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Consultations

Published: 16 December 2013

Changes to the Label Statements Database for aspirin

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

This letter is to:

Background

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
Medsafe
PO Box 5013
WELLINGTON
 
Email: Laurence_holding@moh.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 

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