Information for Industry

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

Approval Process

Date	Type	Title
21/04/2021	COVID-19	Adverse events following immunisation with COVID-19 vaccines: Safety Report #3 – 20 March 2021
14/04/2021	COVID-19	Adverse events following immunisation with COVID-19 vaccines: Safety Report #2 – 13 March 2021
12/04/2021	Consultation	Outcome of the consultation on the Plan to update the New Zealand Code of Good Manufacturing Practice PIC/S Guide PE009-8 to PE009-14
9/04/2021	Committees	Agenda for the 110th meeting of the Medicines Assessment Advisory Committee - 13 April 2021
7/04/2021	Monitoring Communication	Update - Possible risk of psoriasis exacerbation with bupropion
7/04/2021	COVID-19	Adverse events following immunisation with COVID-19 vaccines: Safety Report #1 – 6 March 2021
29/03/2021	Consultation	Outcome of the consultation on the proposed changes to paracetamol warning and advisory statements
23/03/2021	Alert Communication	UPDATE: Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
16/03/2021	Alert Communication	UPDATE - Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy
4/03/2021	Committees	Agenda for the 66^th meeting of the Medicines Classification Committee
22/02/2021	Consultation	Consultation on Plan to update the New Zealand Code of Good Manufacturing Practice

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