appendix 1 tabulated comments on tg092

Appendix 1 - Tabulated comments on TG092

Document(s): Therapeutic Goods Order No.92- Standard for labels of prescription and related medicines (TGO 92)

I consider the proposed TGO 92 acceptable in its present form D I consider the proposed TGO 92 acceptable "as is" but I have proposed minor suggestions for improvement*

*Please refer to my response below D

I do NOT consider the proposed TGO 92 acceptable in its present form, and I have proposed various responses for consideration* IZI *Please refer to my response below

Page Section Issue/Item Suggestion/Response:

5 Transition 4 (2) On and from «1 January 2020- 4(2) Pfizer agrees with compliance to TGO 92 on and from 0 1

tbc» ... medicines must comply with the January 2020. However clarification is required whether this

requirements of this order date refers to the date from release for supply from the

manufacturing site or warehouse i.e. OHL

9 6. Interpretation • Does the statement imply that the Clarification is required on the points discussed under

Name and contact previous sponsor details could Issue/Items.

details appear on the labels for at least 12

(b) Where there has months after the change or for not Pfizer proposes a transition period of 24 months to change

been a change in the longer than 12 months after the the sponsor's /distributor's address from the previous

sponsor's or change? sponsor/distributor to the new sponsor/distributor details.

distributor's name or • What is the time_point which will We suggest a clarification to the wording of this subsection.

contact details in the define the commencement of the 12 Pfizer proposes a transition period of 24 months to change

Consultation submission: Medicine labelling - Pfizer Australia Pty Limited

previous 12 months , the name or contact details of the previous sponsor or distributor

month timeline? • Pfizer is in agreement with the

principle to achieve on going compliance. However, we believe that timeframe allocated in this section to allow sponsors to amend the sponsor’s or distributor’s details on the labelling is not sufficient.

the sponsor’s /distributor’s address from the previous sponsor/distributor to the new sponsor/distributor details.

9 6. Interpretation Name of an active ingredient means: (a) the name of the active ingredient that is accepted for inclusion in the Australian Approved Names List;

TGO 92 refers to the Australian Approved list(AAN) names The AAN list should be amended accordingly to the IHIN list (International harmonization of Ingredients names). Pfizer’s opinion is that the documents AAN, IHIN, and the TGO92 should be issued and implemented concurrently. There are implications of IHIN vs AAN with regards to the length of some ingredient names in addition to increased letter size requirements: E.g. AAN = dextromethorphan hydrobromide vs IHN dextromethorphan hydrobromide monohydrate. The revised AAN list and or the guidance for labelling should consider in particular the expression of the ingredient names on medicine labels for non-prescription products as per common practice as outlined in examples below: 1. Calcium xxmg (as Hydrogen Phosphate), disregarding water of hydration when there are two salts identical with the only difference being the water of hydration; 2. Magnesium xxmg (as Oxide), disregarding whether the


AAN is magnesium oxide light or heavy;

11 6. Interpretation Small containers

Small containers means a container that has a capacity of 25mL or less

From a non-prescription medicines perspective, Pfizer’s proposal is as follows: Replace the concept of small container by the concept of label surface being the cut off limit a label surface of 70cm2

or redefine small containers.

11 6. Stated volume of fill

Volume of the medicine that the container is specified by the sponsor to contain

Need to ensure is not in conflict with Consumer Law with reference to deceptive packaging.

12 7.General Requirements including label presentation

(3) Compliance with advertising requirements, in particular Part 5.1 of the Act/Regs and the applicable provisions of the Therapeutic Goods Advertising Code

Clarification required: the drafting language is confusing and difficult to understand. Is it the intent that everything other than registered or listed medicines must comply with TGAC, or is the opposite the case?

14 8. Information to be included on the label 8 (1) l (ii) there is insufficient space on the label of the container or primary pack to include directions for use and those directions for use are set out in a leaflet inserted in the primary pack of the medicine and a

Pfizer considers that the statement should be rephrased to consider :

• If both primary pack and container labels cannot accommodate the directions for use allow the inclusion of directions for use in a leaflet

• if either of the primary pack or container label can accommodate the directions for use there is no need to include a leaflet.

In both cases the label(s) should indicate where the directions for use are set out.

Pfizer proposes to reword the statement


statement is included on the label of the container or the primary pack, as the case may be, that the directions for use are set out in the enclosed leaflet.

15 8(2) Pfizer concurs with ASMI that this section outlines the information required in the Medicine Information Panel (MIP), while there is no mention of the MIP and no definition of the MIP within TGO92

The definition of the MIP should be included in the Interpretation section of this order

15 & 16 8(2) (b) (i) and 9 (1) (b) Repeating of active ingredients Pfizer believes that the repetition of the ingredients names and quantities in the MIP is not necessary, when the ingredient names and quantities are included on the front panel of the label and there is space constraint.

15 8(2)(f) – “Other information” allows only: A. storage conditions, B. packaging features, C. names of excipients D. sponsor details

Pfizer recognizes ASMI concerns that the MIP sub-heading of “Other information” may not allow additional information such as “sugar free” “gluten free”, cultural/religious (e.g. halal,) etc. Pfizer believes that the section “Other information” is the most suitable place to include this information; however it should also allow the flexibility to include this information in other sections of the labels.

The section “Other information” in the MIP should allow the inclusion of absence of certain ingredients/allergen information.

15 Section 8(3) – If the registered medicine is (i) a medicated throat lozenge, or an inorganic salt-based

Pfizer concurs with ASMI concerns with the limited number of products covered by sections 8 (3) (a) & (b) The space limitations on labels are not specific to throat lozenges, antacids and

The exemption from the requirements in section 8(2) should be allowed for all non-prescription products with primary pack labels less than 70 cm2 and should not be limited to medicated throat lozenges and inorganic salt-based antacids, as other products will have similar difficulties complying.


antacid that is in a

solid dosage; and (ii)

space available for a

label on the primary

pack is less than 70

cm2, or (b) it is

intended for use as a

skin antiseptic by a

HCP as either a hand

hygiene or patient

pre-op prep, then

subsection (2) (MIP)

does not apply

hand-hygiene products used by health care

professionals.

Many other product labels will have

difficulty including the requirements of

section 8(2) (Medicines Information Panel)

when the space available for a label on the

primary pack is less than 70 cm2•

Section 9(2) & (3) Pfizer is concerned that this section could

(9)(2) The name of have significant implications for brand

the medicine must be equity. In many cases global branding

presented in a includes features that will

continuous,

uninterrupted

manner and not be

broken up by

additional

information or

background text.

(9)(3)The name of

the medicine and the

name(s) of the active

ingredient(s)must on

the main label:

(a) (i) appear as a

cohesive

unit ...

separate/interrupt the umbrella brand

name from the rest of the product name.

Pfizer agrees with ASMI proposal to include design matters

in the guidance document than in the order.

Clarification on the intent of this section should be provided.

In the examples listed below (prepared in accordance to the

TGA Consultation Document and included in Appendix 2),

the label designs are part of the branding and include a

graphic interrupting the cohesive unit.

I

16


Not separated by any text or graphics, except…

17 Section 9(5) All text required by this order….direction

Same orientation Pfizer questions the benefit of the requirement to include all the text required by the order in the same orientation. We believe sloping can be used as a tool to facilitate product differentiation. We included in Appendix 2 examples of labels of the product listed below, where sloping is used as a differentiation tool between dosage forms:

•

17 9(7)(a).Information to be included on the main label

9(7)(a) – For registered medicines – where there are three or fewer active ingredients, the name(s) and quantity or proportion must be displayed on the main label in a text size of nlt 3mm

Regarding non- prescription registered medicines labels, Pfizer’s proposal with regards to the active ingredients text size on the main label is as outlined below, which will allow consistency across many pack sizes: For registered medicines – where there are three or fewer active ingredients, the name(s) and quantity or proportion must be displayed on the main label not less than 2 mm except for labels with dimensions of 70 cm2 or less or for small containers. In addition to the above Pfizer proposes an alternative and more broader approach to letter size as described in paragraph below: ‘displayed in a text size of not less than <x> millimetres unless precluded by the available space on an appropriately sized label. In such cases, the largest possible text height should be used’.


17 9(7)(b) - Where

there are 4 or more

active ingredients

and subsection

8(2)(MIP) does not

apply, these may be

included on a side or

rear panel in a text

size of nit 2.Smm

The types of products that are excluded

from the requirement from the Medicines

Information Panel (MIP) under the draft

TGO 92 are:

• medicated throat lozenges and

inorganic salt-based antacids in

presentations with available label

space of 70 cm2 or less

• small containers, • container labels (e.g. labels within

primary packs).

Pfizer is of the same opinion as ASMI with

regards to the space required on the rear

This alternative will reduce the number of section 14

exemptions applications required and the TGA resources

associated with their evaluation and approval.

There are many examples, some included in Appendix 2

where it is not possible to comply with the letter size

requirement without removing other information from the

front panel:

I

I

, does not allow to accommodate

API in a text size of nit 3mm without removing other

information

Pfizer considers this section need clarity on the way is

expressed.

The interpretation of section 9 (7)(b) for this example will be

as follows:

• If the container is included in a primary pack,

subsection 8(2) (MIP) does not apply to the container

label, the letter size requirement for active

ingredients will be 2.Smm. • If the same container is not included in a primary


17

17

9(7)( c) - Where the

medicine contains

four or more active

ingredients, and

subsection 8(2) (MIP)

applies, then

compliance with

9(1)(b) and 9(1)(c) is

not required

9 (7) ( d) Where

subsection 8(2) (MIP)

applies, and there are

one or more active

and side panel to include 4 or more active

ingredients and its strengths in a text size of

2.5 mm will be too large.

There some ambiguities in relation to some

Day and Night cough, cold & flu composite

packs, where the same active ingredient(s)

may be present in both tablets (example -

phenylephrine, paracetamol). It should be

made clear that section 9(7)(c) also applies

to composite packs where four or more

active ingredients must be presented on the

label, even if these may not be completely

different active ingredients for each of the

two tablets/capsules.

Pfizer does not oppose the option of not

including the full names and quantities of

some active ingredients that include in the

names salts or water of hydration in order

pack. in this case it will require an MIP but the letter

size requirements for active ingredients will be

1.Smm-section 7(2) (d).

Pfizer recommends that the requirement for letter size in

the example outlined above should be consistent in both

cases and 9(7)(b) should be amended to read:

"Where there are 4 or more active ingredients these may be

included on a side or rear panel in a text size of nit 1.5 mm"

Pfizer also recommends including the letter size

requirements clearly outlined in every section of the order

and not left to interpretation.

The increased letter size requirements resulted on the active

ingredients printed overlapping the brand's distinctive

feature.

Clarification is needed in the case where there are two or

more actives however, one of the actives includes the salt in

the name:

Phenylephrine Hydrochloride


ingredient names that include descriptors such as hydration states and chemical salts, then the name of the therapeutically active moiety (ies) of the active ingredient may be displayed on the main panel, in a text size nlt 3mm and the quantity or proportion is not displayed.

to free label space, however we also recognize that it could cause confusion among consumers when comparing different product labels.

Guaiphenesin Note: does TGO 92 allow the declaration of both active ingredients on the front panel without the quantity? Letter height should be achievable and consistent with proposal in section 9 (7) (a).

19 10(7) Small containers

10(7) (a) & (b) and (c) & (d) requires name of the medicine and active ingredients in text size nlt 2mm (if there are less than 4 actives). Where there are 4 or more actives, these may be in a text size of nlt 1.5mm

Pfizer agrees with ASMI’s point of view, with regards to non–prescription medicines labels that the labels with a surface area of 70 cm2 or less are those that will have difficulty complying with a 3 mm text size. Therefore the proposal is for the TGA to consider:

• that either the minimum text size required by Section 9(7) (a) is reduced to minimum text size to 2mm overall.

or • the definition of a “small container” should be

amended to those containers with labels of 70 cm2 or less.

demonstrating that compliance with the 3mm text size proposed by the order is


not possible to achieve. or

• consider a broader approach to letter size: displayed in a text size of not less than <x> millimetres unless precluded by the available space on an appropriately sized label. “

20 10(8) Individually wrapped medicines

10(8) (a) and 10(8) (b) – There are different labelling requirements for pastilles and lozenges that are “in an individual wrapper, whether sealed or unsealed”. (10)(8)(a)(ii) and those that are individually wrapped in an unsealed protective cover (10) (8) (b) (iii) – but significantly different requirements.

Clarification required: In both cases 10(8) (a) and 10(8) (b) should be enclosed in primary pack that complies with sections 8 & 9. However the requirements for both are very different. Medicines (e.g. with many actives), should be excluded from the requirements as for these medicines it may not be feasible to comply with 10(8) (a).

22 10 (9)(c ) …can be readily detached, the names of all active ingredients and the quantity…

Medicines with large number of low risk active ingredients, should be excluded from this requirement


Appendix 2 –Examples of Artwork Prepared in accordance to the TGA Consultation Document


Pr

PJo


Appendix 3 - Tabulated comments on Guidance document

I consider the proposed guideline acceptable in its present form D

I consider the guideline acceptable "as is" but I have proposed minor suggestions for improvement* IZ] *Please refer to my response below

D I do NOT consider the guideline acceptable in its present form, and I have proposed various responses for consideration*

*Please refer to my response below

Page no. Section Issue/Item Suggestion/Response:

7 Transition Period Clarification on dates quoted on the order Confirmation /clarification required on the implication of

and guidance document: these dates.

3 1 December2019

1 January 2020 Recommendation is to add clarity to the dates in the order &

October 2017 guidance document

Confirmation /clarification required on the

implication of these dates. Does it means in

practical terms that until October 2017 , the

labels attached to a submission can comply

with either TG069 or 92 and from that date

only labels compliant with TG092 will be

accepted?

From January 2020, any label ex warehouse

should comply with TG092

8 Structure of this Legal mandatory requirements Clarification on legal non mandatory requirements

guidance


8 1.Using the labelling order

Consumers need additional information for self -selection of non-prescription Medicines

S3 are not self-selection, why do they need the same level of information as the self-selection labels and not comparative level of information as the prescription medicines

10 1.4.1 Text size If your medicine is in a small container (with a capacity of 25mL or less) you must display the name and amount of active ingredients and also the name of the medicine in the container in a text size of not less than 2.0mm.

This is still an issue for medicines with multiple APIs i.e. MV or similarly registered complementary medicines to be able to include the name of active ingredients and also the name of the medicine in the container in a text size of not less than 2.0mm

12 1.5.1 Requirement is specified in reg 15 of Therapeutic Good Regulation 1990

Pfizer suggests the addition of a note in the guidance document to clarify that orientation requirement does not apply to the AUST R /L number and letter height as per reg 15 of Therapeutic Good Regulation 1990 is NLT 1mm

13 1.5.5 Medicine Information panel requirements

…An MIP is not required for certain lower risk medicines _these are detailed in subsection 8(2) of TGO92

Should say: …An MIP is not required for certain lower risk medicines _these are detailed in subsection 8(3) of TGO92

14 1.6 Information on the Main label

• Ensure that the use of trademarks graphic or additional text do not disrupt the medicine name

Appendix 2) 14 1.6 Information on

the Main label • Orient all parts of the medicine name

in the same direction The order refers to all text in the main label should be in the same direction while the guideline refers to the medicine name

16 2.1.2 Colour differentiation

• Use fonts of similar size and style for all words of the medicine name

In many examples the brand name may have global connotations and it may have a global alignment, however the font and style in the other parts of the name may help to differentiate a range, for example adult range from a children range …


18 & 35 2.1.8 & 3.1.1 Only the name of the medicine must be repeated every 2 dosage units if your medicine is • A listed medicine that contains 2 or

more active ingredients • A registered medicine that contains

four or more active ingredients

Requirements when the dosage unit can be readily de attached… are clear from page 35 of the guidance document however TGO92, which is the legislative instrument, does not consider the different requirements for listed medicines containing multiple actives i.e. multivitamin/minerals or registered medicines containing more than four active ingredients.

21 2.3.1 Title TGO 92 does not mandate a particular title while the guidelines recommend the use of the title “Medicine Information”

Enforceability of guidelines

24 2.3.1.12 Directions for use

Lengthy directions Refer to comments on page 14 section 8 (1) l (ii) of the order.

31 2.3.3 different ways to name an Active ingredient

Clarification needed • for combination product with more than one active (label including an MIP), however only one of the actives has a long name i.e. Phenylephrine hydrochloride, guaphenesin. Note: please see comments on page 17 section 9 (7) (d) of the TGO92

• Acceptance of the abbreviated expression of active

ingredients i.e.: Magnesium (as oxide) xxmg instead of Magnesium (as Magnesium Oxide) xxmg. This is clear in the section of the guidance 2.4 Information for prescription medicines, however not clear for listed or registered OTCs medicines.


Appendix 4 –Comments on Potential Regulatory Impact POTENTIAL REGULATORY IMPACT 1. Do the proposed amendments to the Therapeutic Goods Orders change any comments that you made in the 2014 consultation with respect

to costings?

Yes No N/A other please specify

Please provide any further comments you wish to make in the box below: Pfizer believes that the amendments to the TGO make the process more achievable in many aspects, specifically with regards to the transition time. Overall, Pfizer supports efforts to make a medicines label clear and easy to understand; however as has been indicated in our submission, we believe that there are still some deficiencies that should be addressed before such an order is implemented. The costing to the business will be essentially similar as estimated in the 2014 comments; however the longer transition time will make the financial burden more manageable.


appendix 1 tabulated comments on tg092

Documents