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MHRA New Tool for Marketing Authorisation Applicants |IRP - 0 views

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MHRA-IRP-eligibility-checker Marketing-Authorisation-Application IRP-route-A-or-B How-to-use-MHRA-eligibility-checker What-is-the-IRP-route-A-or-B MHRA-regulatory-partners

shared by pharmacybiz on 22 Nov 23 - No Cached
  • pharmacybiz on 22 Nov 23
     
    The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new tool to check the eligibility for marketing authorisation applicants. Applicants are now required to use the online 'Eligibility Checker' tool to determine whether their Marketing Authorisation Application (MAA) is suitable for the Agency's International Recognition procedure (IRP), which will become operational on 1 January 2024. The tool will also help applicants identify which route (A or B) to follow, before submitting their IRP application. Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said that the tool has been tailored to "facilitate a smooth and efficient process for marketing authorisation applicants."
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