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Submitting via MHRA Submissions portal

Submitting via MHRA Submissions portal Agenda Item Intro The MHRA Submissions homepage Submitting e-cigarettes Submitting via Human Medicines Submitting PSURS. Submitting PIPs Next Steps 2 OFFICIAL. Introductions 3 OFFICIAL. This webinar The requirements and proposals we are presenting are drafts, and do not at this stage represent Government policy. This session is to provide information and can be shared with colleagues. This Webinar is to showcase and answer questions on the technical process of Submitting information. 4 OFFICIAL. Webinar purpose This webinar will focus on MHRA Submissions Providing an overview of MHRA Submissions Homepage How to raise a query from the MHRA Submissions Homepage and find support documents Submitting marketing authorisation and Clinical trial applications via the Human Medicines tile Submitting PSURs Submitting PIPs Submitting e-cigarette notifications Next steps 5 OFFICIAL

Development Safety Update Reports BROMI Self Certification - Notification 61(3) Notified Body Designation ... Article 45 - Paediatric submission Early Access to Medicines UK Export Certificates CCC Procedure UK. 14 OFFICIAL ... Please note - For all new clinical trial submissions post 1st Jan 2021 your Application Form ...

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