Information for Industry

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

Approval Process

Date	Type	Title
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
29/09/2020	Monitoring Communication	Possible risk of psoriasis exacerbation with bupropion
23/09/2020	Consultation	Outcome of the consultation on the proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions
16/09/2020	Alert Communication	Medsafe is issuing a warning that Elevacity Elevate Smart Coffee (Version 3) should not be consumed - statement under section 98 of the Medicines Act 1981
15/09/2020	Media Release	Medsafe takes action to prevent the supply of illegally marketed medicine linked to liver harm
11/09/2020	Committees	Medicines Classification Committee - Dates and Deadlines
11/09/2020	Media Release	Medsafe has completed its review of Objections from the 64th Medicines Classification Committee to reclassify pholcodine
3/09/2020	Publications	Prescriber Update 41(3) - September 2020

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