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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.
The MHRA is ready to prioritise and provide any assistance for clinical trials applications submitted for COVID-19
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Types of test Virus test These tests (sometimes called ‘swab’ or ‘antigen’…
The Department of Health and Social Care (DHSC) has issued a policy paper…
Target Product Profile: Point of Care SARS-CoV-2 Detection Tests Version…
Target Product Profile Antibody tests to help determine if people have…
1. Target Product Profile 1.1 Enzyme Immunoassay (EIA) Antibody tests to…
Version control Version 1.0 Date issued October 2020 Description Initial…
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
How investigators and sponsors should manage clinical trials during COVID-19
How to contact MHRA for specific services or enquiries.
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to license a medicine for sale in the UK, including applications through national and international routes.
Guidance on how to get an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme and reporting problems with e-cigarettes.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Submissions related to human medicines need to be submitted directly to the MHRA.
What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Fees payable to the MHRA for 2020 to 2021
Pharmacovigilance system requirements
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
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