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How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
Guidance on labelling for medicinal products used in clinical trials.
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
A guide to the legislation enabling drug services and others to supply take home naloxone without a prescription to save a life in an emergency.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
Guidance on the various types of modifications that can be made to a clinical trial approval.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Information on telecare monitoring systems and personal alarms that can help you stay safe and independent at home.
How to contact the MHRA for specific services or enquiries.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
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