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
Overview of the different types of MHRA safety communications about medicines, medical devices and other healthcare products, including what they are and who they are aimed at, and information on decision-making around safet…
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
A poster explaining the different symbols used on medical devices.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
Recommendations for prescribing methadone and buprenorphine to people in treatment for opioid dependence in England.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Guidance for manufacturers of IVC filters. It outlines specific scenarios that should be considered when determining if an incident is reportable.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
How to use PharmaQC to access pharmaceutical suppliers, Quality Control (QC) pharmacists and Commercial Medicines Unit (CMU) buyers.
Links to EU guidance, as it stood immediately before end of transition period.
How to apply for marketing authorisation via this new procedure.
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
Don’t 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).