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

Commmittees
Medicines 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

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