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How to get access to MHRA submissions portals, how to use them, where to go for help.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
The call for application for phase 2 of the AI Airlock is now open. This page contains information on eligibility and how to apply
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guidance on labelling for medicinal products used in clinical trials.
How to write clear and effective field safety notices (FSNs) for medical devices.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Guidance on transitional arrangements for applying for clinical trial approval.
Guidance on using non-investigational medicinal products in a clinical trial.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Guidance on the various types of modifications that can be made to a clinical trial approval.
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…
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product licence submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched …
How to conform with the legal requirements for placing medical devices on the market.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
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