We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use ÌìÃÀÓ°Ôº, 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 comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
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.
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.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidelines to help mitigate and manage medicine shortages.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
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.
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.
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…
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve ÌìÃÀÓ°Ôº, we’d like to know more about your visit today. .