Proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions

"Contains residual [antibiotic name]"
TGO92 (Australian labelling) does not require the use of the word "Caution". For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warnings" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling. In addition, although the proposed statement implies that it is acceptable to use the term "alcohol" it would be useful for Medsafe to clarify this.

The TGO 92 requirements for disclosure of fish products on Australian non-prescription medicine labels includes cod, cod liver oil, halibut, and tuna - however this is accompanied by a note stating that the fish statement includes freshwater fish, diadromous fish and marine fish, including shark. The Australian TGO 92 statement is a more inclusive statement. CHP Australia recommends alignment of the Medsafe and TGO 92 statements.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

TGO92 (Australian labelling) does not require the use of the word "Caution"; For registered medicines in Australia, typically this information is included under a sub-heading titled "Warning" and the requirement to include "Caution" as part of the statement results in non-alignment with Australian requirements and the need for unique NZ labelling.

The statements proposed by Medsafe (that feature the word "Caution") do not align with TGO 92 and therefore this means that the transition period of 1st September 2020 is impractical for ALL products.
Should Medsafe decide to align with TGO 92 compliant labels, then this date may be achievable for some products with harmonised labelling but is not achievable for New Zealand only products. A timeframe of one year is insufficient for design of new labels, preparation of regulatory submissions and regulatory approvals for labelling, and does not take into account the sell-through of products in existing labelling. These requirements should not require write offs of products and product components, such as packaging and labelling, which will force industry to incur a significant cost of compliance.
The TGA had a 4 year transition period for TGO 92. This update to the NZSLDB will affect nearly every label and multiple pack sizes and sponsors will incur significant costs for the update, including Medsafe application costs.
CHP Australia believes that a similar transition period to TGA (4 years) is essential to plan and implement these changes in New Zealand, as sponsors will need to plan which of their many sponsored products to update first, depending on volumes, location of manufacturing sites, how many batches are marketed and seasonality.
In a practical sense, products in harmonised labelling will be able to achieve compliance well within a 4 year timeframe but it is necessary for transition to be practical and achievable for all products and it makes business sense to be able to spread the cost of compliance over a longer timeframe. Note also that sponsors will have finalised their 2019-2020 budgets already and will not have included the significant cost of compliance in their budgets for this year.

-Please also refer to our email, sent to Redacted text.
-Medsafe and the TGA should have processes in place to ensure that the NZLSDB is updated whenever TGO 92 is updated. The two regulators should have regular communication to ensure that there is alignment between the TGA and Medsafe labelling requirements.
-Medsafe should be clear about whether the word "caution" is needed for each statement, as this will means that Australian and New Zealand labels cannot be harmonised. Medsafe should accept the Australian requirement for "contains [ingredient]. For Australian registered medicines, this information will be included under a sub-heading of "Warnings" within the Consumer Health Information (CHI) panel.
-Are "words to the effect of" or additional statements allowed (e.g. "contains hydroxybenzoates (preservatives)"
-Grouping of statements (e.g. "Contains ingredient A, ingredient B, ingredient C) should be allowed
-Clarification of the transition date is needed. To minimise write-offs and disruption to business it should apply to the release for supply step as per TGA's interpretation .