Information for Industry

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

Approval Process

Date	Type	Title
12/11/2019	Monitoring Communication	Update 7 November 2019 - Breast Implants and anaplastic large cell lymphoma
12/11/2019	Monitoring Communication	Suspected adverse reaction reports to lamotrigine after changing brands
4/11/2019	Consultation	Consultation on proposed changes to current warning and advisory statements for paracetamol
25/10/2019	Committees	Minutes of the 179th Medicines Adverse Reactions Committee Meeting
21/10/2019	Alert Communication	Medicines containing ranitidine and a potential impurity, N-nitrosodimethylamine (NDMA)
21/10/2019	Monitoring Communication	Losartan approved medicines supplied in New Zealand not affected by recalls overseas
21/10/2019	Monitoring Communication	Review of chemically synthesised active pharmaceutical ingredients for presence of nitrosamine impurity
16/10/2019	Committees	Agenda for the 108th meeting of the Medicines Assessment Advisory Committee - 13 November 2019
14/10/2019	Medicines	Part 2: Obtaining approval for new and changed medicines (PDF 1220KB, 65 Pages) and Appendix 8: Data Requirements for New Medicine Applications (PDF 212 KB, 26 pages) have been updated
11/10/2019	Notices	Medsafe Office Closure Christmas/New Year 2019/2020
11/10/2019	Alert Communication	Surgical Mesh Implants - Adverse Event Reporting and Monitoring - Link to the latests October 2019 report
9/10/2019	Publications	Medical Device Adverse Event Reporting
8/10/2019	Notices	Notice of Medsafe Office Closure Christmas/New Year 2019/2020

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