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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.
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Information relating to good clinical practice (GCP) inspections.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
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.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
How to contact the MHRA for specific services or enquiries.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance on the various types of modifications that can be made to a clinical trial approval.
How to get access to MHRA submissions portals, how to use them, where to go for help.
Information on telecare monitoring systems and personal alarms that can help you stay safe and independent at home.
Supporting information to accompany the National Patient Safety Alert on patient hoists and slings NatPSA/2026/005/MHRA.
How to help patients and their families reduce the risks of harm from opioid medicines.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance on labelling for medicinal products used in clinical trials.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
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