Revised: 2 October 2019

Information for Industry

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

Industry News

Date Type Title
6/12/2019PublicationsPrescriber Update Volume 40 Number 4 dated December 2019
4/12/2019Media ReleaseMedicines Classification Committee releases latest meeting minutes
4/12/2019CommitteesMinutes of the 63rd meeting of the Medicines Classification Committee held in Wellington on 10 October 2019
4/12/2019CommitteesMedicines Classification Committee - Dates and Deadlines
25/11/2019Media ReleaseTaking multiple medicines? Support the health care system by reporting suspected side effects this #MedSafetyWeek
21/11/2019CommitteesAgenda for the 180th Medicines Adverse Reactions Committee meeting - 5 December 2019
20/11/2019Alert CommunicationConsent to distribute Cafergot tablets (ergotamine tartrate 1 mg + caffeine 100 mg) will be prohibited under Section 36 of the Medicines Act 1981 on 1 May 2020
14/11/2019Monitoring CommunicationM² Logo Possible risk of vasculitis with dabigatran (Pradaxa)
12/11/2019Monitoring CommunicationUpdate 7 November 2019 - Breast Implants and anaplastic large cell lymphoma
12/11/2019Monitoring CommunicationSuspected adverse reaction reports to lamotrigine after changing brands
4/11/2019ConsultationConsultation on proposed changes to current warning and advisory statements for paracetamol
25/10/2019CommitteesMinutes of the 179th Medicines Adverse Reactions Committee Meeting
21/10/2019Monitoring CommunicationLosartan approved medicines supplied in New Zealand not affected by recalls overseas
21/10/2019Monitoring CommunicationReview of chemically synthesised active pharmaceutical ingredients for presence of nitrosamine impurity
21/10/2019Alert CommunicationMedicines containing ranitidine and a potential impurity, N-nitrosodimethylamine (NDMA)
16/10/2019CommitteesAgenda for the 108th meeting of the Medicines Assessment Advisory Committee - 13 November 2019
14/10/2019MedicinesPart 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
11/10/2019NoticesMedsafe Office Closure Christmas/New Year 2019/2020
11/10/2019Alert CommunicationSurgical Mesh Implants - Adverse Event Reporting and Monitoring - Link to the latests October 2019 report
9/10/2019PublicationsMedical Device Adverse Event Reporting

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