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This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How the MHRA decides whether to approve a clinical investigation for medical devices.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
Fees payable to the MHRA from 2025.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Guidance on the deadlines for initial and response submissions.
You must get permission to export certain drugs and medicines.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Guidance on clinical trials that are categorised as ‘notifiable’.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
How to write clear and effective field safety notices (FSNs) for medical devices.
Do not include personal or financial information like your National Insurance number or credit card details.
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