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

Overview

This Medsafe consultation proposes labelling requirements for substances/groups of substances in medicines and related products that may cause an undesirable reaction (eg, allergies) in some people. 

Unlike foods, most medicines and related products are not required to list all the ingredients that are included in the medicine on the label. The active ingredient will always be on the medicine label, but only some inactive ingredients, also called excipients, must be on the label. Also, some potential allergens, such as impurities from manufacturing, may not be on the label.

We will implement these new labelling requirements through the Label Statements Database. This database lists the warning and advisory statements that are required on medicine and related product labels under the Medicines Regulations 1984. 

We are seeking your views on having warning statements for the substances/groups of substances listed below. 

Substances to be included in the Label Statements Database

*      Ethanol and tartrazine are already included in the Label Statements Database, but we are proposing changes to the conditions and/or statements.

What happens next

All comments will be considered. Once the analysis of submissions is complete, the Label Statements Database may be updated to include some or all of the new statements.

We will publish the outcome on the Outcome of Consultations web page on the Medsafe website.

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