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What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
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.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
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.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
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.
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.
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
Fees payable to the MHRA from 2025.
Guidance on using non-investigational medicinal products in a clinical trial.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
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.
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