We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
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.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Supporting guidance, publications and resources on the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making for medicines and medical devices in the UK.
Patient factsheet providing information on influenza (flu) and flu vaccination.
Fees payable to the MHRA from 2025.
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.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
You must get permission to export certain drugs and medicines.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
A series of explainers to help you understand the parts of the MHRA Strategy to 2030 most relevant to you, and what they mean in practice.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Do not include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab and requires JavaScript).