Revised: 27 June 2013

Consultations

Update to Section 13.2.2 Preparing a Data Sheet for Approval - Content
NZRGM, Volume 1, 5th edition]

6 November 2007

Medsafe wishes to confirm the following information.

The nomenclature system (eg INN, BAN etc) used to identify the drug substance(s), (active ingredient(s)), in the product data sheet should be consistent with the nomenclature system used to identify the drug substance(s) on the drug product labelling.

 

Guidance on the publication of datasheets can be found here www.medsafe.govt.nz/regulatory/guidelines.asp#Part10