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How to apply for a clinical trial from 28 April 2026, 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.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
How to write clear and effective field safety notices (FSNs) for medical devices.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Guidance on labelling for medicinal products used in clinical trials.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
How to conform with the legal requirements for placing medical devices on the market.
The call for application for phase 2 of the AI Airlock is now open. This page contains information on eligibility and how to apply
Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
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