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
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations and clinical variations innovative medicines.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to renew marketing authorisations for products granted through different routes and at different times.
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
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.
How to change the ownership from one marketing authorisation (MA) holder to another.
Guidelines to help mitigate and manage medicine shortages.
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Information about how approved bodies help regulate medical devices and how to apply for approval.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
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.
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).