MHRA Updates UK Medicine Marketing Authorisation Application Process

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. An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees. Added a link to the new electronic Application Forms (eAFs) guidance page Removed two out of date webinars from 2024. Added guidance on electronic submissions to the MHRA. Video removed to make the guidance on how to apply for a licence clearer. Added text and youtube link before overview - Added section numbers and document overview - Updated all sections for clarity and removal of outdated territorial information - Updated links to further guidance documents Added a new webinar video on the established medicines licensing process Added details of Lorenz Docubridge validation tool. Edited to add Youtube tutorial for Established Medicines licensing process Details about new process changes which are being introduced for applications for “Established Medicines”. Updated to add further guidance on obtaining a PL number for applications Added link to Fees Calculator. Added 'Checklist and abstract for bioequivalence studies and/or biowaivers' and 'Checklist for product information', for established active substance MAAs within scope. Added links to pages providing further information on some of the procedures. Following the end of the transition period, published information on new procedures for obtaining a marketing authorisation in the UK, Great Britain (England, Scotland and Wales) or Northern Ireland. Updated content to reflect that the UK cannot act as a Reference Members State (RMS) for approval of marketing authorisations in decentralised and mutual recognition licensing procedures during the transition period. The DHSC contact for fast-tracking a licence has changed. Inserted text - Request for Information (RFI)... Under 'Ways to make your submission' Updated email address and naming to Department of Health and Social Care Removed link to Excel spreadsheet list of products. Added spreadsheet under "types of application" heading Added a link to the User Guide for the electronic application form. Updated contact information for Department of Health for advice when seeking to fast-track an application due to a shortage of supply of essential medicines. New fees calculator. This information is common to all routes of application. Read the guidance for a specific pathway for any extra information or steps that might be required. The pathway that is followed will depend on the type of application being made. Find out more about the different national and international procedures . The MHRA continues to accept electronic Application Forms ( eAFs ) for UK medicines licensing applications. As an interim business continuity measure, MHRA is making the current eAF forms available for applicants to download and use. Electronic Application Forms ( eAF ) for UK Medicines Licensing Applications Existing submission routes, validation requirements and assessment processes remain unchanged. All UK MA applications should be submitted through the MHRA Submissions Portal. Accessing and using the MHRA submissions portal Any questions about the Submissions Portal should be sent by email to submissions@mhra.gov.uk . The application should be submitted using the electronic Common Technical Document ( eCTD ) . The pre-submission checklist (PDF, 129 KB, 7 pages) and the eAF and cover letter tool should be used to determine what documents and information to include in the application. If the correct documents and information are not submitted the application wi