Revised: 30 June 2025

Information for Industry

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

Approval Process

Medicine Information

Regulatory Guidance

Clinical Trials

Manufacturing

Medical Device Regulatory Guidance

Industry News

Date Type Title
7/1/2026NoticesNotice of Medsafe Office Closure Christmas/New Year 2025/2026
15/12/2025Monitoring CommunicationM² Logo Atomoxetine and the possible risk of gynaecomastia
15/12/2025Alert CommunicationAmended legislation about medicines that can impair driving
8/12/2025ConsultationOutcome on Proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Bioequivalence of medicines
8/12/2025ComplianceExemption for advertising unapproved medicines at medical conferences
4/12/2025PublicationsPrescriber Update Vol. 46. No. 4 - December 2025
3/12/2025Monitoring CommunicationFurther Update - Estradot (estradiol) transdermal patches: reports of quality and efficacy concerns
28/11/2025Alert CommunicationRecall of FreeStyle Libre 3 Plus CGM sensors (some batches only)
11/11/2025Monitoring CommunicationFurther Update - Estradot (estradiol) transdermal patches: reports of quality and efficacy concerns
5/11/2025Monitoring CommunicationUpdate - Estradot (estradiol) transdermal patches: reports of quality and efficacy concerns
3/11/2025Media Release#MedSafetyWeek 2025 Media Release
30/10/2025CommitteesMedicines Classification Committee - Dates and Deadlines
30/10/2025CommitteesAgenda for the 75th Medicines Classification Committee meeting
30/10/2025CommitteesComments on agenda items for the 74th meeting of the Medicines Classification Committee
30/10/2025CommitteesMinutes of the 74th meeting of the Medicines Classification Committee - 23 July 2025
22/10/2025Monitoring CommunicationM² Logo Estradot (estradiol) transdermal patches: reports of quality and efficacy concerns

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

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