Regulatory Open Forum

 View Only

  • 1.  Marketing Authorization Application in the UK post Brexit and Swissmedic

    Posted 26-Mar-2023 07:22

    Hi All

    Does anyone has any recent experience with the Market Authorization Application submission requirements in the UK and Swissmedic timelines as their websites are a bit confusing to me. Any recent flowchart or guidance?

    Thank you

    Anne 



    ------------------------------
    Anne Njapa, PharmD, MBA
    Cary, NC
    United States
    ------------------------------


  • 2.  RE: Marketing Authorization Application in the UK post Brexit and Swissmedic

    Posted 26-Mar-2023 23:36

    Anne, 

    For the UK: 

    For Devices: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1137842/Device_Registration_Reference_Guide_Feb_2023_Final_v1.pdf

    For Medicines I find the pre-submission checklist very helpful: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/368314/Pre-submission_checklist.pdf



    ------------------------------
    Stephanie Christianson, PhD
    Senior Regulatory Affairs Product Manager
    Kimberly-Clark
    Remote - Durham, NC
    United States
    ------------------------------

    Original Message


  • 3.  RE: Marketing Authorization Application in the UK post Brexit and Swissmedic

    Posted 27-Mar-2023 09:31

    Good morning Stephanie!

    Thank you kindly for the UK references.

    Have a great day!

    Anne



    ------------------------------
    Anne Njapa
    Cary NC
    United States
    ------------------------------

    Original Message


Related Content