Published: 16 December 2013
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:
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:
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 (www.medsafe.govt.nz).
Manager Product Regulation