Published: 16 December 2013

Consultations

Changes to the Label Statements Database for aspirin

To:
Product sponsors
Applicants for new and changed medicines
Regulatory affairs consultants

This letter is to:

• signal changes to the labelling requirements for aspirin
• provide a contact point for queries or feedback on the proposed changes.

Background

Under the current Label Statements Database, sponsors of aspirin products can choose between the following warning statements:

• do not use in children under 12 years of age except on doctor's advice.
  
  Or
  
• unless a doctor has told you to, do not use this product in children under 12 years of age or teenagers with chickenpox, influenza or fever.

To harmonise with Australia, Medsafe proposes that the Label Statement Database should be amended to just the latter option:

• unless a doctor has told you to, do not use this product in children under 12 years of age or teenagers with chickenpox, influenza or fever.

Next steps

The target implementation date for the changes described above is 3 March 2014.

Queries about, or comments on, the proposed changes described above should be sent to:
Laurence Holding
Medsafe
PO Box 5013
WELLINGTON

Email: askmedsafe@health.govt.nz

by Monday 3 March 2014.

Comment on the feedback received and any resulting adjustments to the new requirements will be provided through the Medsafe website (www.medsafe.govt.nz).

Yours sincerely,
Sarah Reader
Manager Product Regulation