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Medsafe - Proposed regulatory changes to medicine data sheet format

Medsafe is consulting on a proposal to standardise the data sheet process and the Guideline on the Regulation of Therapeutic Products in New Zealand. Part 10: Requirements for information for prescribers and consumers Currently New Zealand data sheets place clinical trial and pharmacology data before prescribing information, such as the approved indications, contraindications, warnings and precautions. Medsafe proposes a change to require a standard format for data sheets based on the European Summary of Product Characteristics (SPC) format, with minor adaptations to meet certain New Zealand legislative requirements and current regulatory policy. To this end, Medsafe proposes a timeline of 1 January 2017 for the format and layout changes to be implemented for all approved data sheets.

In addition, Medsafe is also seeking comments on the use of preferred terminology, electronic information delivery methods and the desirability of introducing "data sheets" for higher-risk medical devices, in order to inform the proposed new Therapeutic Products legislation.

The consultation documents can be found at

Feedback Due: Please send feedback to by 21st March 2016.