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Regulation impact statement: General requirements for labels for medicines
Version 3.0, July 2016
TGOs 91 and 92 are the result of extensive consultation with stakeholder groups.
Over the last 10 years, many stakeholders have alerted the TGA to concerns about labelling and packaging of medicines, including the contribution of naming, labelling and packaging practices to the safety and quality use of medicines. A number of consultation processes have been either partially or solely focussed on their concerns. Most recently the Transparency Review, the Labelling and Packaging of Medicines Review and the Round Table on Safer Naming, Labelling and Packaging of Medicines have all contributed to the consultative process.
In May 2011, the TGA and the ACSQHC jointly hosted the National Round Table on Safer Naming, Labelling and Packaging of Medicines Report on Safety and Quality in Healthcare. The aim of the roundtable was to develop a coordinated approach to improving medicines naming, labelling and packaging in Australia by agreement and coordination amongst key stakeholders. Industry, health professionals, governments and consumer representatives participated. At the meeting the TGA confirmed that a review of medicine labelling and packaging requirements would be conducted. Members made a number of recommendations for improvements to the current regulatory framework with the aim of reducing the risk of confusion of medicines names and labels. The TGA and the ACSQHC undertook to review the recommendations and develop a national approach to reducing the risk of confusing naming and labelling contributing to patient harm.
In July 2011 the TGA commenced a comprehensive review of the labelling and packaging requirements for medicines and an internal working group was established to develop options for the key problems that had been identified with current requirements. These options were further discussed and refined by an invited external stakeholder group comprising healthcare professionals, industry representatives and consumers. This group met in February 2012, marking the start of a collaborative approach with stakeholders to addressing the issues identified with medicine labels. The outcomes of these discussions formed the basis of a consultation paper released later that year.
The TGA medicine labelling and packaging review consultation paper was released for public comment on 24 May 2012. The release of the paper marked the culmination of the previous two years of consultation with the internal working group and key stakeholder groups. The paper outlined a number of proposals to address the identified problems by changing the requirements for labelling of medicines. In response to the consultation, 110 submissions were received from consumers, academics, healthcare professionals and industry. Overall, there was support for the objectives of the review of labelling and the intentions of the recommendations in the consultation paper.
In February 2013, the TGA hosted a major stakeholder meeting to discuss proposed changes that would be required to improve medicines labelling. Stakeholders at this meeting generally agreed that any major changes to the current labelling review should be mandatory and incorporated into a revised TGO, as opposed to best practice guidance. At this time, and after the creation of a joint regulatory agency with New Zealand was abandoned, the TGA proceeded to update labelling requirements separately from the review of medicine packaging.
A first draft of a revised Order (at the time - 'TGO 79') was provided to industry peak bodies in June 2013. Resultant feedback was incorporated as refinements to draft TGO 79.
Between 2013 and mid-2014, draft TGO 79 was further amended and prepared for public consultation.
2014 public consultation
- The consultation RIS .
- Draft TGO 79
- Comparison of TGO 69 and draft TGO 79
- A draft Guideline for the labelling of medicines.
As part of this consultation process, comment was also sought on three proposed policy options outlined in this RIS.
In total, 80 submissions were received from pharmaceutical companies, professional bodies, Government bodies, industry, consumer organisations and members of the public. A list of non-confidential submitters is provided at Appendix A.
The main issues raised in the submissions have been summarised in Table 6, including responses from the TGA on these. It was not possible to individually respond to every comment received; therefore, only significant issues or issues that were raised in several submissions are included in the table.
A summary of major labelling requirements that were amended following the 2014 public consultation is provided at Appendix B.
|Issue||Comment||Response from TGA|
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 or through specific conditions (pdf,132kb) of registration or listing.
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.
|RIS: evidence to support new requirements||While the RIS identified specific concerns with current labelling practices, a number of respondents from both the health professions and industry considered that it did not provide a good level of evidence that the proposed actions would deliver the overall desired level of improvement in public health and safety. Comments particularly applied to low risk, non-prescription products. The comments also drew on the lack of good base level data and the absence of an evaluation plan.||
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.
|RIS: risk based approach (proportionate response)||Feedback noted that the draft TGO 79 presented a 'one size fits all' approach and did not adequately differentiate requirements on the basis of the risk. Many respondents identified problem products, such as those containing paracetamol and ibuprofen, and considered that their risks should be directly addressed, rather than imposing requirements on all medicines in a particular category.||
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.
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.
|User testing||There was high level support, including from industry, for the principles behind the new Order but some comment that proposed label design should be thoroughly tested prior to implementation. Conduct of such testing would assist with an underlying issue - that is the end users of prescription versus non-prescription medicines have different information needs, notwithstanding the common issues such as prominence of active ingredient, etc.||The requirements have been developed in line with existing overseas regulatory frameworks. Specifically with reference to the UK front medicine panel ('active ingredient prominence, active moiety), the USFDA 'Drug Facts' and UK 'critical health information panel'.|
|Active ingredient name & prominence||
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||Industry stakeholders raised concerns about the proposed font sizes and the relationship to/impact on other information already on the front label, including current artwork/branding. Critical issues included strong support for the size of letters to be defined using millimetres rather than point size and also the claim that 15 point font will lower readability & clutter the existing information. There were alternative suggestions that the name of the active ingredient be proportional to the trade name (as per the Poisons Standard requirement). Some respondents maintained that it will be difficult for evaluators to assess compliance on the basis of point size and further noted that font size is not mandated in the UK, EU, and Canada.||
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).
|Medicine Information Panel (MIP)||
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:
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).
|Small containers||The majority of industry submissions detailed concerns about the requirements for small containers (defined as 25ml or less) relating to font sizes, existing information requirements and impact on package size especially re the proposed MIP. A number of respondents proposed a redefinition of 'small container', up to 100ml.||
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.
|Readability & functionality of TGO79||A number of submissions considered the document to be difficult to read & use. Some proposals noted that TGO 79 is written in such a way that the reader needs to look through several sections of the Order to find specific labelling requirements and that this reduces the functionality of the Order. They also noted that TGO 79 as written introduces an additional level of complexity for the design function and, because of this complexity, predicted difficulty in ensuring compliance.||
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.
|Alignment with other regulators||There was a consistent theme for the need to retain alignment with requirements in New Zealand and, where possible, to harmonise with major international regulators (UK, Canada & USA).||
Formal government policy requires international collaboration with major regulators to achieve greater regulatory convergence.
|12-month transition period to allow update for change in sponsorship/distributor details||Some submissions maintain that this is not sufficient time, others that the proposed period is too long.||
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.
|Information required to be on a label must be in a colour or colours contrasting strongly with the background.||
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.
|Exemption provided for batch number and expiry date details from being in a colour or colours contrasting strongly with the background.|
|Options for identification of declarable substances on labels of prescription and related medicines||
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:
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.
|The primary package of prescription medicines must contain a space for the dispensing label.||
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).
|Presentation of the name of the medicine: continuous uninterrupted manner and not be broken up by additional information or background text||Many OTC industry stakeholders held that labelling requirements would impact on trademarks and branding for OTC medicines.||An amendment has been made to allow for a greater degree of flexibility in placement of active ingredient either immediately or adjacent to the name of medicine (if trade mark would be obscured).|
|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.||
Industry concern about extent of information to be included on blister packs.
Non-industry stakeholders concerned about removal of requirement for non-detachable blisters.
|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)||
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.
|This requirement has been deleted due to practicalities and privacy concerns.|
|Omissions from TGO 79||Health professionals & consumer representatives were concerned that the issue of 'look-alike, sound-alike' names was no longer included in TGO 79 (compared with preceding consultations) and that the proposal to establish an advisory committee on labelling and naming issues had also been excluded from this paper.||Look-alike, sound alike names and packaging are issues that can be addressed when either the overall presentation of goods is considered by TGA delegates when deciding to register a new medicine or when a delegate is deciding if the presentation of listed medicines is unacceptable. The TGA has access to several Committees for the provision of high-level, independent expert advice.|
2015 targeted consultation
In 2015, after reviewing submissions from the 2014 consultation and in response to the feedback, draft TGO 79 was restructured into the new draft TGO 91 and draft TGO 92. Certain technical requirements were also revised in response to stakeholder concerns and these were adopted into this new structure.
In October 2015, the revised draft Orders, TGO 91 and 92 and revised guidance were released for targeted consultation. To ensure continuity of engagement, this round of consultation was conducted with the same individuals and organisations that provided comment during the 2014 consultation. Targeted consultation closed in late December 2015.
A total of 38 submissions were received from pharmaceutical companies, professional bodies, Government bodies, industry, consumer organisations and members of the public. A list of non-confidential submitters is provided at Appendix C.
The main issues raised in the submissions are summarised in Table 7, including responses from the TGA on these. As mentioned in response to the 2014 public consultation, it was not possible to individually respond to every comment received; therefore, only significant issues or issues that were raised in several submissions are summarised below.
A summary of major labelling requirements that were amended following the 2015 targeted consultation is provided at Appendix D.
Many of the comments received reiterated concerns raised during the 2014 public consultation. These issues have been described in Table 6 (or Appendix B) and will not be repeated.
|Issue||Comment||Response from TGA|
|RIS: costs||Industry held that the proposed amendments to TGOs would not significantly alter any comments previously made as part of the 2014 public consultation with respect to costings.||
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.
|Active ingredient name, & prominence||
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.
|Option for use of active moiety only (not full approved name) on the main label||
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.
|Definition of small container - 25mL||The majority of industry submissions detailed concerns about the requirements for small containers (defined as 25ml or less) relating to font sizes, existing information requirements and impact on package size especially re the proposed display of critical health information (CHI) (previously MIP). A number of respondents proposed a redefinition of 'small container', even up to 100ml.||A 'medium' size has been 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.|
|The primary package of prescription medicines must contain a space for the dispensing label||
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).
|Labels of registered non-prescription medicines must provide information in a consistent order and manner.||
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
|Industry stakeholders requested further exemptions for certain lozenges, antacids, some hand sanitisers.||
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.
|Medicine name to be on at least 3 sides of a carton||Removal of this requirement from TGO 92 has raised concerns with some non-industry stakeholders.||Maintained. Reiterating the same information on multiple sides of the carton would clutter important health information on non-prescription medicines.|
|Small containers||The majority of industry submissions detailed concerns about the requirements for small containers (defined as 25mL or less) relating to font sizes, existing information requirements and impact on package size especially re the proposed MIP. A number of respondents proposed a redefinition of 'small container', even up to 100mL.||Exemption for small containers has been included where multiple actives can be on the same line and smaller minimum text size used for active ingredients on labels of small containers that do not have outer packaging.|
|Information required to be on a label must be in a colour or colours contrasting strongly with the background.||Industry stakeholders have concern with subjectivity of 'colour contrast' while some non-industry stakeholders have reiterated their concerns regarding this exemption.||
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.
|Individually wrapped goods-requirements batch and expiry date||Industry stakeholders held that 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 requests. (Note: Requests can be made to the TGA seeking the Secretary's consent to import or supply goods that do not comply with a standard, in this case the labelling Order. Consent is granted under the provisions of section 14 of the Act.)||TGO 69 provision in 3(12) reinstated to remove requirement for batch and expiry on unsealed individually wrapped goods.|
|IV bags||Stakeholders identified concerns that many aspects of existing bags would not be compliant with the new labelling Order.||Specific requirements for placement of information on flexible bags containing IV solutions have been drafted to reflect best practice use.|
Other avenues of consultation: Therapeutic Goods Committee
The Therapeutic Goods Committee (TGC) was established under Regulation 34 of the Therapeutic Goods Regulations 1990 (Regulations) to provide advice and to make recommendations to the Minister for Health on the adoption of standards for therapeutic goods and matters relating to the requirements for labelling and packaging. The current membership is available on TGA's website.
In accordance with the Regulations, the TGC was consulted on the (then) draft TGO 79 and guidance in August 2013 and then again in June 2014, prior to public consultation.
Following 2014 public consultation and subsequent decision to split draft TGO 79, the TGC was consulted on the new draft TGO 91 and 92 prior to the 2015 targeted consultation.
On 13 May 2016, TGC were consulted on the amended TGO 91 and TGO 92. At this meeting, the TGC recommended the Orders were suitable for adoption.
- Australian Commission on Safety and Quality in Healthcare, Report on the National Round Table on safer naming, labelling and packaging of medicines, 24 May 2011, page 6-8.
- Australian Government Therapeutic Goods Administration, TGA medicine labelling and packaging review
- Medicines Australia, Generic Medicines Industry Association, Australian Self Medication Industry and the Complementary Healthcare Council.
- The Pharmacy Guild of Australia, the Pharmaceutical Society of Australia, the Society of Hospital Pharmacists of Australia, Council of Australian Therapeutic Advisory Groups, the Royal Australian College of Physicians and the Australian Medical Association.
- Consumer Health Forum of Australia.
- Therapeutic Goods Administration (2014), Consultation: Medicine Labelling
- Therapeutic Goods Administration (2015), Submissions received: Medicine labelling.
- Required Advisory Statements for Medicine Labels (RASML).
- Applying to registered or listed therapeutic goods under Section 28 of the Therapeutic Goods Act 1989 (pdf,132kb), Standard 1995 Specific 1998.
- Applying to registered or listed therapeutic goods under Section 28 of the Therapeutic Goods Act 1989 (pdf,132kb), Standard 1995 Specific 1998
- TGA international engagement strategy 2013-2015.
- Therapeutic Goods Administration (2015), Submissions received: Medicine labelling
- Health Canada, Guidance Document: Labelling of Pharmaceutical Drugs for Human Use, 13 June 2015, section 3.6.3.
- Medicines and Healthcare Products Regulatory Agency, Best practice guidance on labelling and packaging of medicines, June 2003, section 6.4.
- New Zealand Medicines and Medical Devices Safety Authority, Guideline on the Regulation of Therapeutic Products in New Zealand Part 5 Labelling of medicines and related products, Edition 1.5, October 2015, pp 6.
- Therapeutic Goods Committee, February 2016.