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
Register to vote Register by 18 June to vote in the General Election on 4 July.
Submission dates and how the submissions using the EC decision reliance procedure work.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How the MHRA makes decisions on what is a medicinal product (borderline products).
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Submissions related to human medicines need to be submitted directly to the MHRA.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
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.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
The Veterinary Medicines Directorate may suspend or expire a licence to market an animal medicine if it fails to comply with the regulations.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
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).