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How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Guidance on the various types of modifications that can be made to a clinical trial approval.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
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.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Information on telecare monitoring systems and personal alarms that can help you stay safe and independent at home.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to get access to MHRA submissions portals, how to use them, where to go for help.
How to contact the MHRA for specific services or enquiries.
Device qualification and classification of ambient voice technology-enabled products that are medical devices intended to be placed on the market, or put into service, in Great Britain.
An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees.
How to help patients and their families reduce the risks of harm from opioid medicines.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Guidance on labelling for medicinal products used in clinical trials.
The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
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.
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