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
Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable.
For manufacturers reporting adverse incidents with neurostimulators under the vigilance system.
The MHRA hosted a live Ask Me Anything on how artificial intelligence (AI) is being regulated in healthcare.
This publication supports local authority health and wellbeing boards to develop and update pharmaceutical needs assessments (PNAs).
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
Information relating to the disapplication of falsified medicines under UK Law.
The MHRA’s Innovation Office offers access to expert regulatory guidance for developers of innovative medicines and novel manufacturing processes that face regulatory challenges, uncertainties, or gaps in the current regulat…
How to carry out the biological safety evaluation, which is required before undertaking a clinical investigation for a medical device.
Which product type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
The types of emissions a manufacturer or importer of e-cigarettes should notify us about.
How to test and report levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
VDEC works with global leaders from all sectors to develop and deliver the vaccine and therapeutic products we need to protect us from infectious diseases.
Industry webinars on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Industry must notify the MHRA if they will not be using these flexibilities
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
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).