Published: 2 March 2017

Data Sheets are Changing!

Prescriber Update 38(1): 2
March 2017

In March 2016, Medsafe held a consultation on the format of the data sheets. As a result of this consultation, Medsafe has now confirmed that the data sheets should follow the European Summary of Product Characteristics (SmPC) format. This means that the information will be ordered in the same sequence in all data sheets with the clinical information near the beginning. In addition, there will be a summary table at the end of each data sheet outlining the changes from the previous version.

The change-over has already started. Companies have until 28 February 2019 to reformat their existing data sheets.

Find out more on the Medsafe website (

Data sheets are available on the Medsafe website (