comparing tgo 79 with tgo 69: changes to the · web viewa herbal preparation that is an...

Comparing TGO 79 with TGO 69

Therapeutic Goods Administration

Changes to the requirements for labelling medicines

Version 1.0, August 2014

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 decision-making, 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>.

Document title of 22V1.0 Month 2012

http://www.tga.gov.au/


Copyright© Commonwealth of Australia 2014This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <[email protected]>

ConfidentialityAll submissions received will be placed on the TGA’s Internet site, unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked “IN CONFIDENCE”. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet. For submission made by individuals, all personal details, other than your name, will be removed from your submission before it is published on the TGA’s Internet site. In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Version historyVersion Description of change Author Effective date

V1.0 Original publication Office of Scientific Evaluation

August 2014

Document title of 22V1.0 Month 2012

mailto:[email protected]


ContentsChanging 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_________________9Grace period for change in sponsor details__________________________________9

Labelling small and very small containers___________________________________9

Approved product details on labels_________________________________________10

Changes to label content_________________________10All 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

Comparing TGO79 with TGO 69V1.0 August 2014

of 22


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

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--------------------------------------------------------------------16

Strip, blister and dial dispenser packs------------------------------------------------16

Composite packs----------------------------------------------------------------------------16


of 22


Plastic ampoules----------------------------------------------------------------------------16

Individually wrapped medicines-------------------------------------------------------17

Transdermal patches, intrauterine or implanted drug delivery systems---17

Metered dose products--------------------------------------------------------------------17

Changes to label formatting_______________________18General 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__________________________20Effect of opening packaging on readability________________________________20

Labelling intermediate packaging___________________________________________20

Labelling delivery devices____________________________________________________20

Durable information___________________________________________________________20

Unchanged requirements_________________________21Displaying the AUST R or AUST L number__________________________________21

Metric units_____________________________________________________________________21

Directions for use and preparation before use____________________________21

Dialysis concentrates__________________________________________________________21


of 22


Changing label requirementsThis 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.


of 22

http://www.comlaw.gov.au/Series/F2007B00719


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 requirementsWe 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.


of 22


No changes to the medicines coveredThere 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 periodThe 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 79The 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 detailsThe 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 containersThere 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.


of 22


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 labelsSometimes 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 cartonIf 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 labelsSubstances 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


of 22


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 potassiumFor 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 routesThe 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 dateThe 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 labelA 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)].


of 22


Neither of these are requirements in TGO 69.

Declaring substances somewhere other than the labelFor 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 injectionThe 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 panelA 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 non-prescription medicines it is anticipated that consumers will find it easier to locate the information they need to use the product appropriately.

Use in pregnancy informationFor 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.


of 22

http://www.tga.gov.au/hp/medicines-pregnancy.htm

http://www.tga.gov.au/hp/medicines-pregnancy.htm


Homoeopathic medicinesThe 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 homoeopathicThe 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 requiredThere is no longer a requirement for homeopathic medicines to state ‘contains homoeopathic ingredients without approved therapeutic indications’ [subsection 3(15)(b)].

Homoeopathic potencyThe 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 ingredientsThe 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 ingredientsFor 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’.


of 22


Medicines with specific ingredients

Medicines containing Vitamin AMedicines containing Vitamin A must now use the word ‘microgram’ when describing retinol equivalents [subsection 11(2)(j)(v)].

Medicines that contain enzymesIf 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 preparationsThe 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:

herbal material, as the weight of the herbal material [subsection 11(2)(ii)]


of 22


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 membranesThe 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 injectionTGO 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 kitsTGO 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 packsTGO 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 starter packs are usually using the medicine for the first time, so it is important that the medicine is labelled appropriately.


of 22


Strip, blister and dial dispenser packsThe 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 packsTGO 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 ampoulesThe 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

– expiry date prefix and expiry date

– the approved route(s) of administration followed by the word ‘only’, or warnings about unapproved routes


of 22


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 medicinesProvided 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 systemsThe 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 productsFor 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)].

Changes to label formatting

General requirements of label formattingNew requirements for formatting (section 7) require that the information required to be on the label is:

clearly visible and not obscured


of 22


in legible characters

in a colour or colours that contrast strongly with the background.

Uninterrupted namesThe 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 ingredientsWhen 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 textAll text required by TGO 79 to be on the main label must be oriented in the same direction [subsection 9(4)].

Font sizeIn 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 ‘%’

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’.


of 22


Font size on labels of registered medicines with less than four active ingredientsFor 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 ingredientsIf 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 labelsWith 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 labelsFor 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 containersOn 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)].

Font size on sunscreen containers no bigger than 25 mLFor 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 mLOn 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)].


of 22


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 readabilityInformation 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 packagingTGO 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 devicesSometimes 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 informationThe 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.

Unchanged requirementsMany 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 numberThe 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 unitsThe 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.


of 22


Directions for use and preparation before useThere 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 concentratesThe peritoneal dialysis solution section of TGO 79 [section 10(6)] does not refer to dialysis concentrates, because haemodialysis solutions are medical devices.


of 22

Therapeutic Goods AdministrationPO Box 100 Woden ACT 2606 Australia

Email: [email protected] Phone: 1800 020 653 Fax: 02 6232 8605http://www.tga.gov.au

Reference R14/710423

http://www.tga.gov.au/

mailto:[email protected]

comparing tgo 79 with tgo 69: changes to the · web viewa herbal preparation that is an...

Documents