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What's New

The process for reporting Medical Device Incidents has changed

We have updated the form used to record medical device incident reports and the way we manage these. We have done this to improve the efficiency of the reporting process, ensuring we investigate medical device incidents in a risk-proportionate way.

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News and Events

Date Type Title
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 CommunicationMedsafe is issuing a warning that Valentus SlimROAST Optimum Dark Roast Coffee should not be consumed - statement under section 98 of the Medicines Act 1981
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
8/10/2019NoticesNotice of Medsafe Office Closure Christmas/New Year 2019/2020
1/10/2019ConsultationOutcome of consultation on the changes to the prescribing restrictions of riluzole
25/09/2019Dear Healthcare Professional LetterMMR II Vaccine - Additional supply of MMR II measles, mumps and rubella vaccine: differences in labelling and package inserts
23/09/2019Alert CommunicationMedicines containing ranitidine and a potential impurity, N-nitrosodimethylamine (NDMA)
19/09/2019Monitoring CommunicationUpdate - Mē Logo Possible risk of lichen planus or lichenoid drug eruption with zoster (shingles) vaccine or influenza vaccine
6/09/2019CommitteesComments on agenda for the 63rd Medicines Classification Committee meeting
5/09/2019PublicationsPrescriber Update Vol.40 No.3 5 September 2019
30/08/2019CommitteesAgenda for the 179th meeting of the Medicines Adverse Reactions Committee