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
How to renew marketing authorisations for products granted through different routes and at different times.
How to change the ownership from one marketing authorisation (MA) holder to another.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
Guidelines to help mitigate and manage medicine shortages.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
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.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
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.
Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Information about how approved bodies help regulate medical devices and how to apply for approval.
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).