New Zealand Regulatory Update

New Zealand Consultation on Proposed Warning Statements for Allergens in Medicines

BY Angela McGillivary, Principal Consultant, Parexel Consulting - 8.7.19 -

Medsafe opened a public consultation on 27th June, they are proposing that manufacturers of medicines and related products include substances that may cause an allergic reaction on their label.

Reason for Consultation?

Until now it has only been a requirement for manufacturers of food products to list all ingredients on their label. Medicines are only required to include the active ingredient, and some excipients, impurities from the manufacturing process are not required to be included although there is potential that they may cause an allergic reaction.

Medsafe is taking this step to ensure the safety of medicines and to also bring their labelling requirements in line with Australia.

What does this mean for Industry?

The impact to industry is that if any of the 29 substances listed in the table below are contained in a medicinal or related product, they will have to be disclosed on the product label/ packing from 1st September 2020.

Two substances, ethanol and tartrazine are already included in the label statement database however Medsafe are proposing changes to the conditions and statements to align with the Australian labelling requirements.

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

Medsafe is seeking industry consultation from members of the public, healthcare professionals, consumer groups and industry on the proposal.

Comments can be made via their online consultation website, the survey presents the list of allergens with the Medicine/Group/Class, conditions, statement and implementation date. Industry is asked if they agree with the conditions and the statement and implementation date.

Antibiotic example given below:

Medicine/Group/Class Conditions Statement Required By

Antibiotics

For all classifications, including prescription, and all uses - when the antibiotic is not an active ingredient and is present only as a residual impurity.

Caution: contains residual [antibiotic name]

1/09/2020

1.      Should labels include a warning statement for antibiotics?
2.      Do you agree with the proposed conditions for antibiotics?
3.      Do you agree with the proposed statement for antibiotics?

Industry, healthcare professionals, consumer groups and members of the public have until 8th August to provide their comments

https://consult.health.govt.nz/medsafe/labelling/consultation/

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