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

We note that the proposed implementation date of 1 September 2020 has been chosen to align with the implementation date for similar labelling changes proposed by the TGA in Australia.
Therefore, this implementation date is achievable for all Australia-New Zealand share packs.

For New Zealand packs and export/international share packs we do not agree with the date of 1 September 2020. We do not believe sponsors will be able to meet this date. We do not believe this transition period is practical considering lead times for activities such as artwork preparation, regulatory submission approval and manufacture. We request that you engage further with sponsors to agree on an appropriate implementation timeframe.

We seek clarification on one aspect of this consultation which applies to all of the substances. We notice some contradiction between this proposal and the general requirement of the labelling statements database.

The labelling statements database states that it:
"lists the warning and advisory statements that are required on medicine and related product labels under regulations 13(1)(i) and 14(1)(f) of the Medicines Regulations 1984. Words of a similar meaning to the statements in the database may be used and individual statements may be combined provided the intent is not changed."

This consultation does not make any mention that words of a similar meaning can be used. It only proposes statements e.g. "Caution: contains galactose". It is unclear whether this exact statement is to be required, or if words of a similar meaning can be used as per other statements in the labelling statements database, or if it would be acceptable to not include ‘Caution’ on the pack . We recommend that some flexibility is provided considering Australia/International share packs supplied to NZ. If specific wording of statements are required, it will make them more difficult to implement.

For instance, the TGA does not require "Caution:" to be used. Their warning statement for the same substance is "contains galactose. It would be preferable to remove ‘Caution’ from the proposed warning and advisory labelling statements to avoid any confusion by sponsors in their interpretation of “… words of a similar meaning can be used…"

Lastly, we kindly ask that for all future consultations conducted through Ministry of Health's online Consultation Hub, a downloadable and printable version of the consultation document and questions is made available.
We suggested this when the Consultation Hub was first trialed in October 2018 for a consultation regarding clinical trial guidelines. We were pleased when a separate consultation document with the list of consultation questions was provided for the Therapeutic Products Bill consultation. Providing a separate document is incredibly useful as it aids submitters with reviewing the contents of consultations, planning responses and sharing draft responses with colleagues. For organisations this is particularly important as responses often need input from several departments and require several levels of internal review.
We recommend that this becomes a requirement for all consultations across all Ministry of Health departments.