Consultation

Option 3 (regulatory option) was the predominant choice amongst stakeholders. There was a clear message that the RIS and the draft TGO 79 both required revision and then further amendment and consultation prior to any implementation.

Option 2 (guidance) was not preferred on the basis of potential lack of compliance, while Option 1 (status quo) was seen as not addressing the issues which are overall well recognised and understood by stakeholders.

Industry preference was for a 4-year implementation (or longer) while health professionals and consumer representation preferred the 2-year implementation option.

The RIS and draft TGO 79 have been revised.

While a 2-year transition period would be optimal for objectives of the review including quick uptake and benefits to be realised, the cost to implement is too high.

A 4-year transition period more closely aligns with typical business as usual activities for the therapeutic goods industry.

A 4-year transition period has been chosen to minimise costs and align with IHIN transition period. During IHIN consultation, some stakeholders indicated that a shorter transition period could lead to a disruption in the supply chain for products that have a short shelf life and potentially result in medicine shortages and risks to public health.

If there are specific safety issues with particular types of goods, these can be dealt with through, for example, amendments to the Required Advisory Statement for Medicine Labels for non-prescription medicines^[101] or through specific conditions (pdf,132kb) of registration or listing.^[102]

Industry and business provided data to support the view that the costings provided in the RIS significantly underestimated the true implementation cost to be incurred. For example, evidence included the hourly/expertise rates the time involved, the number of artwork changes per ARTG entry, the complexity of a label change (and categorisation as a 'major change'), and the frequency of labelling changes.

In some cases industry provided extensive data to show that implementation costs previously accounted for in the RIS did not cover the range of business activities that would be affected, if Option 3 were implemented.

Evidence was also provided that, for some products, new and larger packaging would be required. It was purported that, in the case of relatively low value products, this could affect the viability of production. Some sponsors also indicated that the costs associated with new packaging would ultimately be passed onto the consumer via an increased retail price.

The assumptions and costings detailed in submissions have been considered by the TGA.

Where appropriate, the assumptions and costings have been revised and are the subject of this current RIS.

Evidence from literature has been relied upon to support objectives of the labelling review, where available.

Literature in Australia on the true extent of the problem attributed solely to labelling and packaging is limited. Therefore, much of the evidence outlined in the RIS comes from overseas.

Implementing a risk-based approach would be too difficult to define in a labelling Order. Specific issues of this nature would not be dealt with through a labelling Order update. For example, for a particular active ingredient, issues of this nature can be addressed by applying specific conditions of registration or listing to particular classes of goods.^[103]

Consideration is being given to issues raised on a case-by-case basis. For example the split between prescription and non-prescription medicines has led to greater differentiation between the types of goods (low risk vs higher risk registered goods). This can be seen through exemption for medicine information panel (now called the display of 'critical health information') for low risk products.

There was strong support for increasing the prominence of the active ingredient name. The location under the trade name was also well supported, particularly by the prescription medicine sector; however the OTC sector identified some concerns. There was strong support from healthcare professionals for the active ingredient to be as prominent (or more prominent) as the trade name, with some requests from healthcare groups that it be above the trade name.

Industry raised issues with space constraints with the amount of information required on a label, and in many cases, unlikely to fit on the label.

Prominence of active ingredient retained.

To deal with space constraints issues, an amendment has been made in the non-prescription medicines Order, removing the need for display the salt and quantity of the drug, providing this information is contained within the critical health information section on the rear. These requirements align with the UK.

Font size has been changed to millimetres, per current TGO 69 requirements.

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).

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).

Overall approach was well supported by the range of respondents. However, concern was expressed that the design had not been user tested, in contrast to the presentation used by some companies who already provide a similar panel on the back of the packaging.

There was also some concern with the requirement being applied to low-risk products (hand wash, toothpaste) - and a request for consideration of exemptions. Concern was expressed over 'lack of integration' between information on the front & back panels (i.e. possible duplication of information).

Specific product exemptions have been incorporated into the non-prescription order based on the risks being deemed as low risk or being used directly by health practitioners. This includes:

• medicated throat lozenges, inorganic salt-based antacids where the space available for a label on the primary pack is less than 70cm2 or;
• the medicine is intended for use as a skin antiseptic by a healthcare professional as either hand-hygiene preparation or patient pre-operative preparation.

Criteria for exemptions was combination of pack size (overdose risk), low risk actives and intended use (no 'course of treatment', occasional relief/symptomatic relief.

Greater degree of flexibility of MIP label requirements retained, consistent with north American requirements, for better international alignment.

Regarding formatting, MIP format has been removed from the schedule of Order and requirements have been moved up higher in order (i.e. no longer contained in special requirements section).

Specific details are also provided in guidance (e.g. examples).

An exemption has been made for small containers where multiple actives can be on the same line.

Also, as described above, low risk medicines with a label size of less than 70cm² no longer require an MIP.

To improve readability (and based on the need to consider different risk levels for different products) the TGO was divided into two separate Orders for prescription and non-prescription medicines, TGO 91 and TGO 92.

Changes to formatting and the arrangement of sections have been made.

Noted.

Formal government policy requires international collaboration with major regulators to achieve greater regulatory convergence.^[104]

A 12-month transition period has been maintained.

The definition of 'name and contact details' in section 6 has also been revised to align with the Poisons Standard, plus reference to website and email as possible additional information.

Industry stakeholders have concerns with subjectivity of 'colour contrast' and requested an exemption to this contrast allowing expiry and batch number on blister packaging to be permitted, given the high expense of imposing this requirement and inconsistency with international practice.

Health professionals strongly advocate the need for important information to be in a colour contrasting with the background.

Many industry stakeholders raised issues with the inclusion of a leaflet inserted into the primary pack to disclose schedule 1 declarable excipients, citing unacceptable costs for sponsors when the information is already included in the Consumer Medicine Information (CMI).

Some speciality health groups also provided feedback on specific schedule 1 excipients (gluten, lactose), for example, the inconsistency between schedule 1 and Australian Food Standards Code.

A full review of schedule 1 declarable excipients is beyond the scope of this labelling review.

However, to align with Food Standards Australia New Zealand, a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more.

A number of issues have been taken into account including difficulties in including the CMI in the pack; concerns about the ability to fit all required information on medicine labels; the need for consumers to have consistent access to important safety information; the levels of risk associated with different excipients and dosage forms; the merits of determining threshold levels for excipient concentrations; and the possibility of greater harm resulting from medicines not being taken because of a perceived risk from exposure to certain excipients.

Considering declarable excipients in schedule 1 may pose considerable safety risks to consumers, the prescription medicines Order has been amended to allow a choice of declaring the schedule 1 excipients through:

• declaration [of the specific excipients] on the label; or
• identified by a statement that directs consumers to the CMI.

The point that identifies the declarable excipients is a 'flag' that alerts consumers and initiates a conversation with healthcare practitioners on appropriate medication. It does not necessarily preclude use of the medicine.

Health practitioner groups recommended that a dispensing label space of 80 x 40 mm be mandated, consistent with TGA's best practice guidelines on medicine labelling.

Industry stakeholders maintained that a space of 70 x 30 mm should be maintained, consistent with international best practice.

A dispensing label space of 70 x 30 mm has been maintained, consistent with international best practice.

An exemption has also been made for starter packs and medicines used in a clinical setting (i.e. where self-administration will not occur).

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

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

Healthcare professional groups advocated the need for this requirement, particularly in the emergency setting.

Industry concern about cost including changes to manufacturing processes, inconsistency with overseas requirements and privacy concerns for a patient.

Due to timing and resource constraints, the RIS had not been amended prior to the targeted consultation.

Since the close of targeted consultation, a consultant has revised the costings contained within the earlier RIS. These costings take into account many of the comments received as part of previous consultations, including the need to account for some label changes as 'major.' The revised costings are the subject of this current RIS.

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

Some submissions requested an exemption from minimum text size for medicines requiring dual spelling during the IHIN implementation timeframe. This is due to space constraints for very long names.

Three was also a request that listed medicines containing two or more actives be permitted to list on the side/rear and not the main label.

Proposed exemption for 'dual names' has been adopted. A reduced min. text size of 2.5mm during the IHIN transition period has been drafted. A new Schedule 2 has been added to the Orders and lists the names to which the exemption would apply.

Difficulty for herbal preparations, vitamins and minerals to be included at required text size recognised. TGO 69 requirement 3(3)(b) to be reinstated such that if two or more of these, actives can be included on the side/rear label. This would apply to both registered and listed medicines.

Concerns with lack of harmonisation with NZ.

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

This requirement has been retained. Clarity has been provided to ensure that the active moiety is part of the full Australian Approved Name.

TGA has discussed this matter directly with the NZ regulator, Medsafe. It should be noted that the NZ Government has reviewed the Medicines Act and a Bill in the NZ parliament proposes significant changes including greater recognition of Australian and other international standards for medicines.

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.

The requirement for a minimum space of 70x30 mm has been retained but a recommendation to have a larger space where possible has been included in the best practice guidance.

Clarity provided on when the space should be on the container rather than an outer pack and also an exemption for medicines that are supplied to hospitals (ie. where self-administration will not occur).

Concern regarding no definition of 'MIP'.

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

TGO 92 has been amended to reflect a move away from prescriptive 'box/panel presentation.'

Reference is now made to 'critical health information (CHI)' rather than a 'panel'. CHI has been defined in section 6.

Medicine Information Panel (MIP) requirements for non-prescription medicines

Note: now Display of critical health information

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).

Criteria for exemptions was combination of pack size (overdose risk), low risk actives and intended use (no 'course of treatment', occasional relief/symptomatic relief.

The TGA has taken the opposing views into consideration and recommended, through best practice guidance, that ink be used instead of embossing or debossing. The decision aligns with guidance requirements internationally.^{[106,107,108]}

The Vision Australia colour contrast analyser has been referred to in the best practice section of the guidance to assist sponsors.