Published: 23 September 2020
Revised: 30 October 2020

Consultations

Outcome of the consultation on the proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions

Summary
About the consultation
Submissions received
Outcome
Implementation date
Enquiries

Summary

About the consultation

This Medsafe consultation proposed new warning statements for the labels of medicines and related products that contain substances/groups of substances that may cause an undesirable reaction (eg, allergies) in some people.

The new statements align with those required on medicine labels in Australia, under Therapeutic Goods Orders (TGO) 91 and 92. Many medicines marketed in New Zealand are also marketed in Australia and have harmonised labels (ie, are distributed in the same pack in Australia and New Zealand).

The consultation opened on 27 June 2019 and closed on 8 August 2019.

More information about the consultation.

Submissions received

There were 260 responses to the consultation. Respondents included members of the public, health care professionals, industry, and government and consumer organisations. Most respondents were supportive of the labelling changes.

You can view the submissions that we have permission to publish.

Medsafe would like to thank all those who took the time to respond to the consultation and provide comments.

Outcome

The information below is only a brief summary of the consultation outcomes. For the full consultation feedback and Medsafe’s response, please download the Consultation outcome document.

Based on respondent feedback, we have made some minor changes to the proposed statements – see the Warning statement results section of the Consultation outcomes document for details.

Key changes are as follows.

  • We received feedback that the examples in the Medicine/Group/Class column (called ‘inclusions’ in the consultation) were too specific. These are examples only and should not be considered a complete list. Therefore, we have modified the text in the Medicine/Group/Class column to say ‘Examples include:’
  • We have removed the word ‘caution’ from the statements to align with the Australian statements.
  • For the gluten statement, the source of the gluten should be identified, the statement should apply to all uses, and the threshold has been lowered from the proposed 20 parts per million (ppm) to 3 ppm.

Implementation date

The proposed implementation date for the new warning statements was 1 September 2020. However, based on feedback from industry, the implementation date has been revised to:

  • 1 March 2021 for New Medicine Applications
  • 1 March 2024 for existing products.

Medicines released for supply in New Zealand after 1 March 2024 must have updated package labels. However, Medsafe encourages sponsors to update their labels before this date if feasible.

The Label Statements Database was updated on 30 October 2020 to include the new warning statements.

Enquiries

Any questions relating to this consultation should emailed to: medsafeapplications@health.govt.nz

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