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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.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance on the various types of modifications that can be made to a clinical trial approval.
Guidance on labelling for medicinal products used in clinical trials.
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.
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
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.
How to contact the MHRA for specific services or enquiries.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
How to help patients and their families reduce the risks of harm from opioid medicines.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
How to manage and use bed rails safely.
You must get permission to export certain drugs and medicines.
Information relating to good clinical practice (GCP) inspections.
How to conform with the legal requirements for placing medical devices on the market.
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