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
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Guidance on the deadlines for initial and response submissions.
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
How to change the ownership from one marketing authorisation (MA) holder to another.
The MHRA provides advice for Retailers and Producers of e-cigarette / vape products.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
New Cosmetic Breast Augmentation Risk Awareness Tool for patients to use when considering cosmetic breast implant surgery.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Guidelines to help mitigate and manage medicine shortages.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
How to renew marketing authorisations for products granted through different routes and at different times.
Clinical trial applications that need expert advice from a specialist group or committee.
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
Comply with good pharmacovigilance practice and prepare for an inspection.
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).