Revised: 24 January 2024
About Medsafe
What's New
List of latest updated/new Datasheets and CMI can be found here
Additions to the Medsafe Website - 1 - 31 January 2024
24 January 2023
Information for Consumers
Consumer Information Leaflets
Epilepsy medicines and pregnancy (Te Reo version) (PDF 569
KB, 2 pages)
Safety
Dear Healthcare Professional Letters
Paxlovid (PDF, 7 pages, 630KB)
17 January 2024
Publications
Media
Medsafe successfully prosecutes seller of fake “Miracle Cure"
Additions to the Medsafe Website - Week to 31 December 2023
29 December 2023
Information for Consumers
Consumer Information Leaflets
New labelling requirements for excipients (PDF, 157 KB, 2 pages)
Additions to the Medsafe Website - Week to 17 December 2023
13 December 2023
Medicines
Approval Process
Forms and Templates
Declaration to accompany a data sheet (December 2023) (Microsoft
Word document 39KB)
Information for Industry
Current Guidelines on the Regulation of Therapeutic Products
in New Zealand
Manufacture of medicines (PDF 651 KB, 22 pages)
COVID-19
Vaccine Approval
Status of NZ Vaccine
Applications
12 December 2023
Medicines
Approval Process
Forms and Templates
Changed Medicine
Notification Form B (use from 1 February 2024)
(Microsoft Word, 24 pages 82KB)
Information for Industry
Regulatory Consultants
Information for Consumers
Consumer Information Leaflets
Epilepsy medicines and pregnancy
(PDF 271 KB, 2 pages)
Additions to the Medsafe Website - Week to 10 December 2023
8 December 2023
Medicines Classification Committee
Agenda
Update - Comments for 71st Meeting
Medicines Classification Committee
Dates and Deadlines
Additions to the Medsafe Website - Week to 3 December 2023
29 November 2023
Medicines
Approval Process
Forms and Templates
Changed Medicine Notification Form
B (use from 1 February 2024) (Microsoft Word, 24 pages 84KB)
Committees
Medicines Adverse Reactions Committee
Agenda for the 196th
Medicines Adverse Reactions Committee Meeting - 7 December 2023
28 November 2023
CommmitteesMedicines Classification Committee
Update - Reclassification of methenamine hippurate
Additions to the Medsafe Website - Week to 26 November 2023
21 November 2023
Medicines Approval Process
Approval Process Forms and Templates
Data sheet template explanatory guide (v1.2, PDF 448 KB, 26 pages)
Data sheet template (v1.3, Word 35KB, 2 pages)
Safety
Safety Communications
Update - Interleukin inhibitors and the possible risk of pancreatitis
Safety Information
How Does Medsafe Monitor Medicine Safety?
How Does
Medsafe Monitor Vaccine Safety?
Safety Reporting
Adverse
Reactions to Medicines and Vaccines