Published: 16 December 2013

Changes to the Label Statements Database for aspirin

Product sponsors
Applicants for new and changed medicines
Regulatory affairs consultants

This letter is to:


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

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

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
PO Box 5013

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 (
Yours sincerely
Sarah Reader
Manager Product Regulation