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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.
Guidance on labelling for medicinal products used in clinical trials.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
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.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
Guidance on the various types of modifications that can be made to a clinical trial approval.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Guidance on transitional arrangements for the Clinical Trials Regulations.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
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