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Regulation impact statement: General requirements for labels for medicines

Version 3.0, July 2016

10 August 2016

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Appendix B: Summary of major amended requirements made in TGO 91/92 as a result of 2014 public consultation

Definitions (section 6)
Requirement Section in TGO 91 Section in TGO 92 changes made following 2014 consultation

Definition of:

  • Certificate of listing (TGO 92)
  • Default standard (TGO 91)
  • Infusion (TGO 91)
  • Listing number (TGO 92)
  • Registration number
  • Stated volume of fill
  • Stated weight
  • Supply
  • Text size
Section 6 Section 6 These are new definitions that have been added to aid readability and to support re-drafted sections of the new draft Orders.

Definition of:

  • Biological medicine (TGO 91)
  • Capacity
  • Label
  • Machine Readable Code
Section 6 Section 6

These are amended definitions that have been added to aid readability.

Note: the definition of a 'label' has been amended because the requirements for 'durability' have been removed.

Warning statements (non-prescription medicines) Section 6 Section 6 Separate definitions have been given in each labelling Order reflecting the different statements that are required for prescription and non-prescription medicines.
Definition of 'distributor' Section 6 Section 6 This definition was added to resolve confusion identified in submissions in relation to the terms 'supply, 'release for supply' and 'supplier'- which were previously undefined.
Definition of 'durable' N/A - definition has been removed

Definition of 'durable' and subsection 7(3) has been removed.

Definition of 'label' has been amended to align with TGO69.

Durable has been added to paragraph 7(2)(c) in relation to the label or labels being durable and in English.

Definition of 'expiry date prefix' Section 6 Section 6 In this definition the words 'USE BY' and 'USE BEFORE' have been re-instated.
Definition of 'name and contact details' Section 6 Section 6

This is a revised definition to align with the Poisons Standard, plus reference to website and email as possible additional information.

For clarity, the provision to allow medicines that are affected by a change to these details to be supplied for a certain period after the change is made and prior to the labels being amended, has been added here instead of inclusion in subsection8(1).

Definition of 'machine readable code' Section 6 Section 6 This definition has been amended to ensure that a (proprietary) non-standard bar code to encode GS1 GTINs cannot be used.
Definition of 'starter pack' (TGO 91) Section 6 and throughout the Order Removed from the Order as not applicable to non-prescription medicines

The definition was amended to align with the Medicines Australia Code of Conduct definition.

It was identified that this definition was not required for non-prescription medicines, hence it has been removed from draft TGO 92.

Definition of 'text size' Section 6 Section 6

This definition has been added as a result of the removal of references to 'text size equivalent to Arial font' from the labelling Orders. The definition is the same as the 'letter height' definition in TGO 69.

Text size is to be measured in millimetres and definition to refer to ascender/descender for consistency with the Poisons Standard.

Definition of 'very small container' Section 6 Removed from TGO 92

Capacity of a 'very small container' has been increased from 2.5mL to 3.0mL.

As these requirements were drafted with regard to medicines such as vaccines, they are not required in the draft TGO 92.

Section 7
Requirement Section in TGO 91 Section in TGO 92 changes made following 2014 consultation
AUST L/AUST R number Paragraph 7(2)(d) Paragraph 7(2)(d) For readability and completeness, the AUST R/AUST L requirement for minimum text size has been added.
Label or labels must be in a colour or colours contrasting strongly with the background Paragraph 7(2)(e) Paragraph 7(2)(e) An exemption has been inserted so that this contrast requirement does not apply to the expiry date and expiry date prefix and the batch number and batch number prefix.
Section 8
Requirement Section in TGO 91 Section in TGO 92 changes made following 2014 consultation
Options for identification of declarable substances on labels of prescription and related medicines Subsection 8(1) N/A

These requirements have been changed to allow Schedule 1 substances to be:

  • declared on the label; or
  • identified by a statement that directs consumers to the Consumer Medicine Information.
Warnings statements related to the use of medicines by those who are, or may be, pregnant. Not applicable Paragraph 8(1)(k)

This is a new requirement from TGO 69.

An additional amendment has been made to exempt medicines containing nicotine for the purpose of smoking cessation.

Medicine name to be on at least 3 sides of a carton Paragraph 8(1)(p) Removed

This requirement has been removed from the non-prescription medicines order to allow for more space for Medicine Information Panel.

This requirement is still contained within the prescription medicines order (paragraph 8(1)(p)).

The primary package of prescription medicines must contain a space for the dispensing label. Subsection 8(2) N/A

Clarity provided on when the space should be on the container rather than an outer pack.

Clarity has been provided on how this space can be used for starter packs.

An exemption for medicines that are supplied to hospitals (i.e. where self-administration will not occur).

Labels of registered non-prescription medicines must provide information in a consistent order and manner in a Medicine Information Panel. Not applicable Subsection 8(2)

Specific exemptions have been added into the non-prescription Order (subsection 8(3)).

Greater degree of flexibility in the format of the Medicine Information Panel.

Specific details to be provided in guidance (e.g. medicine information panel examples).

Disposable delivery device Subsection 8(3) Not applicable

Minor changes to subsection 8(3) in TGO 91 to reflect a common-sense approach where the pharmacist places the dispensing label on the device.

The changes should apply whether single dose or multi-dose, and should apply to inhalation products where the cartridge is fully enclosed in the delivery device.

Section 9
Requirement Section in TGO 91 Section in TGO 92 changes made following 2014 consultation
Proximity of active ingredient name in relation to the trade name and requirement for separate lines Subsection 9(3) Subsection 9(3)

Greater degree of flexibility in placement of active ingredient either immediately or adjacent to the name of medicine (if trademark would be obscured).

Exemption for small containers where multiple actives can be on the same line. Prominence of active ingredient retained.

Use of full Australian approved name on the main label of all medicines Not applicable Subsection 9(7) For medicines that have an MIP, the requirement for display of the full Australian approved name on the main label has been removed. This can only occur if a commonly understood name is used on the main label and that no statement of quantity or amount is displayed; and the full name and quantity of the active ingredient is displayed in the MIP.
The name(s) of active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of not less than 3.0 millimetres on the front panel directly under the trade name. Subsection 9(5) Paragraph 9(7)(a)

Font size has been changed to millimetres.

'Text size' definition has been changed to original TGO 69 wording.

For medicines with fewer than 4 active ingredients, the minimum text size has been reduced from 15 point to not less than 3.0 millimetres (equivalent to 12 point font size).

The names of active ingredients in prescription medicines with four or more active ingredients must be in a text size of not less than 2.5 millimetres. Subsection 9(6) Paragraph 9(7)(b)

Font size has been changed to millimetres.

'Text size' definition has been changed to original TGO 69 wording.

For medicines with 4 or more active ingredients, the minimum text size has been reduced from 12 point to not less than 2.5 millimetres (equivalent to 10 point font size).

Section 10
Requirement Section in TGO 91 Section in TGO 92 changes made following 2014 consultation
Biological medicine labelling requirements (previously subsection 10(8) of TGO 79) Not applicable Not applicable

Section 10(8) has been removed as information can be retained in other documentation such as the PI/CMI for the products. These requirements were felt to be unnecessary duplication.

One of the requirements which are related to sensitivity/allergy issues has been placed into Schedule 1 (antibiotics).

Specific labelling required for starter packs Subsection 10(9) Not applicable The requirement for a space for practitioner/patient details and the requirement for state and territory warnings have both been removed.
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. Paragraph 10(13)(c) Paragraph 10(9)(c) This requirement was introduced in TGO 79 and has now reverted to the requirement specified in TGO 69 (i.e. repetition of at least once every 2 dosage units applies only to blisters where individual dose can be readily detached.
Individually wrapped goods-requirements concerning transdermal patches (previously paragraph 10(16)(d) of TGO 79) Not applicable Not applicable

Paragraph 10(16)(d) previously required that a patch on the skin is identified by a code, or the name of the medicine and strength if more than one medicine, or the name of the active ingredient and how much release in a given time.

This requirement has been deleted due to practicalities and privacy concerns.

Gluten declaration cut off requirements Schedule 1 Schedule 1

A gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more.

This requirement is to align with Food Standards Australia and New Zealand.

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