CMA response to TGO 92- Standards for the labels of non-prescription medicines

Transcription

1 CMA response to TGO 92- Standards for the labels of non-prescription medicines Proposed Requirement TGO 92 Text size Text size equivalent to Arial font has been removed from TGO 92. The definition for letter height is the same as the definition in TGO 69. Sec 7 General requirements, including label presentation (2)(e) Labels must be in a colour or colours contrasting strongly with the background Sec 8(2) Labels of registered medicines must provide information in a consistent order and manner in a medicine information panel (MIP) In principle CMA agrees with the change that reverts back to the current TGO 69 definition of text size. This is in comparison to the consultation draft TGO79 that proposed a range of sizes for listed and registered complementary medicines based on Arial point size font. As stated in the CMA 2014 submission, ambiguous and subjective requirements should, on principle, not be included in a legislative instrument. Considering the guidance document elaborates on the proposed requirement, CMA reiterates that we are not aware of there being consumer safety issues of this nature reported for CM products, which are of a lower risk and hence consider the mandatory requirement unjustified. While CMA agrees that directions, warnings and allergen information are all important information, access to other information is also necessary for consumers to make an informed purchasing decision. CMA is of the position that for lower risk registered medicines, such as registered complementary medicines, there should be flexibility to present mandatory information in a clear and concise manner without the constraint of a medicine information panel (MIP). This will minimise cost to the CM industry associated with resizing labels or providing goods in larger container sizes with increased headspace. Section of the Guidance document outlines that a medicine information panel is not required for certain lower risk

2 Proposed Requirement TGO 92 registered medicines these are detailed in subsection 8(2) of TGO 92. Subsection 8(2) however, does not appear to detail specifically what types of lower risk registered medicines would not require a MIP. CMA suggests that this part of the guidance is expanded to include specific guidance that registered complementary medicines are not required to include a MIP. Based on the proposed requirement for a medicine information panel, should the amendment impact registered complementary medicines, mock up labels have been provided to demonstrate that the requirement would necessitate a change to label sizes for complementary medicines, which is considered unjustified. CMA provides at appendix 1 example 1, a mock up of a registered CM provided to demonstrates how the inclusion of a MIP would not work and necessitate labelling complications and medicine container size considerations. Sec 8 (1) (k) (ii) (B) Pregnancy database Sec 9 (2) The name of the medicine on the main label must be presented in a continuous, uninterrupted manner and not be broken up by additional information or background text Sec 9 (5) All text required by this Order to appear on the main label must be orientated in the same direction Requirements related tot his section should be incorporated on an ingredient by ingredient basis within the 26BB list of permissible ingredients instrument. Pregnancy database - Add link CMA considers the proposed requirements to orientate all text in the same direction on the main label, and for medicine names to be presented in a continuous and uninterrupted manner, would not have a meaningful impact upon consumer safety and as such the change is considered unjustified for lower risk medicines. Feedback from our members indicates that medicine labels are often developed as a result of consumer testing. In addition, CMA has not been presented with information that consumers have any usability difficulties with the presentation of information on complementary medicine labels. It is well documented that consumers generally select complementary medicines and non-prescription medicines by brand and category and seek out brands they know. Branding is important for complementary medicines and consumers are familiar with many well-known brands of medicines for general wellbeing, cough and cold, allergy, skincare, and many other categories. Limited label space is therefore an important issue, particularly for certain product and label types. CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 2 of 12

3 Proposed Requirement TGO 92 Such a change would impact upon brand recognition for many companies. As such, CMA considers this as an unjustified change to requirements adding to unnecessary regulatory burden. Industry requires the revised labelling Order to be implemented in a way that avoids impact on branding and does not require consequential changes to dimensions of packs or labels or changes to the packaging details of a medicine. Sec 9 (3) Proximity of active ingredient name in relation to the trade name and requirement for separate lines Sec 9 (7)(a) The names of the active ingredient(s) in registered medicines with less than four active ingredients must be in a text size of no less than 3.0millimeters on the front panel directly under the trade name. Sec 9 (6) If the medicine is intended to be, or is, listed goods: (b) if there are four or more active ingredients in the medicine - the name of every active ingredient, together with the quantity or proportion of every active ingredient, may appear on Since consumers use complementary medicines as part of self-care, the label of these medicines is the primary source of information for consumers. This requirement would mean that a large portion of the label would be used to display the active ingredients. Information on active ingredients is not always the most meaningful aspect in consumer self selection of these goods, rather information sought by consumers tends to be focused around what the product can be used for. Due to the increase in font size, active ingredients will take up a larger portion of label space and there will be reduced space to indicate the intended purpose of the product on the front of pack. If the container and label size are increased as a result of this, without increasing the number of tablets or capsules in the bottle, this could give the consumer a negative perception due to the increased head space of the container. Ultimately this would also impact on rework to shelf space and environmental impact to carbon footprint. CMA provides at appendix 1 example 1, a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations. CMA s position on the number of active ingredients that may appear on the front of a label for listed goods is that TGO 69 requirements be maintained. By imposing [subsection 9(6)(b)] would mean a requirement to go from two or more active ingredients to four or more active ingredients that may be declared on a side panel/label or rear panel/label. This would increase the regulatory cost for these lower risk listed medicines without any evidence of consumer benefit being presented. CMA suggests the following amendment to TGO 92. CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 3 of 12

4 Proposed Requirement TGO 92 a side panel or side label or on a rear panel or rear label. If the medicine is intended to be, or is, listed goods: 6 b) if the medicine is a listed complementary medicine the name of every active ingredient together with the quantity or proportion of every active ingredient, may appear on a side panel or side label or on a rear panel or rear label. CMA provides this suggested amendment based on previous requirements outlined in TGO 69 and on a risk appropriate basis. To elaborate further on mock up labels provided in 2014, CMA includes specific examples where for listed CMs containing three active ingredients to be displayed on the front of the label, where previously they would be detailed at the side or rear, how this would impact on label size being inappropriate for the packaging. Sec 9 (7) If the medicine is intended to be, or is, registered goods, then: (a) where the medicine contains three or four active ingredients, the name of the active ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on the main label in a text size of not less than 3 millimetres (b) where the medicine contains four or more active ingredients and the requirements of subsection 8(2) do not apply, then the names and the quantities or proportion of the active ingredients may be included on a side panel/label or rear panel/label, when CMA proposed that TGO 69 requirements be maintained. By imposing subsection 9(7)(b) would mean a requirement to go from two or more active ingredients to four or more active ingredients that may be declared on a side panel/label or rear panel/label. This would increase the regulatory cost for registered complementary medicines without any specific evidence of consumer benefit relating to this lower risk class of good being presented. Within the complementary medicine category, listed and registered complementary medicines will be presented (depending on the number of active ingredients present) in a different manner. That is some will detail active ingredients at the front of the pack while others (with 4 or more active ingredients) will detail the ingredients at the side or rear of the pack. CMA submits that for the purposes of standardisation of where to find information, consumers should be encouraged to refer to the back/side of the pack for ingredient information. CMA provides at appendix 1 example 1, a mock up of a registered CM provided to demonstrates how the inclusion of 9 (7)(a) would not work and necessitate labelling complications and medicine container size considerations. See comments at Sec 9 (7)(a) above. CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 4 of 12

5 Proposed Requirement TGO 92 displayed in a text size of not less than 2.5mm. Sec 10(3) & Sec 10 (4)(a) Homeopathic medicines Where all the active ingredients in a medicine are homoeopathic preparations, the main label on the container and the main label on the primary pack (if any) must, in addition to the requirements referred to in sections 8 and 9 above, include a statement to the effect that the medicine is a homoeopathic medicine 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 2millimeters CMA does not support any additional change to this lower risk category of medicine. No explanation or justification has been provided as to why there is a new mandatory requirement to include a statement on the main label that the medicine is a homeopathic medicine or contains homeopathic preparations in an increased font size to that of a general listed complementary medicine. No real explanation has been provided as to why an increase to the font size for the statement homeopathic medicine was considered a requirement based on a consumer safety perspective. Previous explanations for this addition has centred around that the statement is intended to assist consumers with an appropriate selection for a medicine and minimise confusion that may arise with self-selection. However, the current labelling Order requires there to be a declaration that clearly states the product is homeopathic and contains homeopathic ingredients on the front of the pack and the additional detail of this information on the back of the pack in the ingredients and indications section would clearly justify the medicine as being based in the homoeopathic paradigm. As such CMA proposes that this section be removed from the Order. Sec 6 Interpretation in this Order Homoeopathic medicines naming conventions CMA submitted in May 2013 via the International Harmonisation of Ingredient Names consultation that there appeared to be no mention of the naming of homoeopathic ingredients. That is the use of Homoeopathic Pharmacopoeia (HPUS)/ traditional naming or the application of new/ AAN homoeopathic names. As such we resubmit information for consideration here. CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 5 of 12

6 (line 305) Name of the active ingredient (b) where the ingredient is a homoeopathic preparation: (i) either the name of the active ingredient, or the substance from which the dilution was prepared, that is accepted for inclusion in the Australian Approved Names (AAN) List, together with a statement of the homeopathic potency; or (ii) until such time as a name is accepted for inclusion in the Australian Approved Names List, a traditional homoeopathic name in full or as traditionally abbreviated with a statement of homeopathic potency It is suggested that an amendment be made to allow for homeopathic medicines: The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets; 1. The traditional homeopathic pharmacopeia name as the primary name with the Australian Approved Name (AAN) in brackets; together with a statement of the homeopathic potency a. E.g. Sinapis nigra (Brassica nigra) 6X 2. For small containers, the traditional homeopathic pharmacopeia name only; together with the a statement of the homeopathic potency a. E.g Sinapis nigra 6X To implement this, CMA proposes the following amendment to the definition of the name of the active ingredient: (b) where the ingredient is a homoeopathic preparation: 1. the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency; in brackets, the name that is also accepted for inclusion in the Australian Approved Names List 2. for small containers, the name of the active ingredient expressed as the traditional homoeopathic name (in full or as traditionally abbreviated) with a statement of homoeopathic potency. That is, the traditional homeopathic name to be used as the primary name including the AAN unless on small containers. Both the traditional names and AAN could be included on full website information, which would allow additional space to elaborate on the naming of traditional homeopathic ingredients (where required). It is in the consumers interest that traditional pharmacopeial names be amended as the primary name. The concern here is CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 6 of 12

7 that by enforcing the current definition and taking the AAN name alone, outside of the traditional context, the consumer may only get the name in its full chemical/non homeopathic form causing potential confusion and or safety concerns. Additionally, the AAN name alone (due to small label space requirements) may appear as a different active ingredient all together causing consumer alarm. To elaborate, examples have been appended and provided with this submission. Small containers Sec 10 (7)(d) following information to be displayed in a text sixe of not less than 2mm; the names of all active ingredient(s) in the medicine, unless there are four or more active ingredients Sec 10 (d)(e) Following text size of not less than 1.5mm -where four or more active ingredients, the names of the active ingredients Medicine Kits The label on the package that, together with medicines, constitutes a medicine kit must include the following information: (a) The name given to the kit; and (b) The name and contact details of Amended to accommodate where four or more ingredients Amended to accommodate where four or more ingredients This section of the Order appears to have been amended to remove the requirement for statements of purpose for each medicine within the kit, which CMA supports. CMA stated - Based on the requirement in subsection 12(f), complementary medicine kits would be Required to state the functionality of each of the medicines within a kit. Being multi ingredient based with ingredients that often overlap in their therapeutic approach, it would be very repetitive to list the functionality of each medicine and take up considerable space on the label. CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 7 of 12

8 the sponsor of the kit; and (c) The name of each of the medicines within the kit and its dosage form; and (d)the name and quantity or proportion, of all the active ingredients in each of the medicines within the kit; and Very small containers Removed from TGO 92. These requirements were drafted with regard to medicines such as vaccines, they are not required in the draft TGO 92 Sec 11 (1)(b) The abbreviations to 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 abbreviation μg may be used. Agree with removal Where several ingredients are presented on a label statement in microgram, microliter quantities, the repetition of expressing the unit in full greatly expands the length of the text. This proposed requirement, if mandatory does not allow for consistency on the label and increase label space required. An abbreviated form of microgram should be permitted. CMA questions if the requirement is mandatory, given it is expressed as should in the standard compared to must in the guideline. Expression of herbal active ingredients Sec 11 (2) Expression of quantity or proportion of active ingredients This amendment appears to propose that herbal ingredients include the actual amount of herbal extract in addition to the equivalent amount of starting herbal material from which the preparation was derived. The 2014 consultation suggested the reasoning that it 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. CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 8 of 12

9 11(2)(i) states that in addition to the requirements of paragraphs 11(2)(a)- 11(2)(h), and therefore includes 11(2)(a) the quantity of the active ingredient. 11(i)(ii) where the active ingredient is a herbal preparation as the dry or fresh weight of the herbal material from which the preparation was derived except To implement this it would require at least two lines for each herbal material ingredient on the medicine label, to express both quantities. If implemented CMA considers that this requirement would significantly increase the regulatory burden of lower risk listed medicines by increasing the amount of information required on a label and hence label size. CMA stresses that the addition of this extra information, for the average consumer, would most likely create confusion as to which line of expression to draw a meaningful conclusion from. Additionally, the detail of the herbal extract can already be obtained from the public ARTG records so the consumer already has access to this information if they wished to specifically seek out such information. Transitional arrangements Transitional arrangement of 31 December 2019 where compliance with TGO 69 or 92 apply 1 January 2020 TGO 92 applies Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label Gluten or ingredient derived from gluten containing grain. Circumstance where gluten is present in a concentration of 20 parts per million or more. CMA supports that additional time has been provided for implementation of the final Labelling Order. We do however highlight that even with these timeframes there will still be a burden placed upon any small owneroperator complementary medicine business that would not generally be in the practice of changing their medicine labels every few years (as indicated in the 2014 CMA response - RIS document). Accepted CMA recommendation. CMA TGO 79 submission highlighted that the two provisions for the declaration of gluten on the label from an ARTG generated label statement and TGO 79 appeared contradictory. TGO 79 required declaration Contains gluten where gluten or an ingredient derived from gluten-containing grain is present. (No provision for gluten being below certain ppm) TGO 92 a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more. This is to align with Food Standards Australia New Zealand. CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 9 of 12

10 Schedule 1 -Substances or groups of substances present in medicines that are required to be declared on a medicine label All gelatine capsules contain sulphite. CMA quires if a circumstance could be added to this section that aligns the level to the Food Standards Australia New Zealand, that is a circumstance where sulphite is present at quantities grater than or equal to 10part per million (10ppm). Sulphite declaration Schedule 2 Specified units for Enzymes CMA recommends the addition of Bromelain to Schedule 2 Unit Unit description Permitted ingredients PU Papain Units Bromelain Specific comment in relation to the guideline for medicine labels, draft version 1.0, October 2015 Proposed Requirement the guideline for medicine labels Where standardisation of a herbal material or preparation is claimed. In the given example of Camellia sinensis leaf standardised to cetechins, CMA propose the removal (of Camellia sinensis) after the standardised component name. [standardised to contain cetechins (of Camellia sinensis) 30mg] This is proposed as all the information of the herbal active ingredient (weight of preparation and herbal material, and CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 10 of 12

11 Proposed Requirement the guideline for medicine labels quantity of standardised constituent) would be expressed together. This reiteration appears to be redundant and would take up more space on the label. Schedule 1: Schedule 1: Phenylalanine Some inconsistencies in the declaration statement of certain substances in Schedule 1 of TGO 92 compared to warning statements generated on the ARTG. Contains alcohol vs contains ethanol (%v/v) Contains sorbates vs contains [insert name of sorbate] (if the medicine contains one sorbate)or contains sorbates (if the medicine contains two or more sorbates) in the event that the medicine contains only potassium sorbate, according to the warning statement required on the ARTG, the label would have Contains potassium sorbate, whilst it would read Contains sorbates to comply with schedule 1 of TG0 92. CMA proposes that the schedule 1 list include additional information as to what ingredients the phenylalanine warning applies to. It is proposed that ingredients to which the declaration of phenylalanine is required be included, or to provide exemptions where the declaration is not required, e.g. mineral amino acid chelates, spirulina where phenylalanine is naturally present as part of the amino acid profile. Imposing such requirements to all ingredients may cause unnecessary concern to the consumer. CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 11 of 12

12 Proposed Requirement the guideline for medicine labels Previous TGO 79 guidance Order of information Previous TGO 79 guidance Order of information Detailed information within the panel must be presented under the specified headings in the following order [section 10(20)(e)]: Ingredients Uses or What this medicine is used for Warnings Directions for use Other information. CMA understands that a MIP is not required for listed medicines, however, it is not clear from the revised order or the guidance whether the later requirement (presented in a specified order) needs to be followed for listed medicines CMA interprets the revised TGO 92 update to mean that this would no longer be a requirement. CMA response to TGO 92- Standards for the labels of non-prescription medicines Page 12 of 12