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
Information on practical arrangements for notification, what should and should not be classified as a “serious breach” and what must be reported.
Information about the MHRA graduate scheme which is currently closed for applications.
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA provides advice for Retailers and Producers of e-cigarette / vape products.
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
How manufacturers should undertake a clinical investigation for a medical device to ensure they comply with medical device regulations.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to register as a manufacturer, importer or distributor of active substances.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Information about the MHRA's duties and how you can report a non-compliant medical device.
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
This guidance summarises our approach to pharmacovigilance
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
How to join the phase I accreditation scheme.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
How to renew marketing authorisations for products granted through different routes and at different times.
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).