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

Closed 8 Aug 2019

Opened 27 Jun 2019

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 DatabaseThis 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

Antibiotics Lactose Sodium salts
Aspartame Milk and milk products Sorbic acid and sorbic acid salts
Benzoates Peanuts and peanut products Soya beans and soya bean products
Crustacea and crustacean products Phenylalanine Sucralose
Egg, egg products Pollen Sugar alcohols
Ethanol* Potassium salts Sugars
Fish and products Propolis Sulfites
Galactose Royal jelly Tartrazine*
Gluten Saccharin Tree nuts and tree nut products
Hydroxybenzoic acid esters Sesame and sesame seed products  

*      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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Audiences

  • Members of the public
  • Health sector
  • Ministry staff
  • Pharmaceutical companies

Interests

  • Therapeutic products