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
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.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
How to renew marketing authorisations for products granted through different routes and at different times.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
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.
Guidelines to help mitigate and manage medicine shortages.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
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.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
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 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).