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Clinical trials for medicines: apply for authorisation in the UK

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ByMedicines and Healthcare products Regulatory Agencylunar_lark_d5b6e2

How to apply for a clinical trial (prior to 28 April 2026) including eligibility, phases, model IMPDs, costs and how to make changes to your application.

Adapted edition

Medical device safety
Document type
Reference Guide
Format
DOCX
Pages
13
Language
English
Version
1.0
Updated
2026-09-17
Category
Safety & operations
Licence
Open Government Licence v3.0
Description

How to apply for a clinical trial (prior to 28 April 2026) including eligibility, phases, model IMPDs, costs and how to make changes to your application. Consult the original guidance for current legal and operational details.

Contents
  • Clinical trial definition
  • Clinical trial authorisation
  • What this guidance does not cover
  • Medical devices
  • Borderlines
  • Sponsor a clinical trial
  • Registering your clinical trial
  • Notifying the authorities of your registry number
  • Submit your clinical trial application
  • Applications for an investigational medicinal product and medical device (IMP+Device)
  • In vitro diagnostic (IVD) devices including companion diagnostic devices
  • About the application process
  • Where this guidance does and does not apply
  • Documents to send with your application
  • Covering letter
  • Investigational medical product dossier
Source and licence
Clinical trials for medicines: apply for authorisation in the UK

Medicines and Healthcare products Regulatory Agency

Original source OGL-UK-3.0

AttributionMedicines and Healthcare products Regulatory Agency, ‘Clinical trials for medicines: apply for authorisation in the UK’ (updated 31 March 2026), reused under the Open Government Licence v3.0.

ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.

Version history
  • v1.017/09/2026
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