a mixture of lower and upper case letters. It is no longer
acceptable to use phrases such as: 'Best by' or ‘Best before’ or ‘Use by’ or ‘Use before’.
These requirements are specified in section 6.
Prescription medicines
Machine readable code and space for dispensing label
A machine-readable code (defined in section 6) must be on the label of medicines in schedules 4
or 8 of the Poisons Standard and blood products in Appendix A of the Poisons Standard
[subsection 8(1)(p)].
These medicines must also include a minimum space of 70 x 30 millimetres for the dispensing
label, unless precluded by the dimensions of the primary pack [subsection 8(1)(q)].
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Therapeutic Goods Administration
Neither of these are requirements in TGO 69.
Declaring substances somewhere other than the label
For prescription medicines the substances in Schedule 1 of TGO 79 do not have to be declared on
the label (also the case for TGO 69). However, the acceptable alternative to the label has
changed:

in TGO 79, Schedule 1 ingredients must be declared on a leaflet inserted in the primary pack
if they are not declared on the label [subsection 8(1)(j)]

in TGO 69 it was acceptable to include this information in the Consumer Medicine
Information, which is not necessarily inserted into the primary pack.
This means that there is a guarantee that consumers who purchase the product will have this
information: they do not have to ask for it.
Quantity to be on all labels – including medicines for injection
The quantity of the goods must be stated on all medicine labels [subsection 8(1)(e)]. There are
no exceptions in TGO 79. This contrasts with TGO 69, which provided an exception for goods for
injection if in Schedule 4 or 8 of the Poisons Standard. This is because not specifying the quantity
can lead to medication errors.
Non-prescription medicines
Medicine Information panel
A new requirement of TGO 79 is that registered non-prescription medicines (with the exception
of medicines for injection) must have a Medicine Information panel on the label of the primary
packaging. The Medicine Information panel must also appear on the label of the container if the
container has a capacity greater than 25 millilitres [subsection 10(20)].
The format of the Medicine Information panel is shown in Schedule 2. In addition, there is a
written description of the requirements that apply to the Medicine Information panel in
subsection 10(20).
By providing important information in a consistent order and manner for all registered nonprescription medicines it is anticipated that consumers will find it easier to locate the
information they need to use the product appropriately.
Use in pregnancy information
For non-prescription medicines for oral use, a warning statement is required if the medicine
contains an active ingredient included in category B, C or D in the TGA Prescribing medicines in
pregnancy database [subsection 8(1)(k)].
If the ingredient is in category B1, B2, B3 or C, then the warning statement is:
‘If pregnant or likely to become pregnant, consult a pharmacist or doctor before use’, or
words to this effect.
If the ingredient is in category D, then the warning statement is:
‘Do not use this medicine if pregnant or likely to become pregnant’, or words to this
effect.
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Therapeutic Goods Administration
Homoeopathic medicines
The terminology describing homoeopathic medicines has changed between TGO 79 and TGO 69,
and so the labels for medicines that contain homoeopathic preparations need to change to
reflect the new terminology. The term ‘homoeopathic medicine’ is new, and is defined in
section 6.
Statement describing medicines as homoeopathic
The main label on the container and the main label on the primary pack (if any) must include a
statement:

to the effect that the medicine is a homoeopathic medicine, if all the active ingredients are
homoeopathic preparations [subsection 10(9)]

to the effect that the medicine contains homoeopathic preparations, if the medicine contains
active ingredients that are homoeopathic preparations and other active ingredients that are
not homoeopathic preparations [subsection 10(9)].
This recommended wording (‘homoeopathic medicine’ and ‘contains homoeopathic
preparations’) is new to TGO 79, although wording indicating that the medicine contained
homoeopathic ingredients was required in TGO 69.
Statement no longer required
There is no longer a requirement for homeopathic medicines to state ‘contains homoeopathic
ingredients without approved therapeutic indications’ [subsection 3(15)(b)].
Homoeopathic potency
The definition of ‘homoeopathic potency’ has been updated and clarified in section 6 of TGO 79.
The definition of the ‘name of an active ingredient’ is unchanged, and for homoeopathic
preparations includes the homoeopathic potency in both TGO 69 and TGO 79 (section 6).
Expression of quantity or proportion of active ingredients
The way that the quantity or proportion of active ingredients in medicines containing
homoeopathic preparations has been clarified and expanded in subsection 11(3) to cover single
ingredient homoeopathic medicines.
Requirement to differentiate homoeopathic and non-homoeopathic active ingredients
For medicines that contain active ingredients that are not homoeopathic as well as
homoeopathic preparations, there is now a requirement to clearly differentiate the
homoeopathic active ingredients [subsection 10(10)].
Suggestions on how to make this distinction:

include the statement ‘contains homoeopathic preparations of’ adjacent to the list of
homoeopathic ingredients

preface the name of the homoeopathic active ingredient with the term ‘homoeopathic’.
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Therapeutic Goods Administration
Medicines with specific ingredients
Medicines containing Vitamin A
Medicines containing Vitamin A must now use the word ‘microgram’ when describing retinol
equivalents [subsection 11(2)(j)(v)].
Medicines that contain enzymes
If a medicine contains an enzyme specified in Schedule 3 of TGO 79, then the activity needs to be
expressed in terms of the units specified in Schedule 3 of TGO 79 [subsection 11(2)((j)(i)].
Medicines containing herbal material or preparations
The way that the quantity of an active ingredient is expressed when the active ingredient is a
herbal material or preparation has been clarified in TGO 79. In order to do this, section 6
contains new definitions for:

herbal material: a plant or part of a plant (defined by its botanical scientific name
according to the binominal nomenclature system, including author, and the plant part),
whether fresh or dried, that is whole, fragmented, cut or ground

herbal preparation: an ingredient that is the result of the processing of a herbal material

standardisation: the process in which the content of a specific chemical constituent(s) has
been determined in a herbal material or herbal preparation.
TGO 79 clarifies the intention of TGO 69 by clearly stating that the quantities of herbal
ingredients need to be expressed as both extract weight and equivalent fresh or dry weight. This
enables the consumer to gain meaningful information from the label in relation to the ‘strength’,
‘concentration’ or quantified levels in general, of the herbal ingredients in the medicine.
Where standardisation of a herbal material or preparation is claimed
Where standardisation of the herbal material [subsection 11(2)(j)(ii)(A)] or herbal preparation
[subsection 11(2)(j)(iii)(C)] is claimed on the label of the medicine, then the quantity or
proportion of an active ingredient to be included on a label must be expressed:


for standardised herbal material, as both of the following
–
the minimum dry weight or minimum fresh weight of herbal material
–
the quantity of standardised component(s) in the herbal material
for standardised herbal preparation, all of the following
–
the quantity of herbal preparation in the dosage unit (tablet, capsule etc.)
–
the minimum dry weight or minimum fresh weight of herbal material from which the
preparation is derived
–
the quantity of standardised component(s) in the herbal preparation.
Where no standardisation is claimed
For medicines containing herbal material or preparations with no claims of standardisation, the
quantity or proportion of an active ingredient to be included on a label must be expressed for:
Comparing TGO79 with TGO 69
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
herbal material, as the weight of the herbal material [subsection 11(2)(ii)]

a herbal preparation that is an essential oil, as the quantity of the essential oil [subsection
11(2)(iii)A]

a herbal preparation that is a juice (fresh, concentrated, dry or diluted), as both of the
following:

–
the amount of juice in the dosage unit (tablet, capsule etc.)
–
the minimum dry weight or fresh weight of the herbal material from which the juice
was derived [subsection 11(2)(iii)B].
any other herbal preparation, as both of the following:
–
the amount of the herbal preparation in the dosage unit (tablet, capsule etc.)
–
the dry or fresh weight of the herbal material from which the preparation was derived
[subsection 11(2)(iii)D].
Medicines applied using specific routes
Preparations for the skin or mucous membranes
The name of any antimicrobial preservative needs to be included on the label of preparations for
the skin or mucous membranes [subsection 10(7)].
Medicines for injection
TGO 79 contains specific labelling instructions for medicines for injection. These medicines have
been divided into four categories, which differ from the three categories in TGO 69:

nominal volume greater than 100 millilitres [subsection 10(2)]

nominal volume of 100 millilitres or less [subsection 10(3)]

container capacity of 25 millilitres or less [subsection 10(4)]

container capacity of 2.5 millilitres or less [subsection 10(5)].
The quantity of the medicine must be stated on all labels [subsection 8(1)(e)]. Unlike TGO 69,
there is no exemption for labels of prescription medicines for injection, because this information
is important for the safe use of medicines.
Medicines packaged in a particular way
Medicine kits
TGO 69 did not specify any particular labelling requirements for medicine kits. In TGO 79,
labelling requirements can be found in subsection 10(12) for medicine kits.
Medicine starter packs
TGO 69 did not specify any particular labelling requirements for starter packs. In TGO 79,
labelling requirements can be found in subsection 10(13) for starter packs. Consumers using
Comparing TGO79 with TGO 69
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Therapeutic Goods Administration
starter packs are usually using the medicine for the first time, so it is important that the
medicine is labelled appropriately.
Strip, blister and dial dispenser packs
The labelling requirements for strip, blister and dial dispenser packs (new term: defined in
section 6) differ in TGO 79 if the pack is a calendar pack or contains multiple formulations
[subsection 10(17)].
All strip, blister and dial dispenser packs must be labelled with the following:

name of the medicine

the batch prefix and batch number

the expiry prefix and expiry number

the sponsor name or trademark.
The name and quantity of each active ingredient must be included on strip, blister or dial
dispenser packs if:

the medicine is listed and there is only one active ingredient

the medicine is registered and there are less than four active ingredients.
If the strip or blister pack is not a calendar pack and does not contain multiple formulations,
then, irrespective of whether an individual segment can be readily detached, every two dosage
units the strip or blister must contain the following information:

the name of the medicine

the name and quantity of each active ingredient for listed medicines with one active
ingredient and for registered medicines with less than four active ingredients.
Composite packs
TGO 79 requires the expiry date of the composite pack be the earliest expiry date of the
individual medicines in the pack and the storage conditions of the composite pack to be the most
restrictive storage conditions of the individual medicines in the pack [subsection 10(19)]. This is
because all of the contents of a composite pack need to be stored appropriately.
Plastic ampoules
The labelling of plastic ampoules is described in subsection 10(18). TGO 79 differs from TGO 69
in that:

different sized ampoules are described by container capacity (8 millilitres and 25
millilitres) instead of medicine volume (5 and 20 millilitres)

some labelling requirements have to be on every ampoule, irrespective of whether or not
the seal is broken on detaching an ampoule:
–
name of the medicine
–
name and quantity of active ingredients
–
batch number prefix and batch number
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Therapeutic Goods Administration

–
expiry date prefix and expiry date
–
the approved route(s) of administration followed by the word ‘only’, or warnings about
unapproved routes
labelling requirements not listed above, such as sponsor name and contact details, may be
divided between the ampoule and the connecting strip if the capacity of the ampoule is
8 millilitres or less.
Individually wrapped medicines
Provided that the individually wrapped medicines are in a primary container appropriately
labelled:

tablets, capsules, cachets, pessaries, suppositories, singles doses of powders or liquid, and
transdermal patches need to have batch number and expiry date (as well as name of the
medicine, name and quantity of each active ingredient, and sponsor name or trademark) on
each wrapper, sachet or blister

pastilles and lozenges need only have the name of the medicine on each individual wrapper

a transdermal patch, after application to the patient, must be identifiable by a code, name of
medicine, or name of active ingredient—in TGO 69 the patch was not required to be
labelled.
See subsection 10(16) for more information.
Transdermal patches, intrauterine or implanted drug delivery systems
The label on transdermal patches, intrauterine or implanted drug delivery systems must state
the total quantity of active ingredient in addition to the quantity of active ingredient released in
a specific time period [subsection 11(2)].
Metered dose products
For metered dose products such as pressurised inhalers, dry powder inhalers and nasal sprays,
the quantity of an active ingredient is to be expressed on the label [subsection 11(2)(i)] as:

delivered dose (when this has been established)

metered dose (when subject to a pharmacopoeial monograph)

if delivered dose is unknown and medicine is supplied as discrete dosing units, such as
capsules, then the quantity of active ingredient in a dosage unit.
The definition of ‘delivered dose’ has changed. ‘Delivered dose’ now means the dose delivered to
the patient (section 6), whereas in TGO 69 ‘delivered dose’ included the amount deposited
within the device.
In addition, the name of any antimicrobial preservative needs to be included on the label of
preparations for inhalation and metered nasal sprays [subsection 10(7)].
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Therapeutic Goods Administration
Changes to label formatting
General requirements of label formatting
New requirements for formatting (section 7) require that the information required to be on the
label is:

clearly visible and not obscured

in legible characters

in a colour or colours that contrast strongly with the background.
Uninterrupted names
The name of the medicine on the main label must be presented in a continuous, uninterrupted
manner and not be broken up by additional information, logos, background text or graphics
[subsection 9(2)]. An updated definition of the ‘name of the medicine’ is in section 6.
The name of the medicine and active ingredients must appear as a cohesive unit on the main
label. They must not be separated by any text or graphics and each active ingredient must
appear on the main label on separate lines of text immediately below the name of the medicine
[Section 9(3)].
Exceptions to this cohesive unit apply to:

very small containers [subsections 10(5) and (15)]

medicines with four or more active ingredients [subsections 9(6)(b) and 9(8)]

sunscreens [subsection 9(6)(a)].
Identification of active ingredients
When looking at a label, the names of the active ingredients and how much of each active
ingredient is present must be identifiable from all of the other material on the label [subsection
9(5)]. This can be achieved by a number of means including the size, colour and type of font
chosen.
Direction of text
All text required by TGO 79 to be on the main label must be oriented in the same direction
[subsection 9(4)].
Font size
In TGO 79, unless otherwise specified, all required information is to be displayed in text size of
not less than the equivalent of 6 point Arial [subsection 7(2)(d)].
The way we specify font size has changed. The new approach to describing font size:

applies a minimum size to letters such as ‘a’, digits and symbols such as ‘%’
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Therapeutic Goods Administration

addresses both the height and width of characters.
The font description is not aiming to provide a system of measurement, but to identify a typically
acceptable presentation that can be used as a benchmark and as a comparator to judge the
legibility of fonts. Fonts will be judged by superimposing the labelling text in the font chosen by
the sponsor onto the text in Arial.
The description of font size in TGO 69 is different: the requirements are for letter height
expressed in millimetres, based on letters such as ‘T’, ‘h’ and ‘y’.
Font size on labels of registered medicines with less than four active ingredients
For registered medicines with less than four active ingredients, the names and quantities of the
active ingredients are to be in a sans serif font at least the equivalent of 15 point Arial on the
main label [subsection 9(7)(a)].
Font size on labels of registered medicines with at least four active ingredients
If a registered medicine has at least four active ingredients, the font size of the names and
quantities of active ingredients depends on whether there is a Medicine Information panel:

no Medicine Information panel: in a sans serif font the equivalent of at least 12 point Arial
on the main, side or rear label [subsection 9(8)(a)]

with Medicine Information panel: the equivalent of at least 6 point Arial within the medicine
information panel.
Font size on listed medicine labels
With the exception of listed medicines in small or very small containers, all text on labels of
listed medicines is to be the equivalent of at least 6 point Arial [subsection 7(2)(d)].
Font size on homoeopathic medicine labels
For medicines that contain homoeopathic preparations, the main label on the container and the
main label on the primary pack (if any) must include a statement in text size that is not less than
50% of the text size of the name of the medicine and (in any event) not less than the equivalent
of 8 point Arial:

to the effect that the medicine is a homoeopathic medicine, if all the active ingredients are
homoeopathic preparations [subsection 10(9)]

to the effect that the medicine contains homoeopathic preparations, if the medicine contains
active ingredients that are homoeopathic preparations and other active ingredients that are
not homoeopathic preparations [subsection 10(9)].
Font size on small containers: 2.5 - 25 mL containers
On small containers (2.5 – 25 mL capacity), the font size of the names of the medicine and the
active ingredients is to be at least the equivalent of 8 point Arial and the quantity of active
ingredients is to be at least the equivalent of 6 point Arial, provided that the container is in a
primary pack with font size that complies with TGO 79 [subsections 10(4 and 14)].
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Therapeutic Goods Administration
Font size on sunscreen containers no bigger than 25 mL
For sunscreen preparations in containers no bigger than 25 mL, the text on the container may be
reduced to a text size of not less than the equivalent of 4 point Arial, with the exception of the
sun protection factor, which must be no less than the equivalent of 6 point Arial [subsection
10(11)].
Font size on very small containers: no bigger than 2.5 mL
On very small containers (no bigger than 2.5 mL capacity), the font size of the name of the
medicine is to be at least the equivalent of 6 point Arial with other required information at least
the equivalent of 4 point Arial, provided that the container is in a primary pack with font size
that complies with TGO 79 [subsections 10(5) and 10(15)].
If there is more than one active ingredient, the name of the active ingredients do not need to be
on a very small container, provided that the container is in a primary pack with font size that
complies with TGO 79 [subsections 10(15)(g) and 10(5)(i)].
Other changes to labels
Effect of opening packaging on readability
Information required to be on the label must not be damaged, defaced, destroyed, or removed
when the packaging is opened [subsection 7(3)9b)]. Exceptions are made for blister packs, strip
packs and sachets.
Labelling intermediate packaging
TGO 79 contains requirements for labelling opaque intermediate packaging, such as foil
packaging of a tray of ampoules inside a carton [subsection 8(2)]. There are no such
requirements in TGO 69. Transparent intermediate packaging is exempt from TGO 79
[subsection 5(2)].
Labelling delivery devices
Sometimes a medicine container is fully enclosed within a disposable delivery device that
obscures the label on the container from view. When this is the case, a visible surface of the
delivery device needs to be labelled according to the same requirements that apply to the
container label [subsection 8(3)].
Durable information
The information on the label needs to be printed in such a way that it is durable [subsection
7(2)(c)]. This requirement existed in TGO 69, but ‘durable’ was not defined. ‘Durable’ is now
defined in Section 6 and means that the label will not become illegible before the expiry date
under normal storage conditions.
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Therapeutic Goods Administration
Unchanged requirements
Many requirements are the same in TGO 69 and TGO 79. We have itemised the requirements
below because it may not be immediately obvious that these requirements are unchanged.
Displaying the AUST R or AUST L number
The requirement for the registration number (AUST R number) or listing number (AUST L
number) is specified in regulation 15 of the Therapeutic Goods Regulations 1990, so this
requirement does not need to be in TGO 79.
Metric units
The requirement for the use of appropriate metric units remains unchanged, but is in subsection
11(1) of TGO 79, whereas it is in paragraph 3(1)(c) of TGO 69.
Directions for use and preparation before use
There are no new requirements for ‘directions for use’ or ‘preparation before use’, but these
sections have been reformatted [subsections 8(1)(l) and 8(1)(m)].
Dialysis concentrates
The peritoneal dialysis solution section of TGO 79 [section 10(6)] does not refer to dialysis
concentrates, because haemodialysis solutions are medical devices.
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Therapeutic Goods Administration
PO Box 100 Woden ACT 2606 Australia
Email: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605
http://www.tga.gov.au
Reference R14/710423