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How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Information and recommendations for manufacturers on the preparation and presentation of a post market surveillance report (PMSR).
Guidance on the various types of modifications that can be made to a clinical trial approval.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
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'
How to make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
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.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
How to conform with the legal requirements for placing medical devices on the market.
Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
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