We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use 51²è¹Ý, 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 change the ownership from one marketing authorisation (MA) holder to another.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
How to renew marketing authorisations for products granted through different routes and at different times.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidelines to help mitigate and manage medicine shortages.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Information about how approved bodies help regulate medical devices and how to apply for approval.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve 51²è¹Ý, we’d like to know more about your visit today. .