Medicines

Policy Statements

Date	Policy
3 May 2025	Early notification of potential medicine supply issues
12 March 2025	Clinical trials – Protocol clarification letters
29 August 2023	COVID-19 vaccine strain update application procedure
23 September 2022	Medsafe policy for nitrosamine impurities in medicines – information for sponsors
11 June 2018	What to do in the case of a potential out of stock
21 June 2017	Change to Label Statement Database for OTC loratadine and desloratadine medicines
18 April 2017	Tips for changing to the new data sheet format
19 October 2016	Reminder to sponsors: Timeframes for provisional consent
20 July 2015	Changes to Priority Assessment Process
28 May 2014	Changes to the Definition of Medicines and Medical Devices Effective 1 July 2014
2 May 2014	Biosimilars
10 July 2013	Subdividing of Tablets
6 May 2013	Proprietary Ingredients
1 February 2013	Update to Therapeutic Product Database Reports
February 2013	Changing Registration Situation
January 2012	Acceptability of Claims for Pain Relief
1 March 2010	Priority and Abbreviated Assessments