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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 D: Summary of major amended requirements made in TGO 91/92 as a result of 2015 targeted consultation

Section 6
Requirement TGO 91/92
(Oct 2015 draft)
Issue Current
(Feb 2016)
Definition of small container - 25 mL TGO 92: Section 6 Industry has identified containers greater than 25mL that would need text size concessions as per current 'small containers'. A 'medium' size is currently being re-drafted for TGO 92 with a capacity of 25-60mL, and smaller text size requirements (2.5 mm on main label and 2.0mm on side/rear panel). Active ingredients can be presented on one line rather than on separate lines on the main label.
Transition period to allow update for change in sponsorship/distributor details

TGO 91 & 92: Section 6

Change to labels must be made within 12 months

Some submissions maintain that this is not sufficient time, others that the proposed period is too long. Maintained.
Section 7
Requirement TGO 91/92
(Oct 2015 draft)
Issue Current
(Feb 2016)
AUST L/AUST R number in the Regulations and not duplicated in the TGOs. TGO 91 & 92: 7(2)(d) Some stakeholders requested that the Orders explicitly refer to the inclusion of AUST R/AUST L on the label. Maintained.
Information required to be on a label must be in a colour or colours contrasting strongly with the background.

7(2)(e)

Exemption for batch number and expiry date details.

Industry stakeholders have concern with subjectivity of 'colour contrast'.

Non-industry stakeholders have reiterated their concerns regarding this exemption.

Maintained.
Section 8
Requirement TGO 91/92
(Oct 2015 draft)
Issue Current
(Feb 2016)
Requirement for tabulated medicine information on registered non-prescription medicines.

TGO 92: 8(3)

Exemptions for certain lozenges, antacids, some hand sanitisers.

Requests for further exemptions

Extend exemptions to all hand sanitisers and also toothpastes.

Requests for exemptions for anti-acne, anti-fungal, corn and callus removers not accepted (for safety reasons).

Options for identification of declarable substances on labels of prescription and related medicines

TGO 91: 8(1)

Option for declaration on the label OR statement referencing CMI

Some submissions identify a concern that this requirement results in the need for a package insert.

Maintained.

Additional information to be provided to confirm that there is not a new requirement for a package insert.

Medicine name to be on at least 3 sides of a carton TGO 91: 8(1)(p) Removal of this requirement from TGO 92 has raised concerns with some non-industry stakeholders. Maintained.
The primary package of prescription medicines must contain a space for the dispensing label.

TGO 91: 8(2)

70 x 30 mm

Exemptions for starter packs and medicines used in a clinical setting.

Health practitioner groups have recommended that a dispensing label space of 80 x 40 mm be mandated.

Further healthcare groups have maintained that a dispensing label space should be required even when it is intended for use only in a clinical setting as it cannot be envisaged that a medicine will only be used in a clinical setting or remain so.

Maintained.
Labels of registered non-prescription medicines must provide information in a consistent order and manner. TGO 92: 8(2)

Concern regarding no definition of 'MIP'.

Request for clarity on the degree of flexibility allowed, especially inclusion of 'other information'.

Maintained.

No definition of MIP to be included. Existing drafting to be amended to reflect move away from prescriptive 'box/panel' presentation.

Reference to a 'MIP' to be replaced by recognition of 'critical health information.'

Section 9
Requirement TGO 91/92
(Oct 2015 draft)
Issue Current
(Feb 2016)
Presentation of the name of the medicine: continuous uninterrupted manner and not be broken up by additional information or background text TGO 91 & 92: 9(2)-(3) Industry have raised concerns that this section as written would impact on trademarks and branding. It has been requested that this be changed to 'best practice'.

Maintained.

A document was circulated to industry peak bodies in March 2016 for comment. The document outlined TGA's rationale for this requirement and general principles for interpreting this requirement. This information will be included in the labelling guidance.

Option for use of active moiety only (not full approved name) on the main label TGO 92: 9(7)

Concerns with lack of harmonisation with NZ

Concern with potential issue of differing requirements between products (e.g. active moiety vs full name on main label) as potentially being confusing to a consumer.

Maintained.
Text size and need for prominence of active ingredients

Less than four active ingredients:

  • TGO 91: 9(5)(a)
  • TGO 92: 9(5)(a)

Four or more active ingredients:

  • TGO 92: 9(6)

Industry have raised concerns of lack of available space on the main label with proposed text size, and issues around long active ingredient names.

Non-industry stakeholders have maintained the need for prominence of active ingredients compared to the medicine name to help consumers distinguish the active ingredient from brand name.

Maintained.

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.

The name(s) of active ingredient(s) in listed medicines with less than four active ingredients must be on the front panel directly under the trade name.

TGO 92: 9(6) and 9(7)

<4 actives: main label, (Aust R - NLT 3.0 mm)

>= 4 actives: side/rear panel, (Aust R - NLT 2.5 mm)

Industry concern that many medicines will not comply due to text size requirement.

Request that Aust L with 2 or more actives, side/rear and not main label.

New definition of 'medium container' size (see above).

Difficulty including the required additional information, at required text size, recognised. TGO 69 requirement 3(3)(b) to be reinstated such that if 2 or more herbal, vitamin and mineral active ingredients are present, active ingredient information does not need to be on the main label. This would apply to both Aust R and Aust L.

Haemofiltration and haemodiafiltration solutions TGO 91: 9(7) New type of goods previously considered devices but now considered medicines following recent redesign of sponsor's labels approved by TGA New subsection added.
Section 10
Requirement TGO 91/92
(Oct 2015 draft)
Issue Current
(Feb 2016)
Haemofiltration and diahaemofiltration solutions TGO 91: 10(7) New type of goods previously considered devices but now considered medicines following recent redesign of sponsor's labels approved by TGA New subsection added.
Small containers - specific text size requirements

TGO 91: 10(10)

TGO 92: 10(7)

Submissions have proposed smaller text and less information should be required as currently many small containers will be unlikely to meet the requirements. Maintained.
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, when a dosage unit can be readily detached.

TGO 91: 10(13)(c)

TGO 92: 10(9)(c)

Industry concern about extent of information to be included on blister packs.

Non-industry stakeholders concerned about removal of requirement for non-detachable blisters.

Maintained.

Relevant parts of Section 10 in each Order are being re-drafted to improve clarity on requirements for medicines containing multiple active ingredients.

Ophthalmic use - TGO 69 reference to eye lotions and eye drops

TGO 91 & 92: 10(1)

Only refers to drops

The reference to eye lotions has been removed (equivalent text requirement for eye drops has been retained). Reference to 'eye lotions' has been removed as this is not an approved dosage form. A recent review of the ARTG confirmed that there are goods using this dosage type.
Individually wrapped goods-requirements concerning transdermal patches (previously paragraph 10(16)(d) of TGO 79)

N/A

Draft TGO 79 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.

Non-industry groups have maintained that labelling requirements for transdermal patches should be retained while industry groups previously submitted that imposing this requirement would come at an additional cost (including stability studies) and privacy concerns. Maintained (no requirement).
Individually wrapped goods-requirements batch and expiry date

TGO 91:10(12)

TGO 92:10(8)

Certain goods will not be able to comply with the requirement for batch and expiry on individually wrapped goods. This would result in an increase in section 14 exemptions. TGO 69 provision in 3(12) reinstated to remove requirement for batch and expiry on unsealed individually wrapped goods.
Section 11
Requirement TGO 91/92
(Oct 2015 draft)
Issue Current
(Feb 2016)
Use of the word microgram vs µg

TGO 91/92 : 11(1)

Allows µg in small containers (not primary packs)

Variance of views on allowing use of abbreviation.

Industry raised practicality issues for writing 'micrograms' in full with limited space constraints.

Non-industry groups have raised concerns about potential confusion where µg is permitted on labels.

TGOs contain a note that: The abbreviations 'mg' and 'g' can be used on all labels but 'microgram' should be used in full unless the medicine is in a small container. Then the abbreviation 'µg' may be used.

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