Information for Industry

Guidance on the regulatory processes for suppliers in New Zealand of medicines and medical devices.

Approval Process

Date	Type	Title
19/11/2020	Committees	Agenda for the 184th Medicines Adverse Reactions Committee meeting - 3 December 2020
18/11/2020	Committees	Medicines Classification Committee - Dates and Deadlines
6/11/2020	Notices	Medsafe Performance Statistics for 2018 - July 2020
6/11/2020	Alert Communication	Update to Original Communication - Important updates to clozapine data sheets and monitoring during covid-19 pandemic
5/11/2020	Notices	Codeine-containing medicines have now been reclassified The recommendations from the 59th MCC meeting has been gazetted today
3/11/2020	Notices	Notice of Medsafe Office Closure Christmas/New Year 2020/2021
30/10/2020	Monitoring Communication	UPDATE: Concern reported with the use of NovoRapid® Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
23/10/2020	Committees	Comments on agenda for 65th Medicines Classificaton Committee meeting
23/10/2020	Monitoring Communication	Concern reported with the use of NovoRapid® Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
22/10/2020	Media Release	Codeine-containing medicines to be reclassified
14/10/2020	Committees	Agenda for the 65th Medicines Classification Committee meeting Please note there have been some changes to the agenda relating to removing New Chemical Entities that were classified at the 64th meeting of the MCC and clarification of the agenda item Harmonisation of the NZ and Australian schedules for noting

If you have a query that is not answered by the information in this section please contact us at askmedsafe@health.govt.nz