Applying for a UK Marketing Authorisation for Medicines

Overview

This guidance provides an overview of the process for submitting or fast-tracking a marketing authorisation application, naming the medicine, and paying fees, applicable to all procedures. Specific pathways depend on the type of application; refer to additional guidance for national and international procedures. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Application Process

All UK marketing authorisation applications must be submitted via the MHRA Submissions Portal. Use the electronic Common Technical Document (eCTD) format; submissions are validated using the Lorenz Docubridge tool aligned with ICH standards and eCTD 3.2 requirements. Use the pre-submission checklist and eAF and cover letter tool to ensure complete documentation; incomplete submissions will not be validated. For questions, contact ris.na@mhra.gov.uk. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

PL Number

Required for UK or Northern Ireland licences; request via MHRA Portal or email PLNumberAllocation@mhra.gov.uk before submission. Prefixes include PL (whole UK), PLNI (Northern Ireland only), PLGB (not issued from 1 January 2025; existing ones cover whole UK). Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Active Substance Master Files (ASMFs)

ASMFs must be submitted by holders to MHRA before or with the application; applications are invalid without them. New ASMFs and updates submitted via MHRA Submissions; updates must be versioned. Certificates of Suitability (CEPs) are acceptable for UK national authorisations. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Summary of Product Characteristics (SmPC)

Submit in correct format using the SPC template; unaltered templates required, or submission rejected. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Established Medicines

Applies to established active substance marketing authorisation applications (MAAs). Ensure completeness per guidance on licensing process changes effective 1 March 2024. Watch webinars for details. Use checklists for bioequivalence studies/biowaivers and product information to promote 'right first time' submissions. UK Public Assessment Report (UKPAR) templates provided for various types of applications. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Providing a Name for a Medicine

MHRA reviews each application to ensure safe and correct use; follow naming guidance. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Fast Tracking a Marketing Authorisation

Available for public health emergencies or verified shortages of essential medicines by DHSC. Request via email to RIS.NA@mhra.gov.uk with justification and supporting evidence. For shortages, discuss with DHSC first. No additional fee. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Rejection

Incomplete submissions are rejected; reasons emailed, resubmission required with corrections. No charge if fails technical validation. Appeal to ris.na@mhra.gov.uk. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Fees

Vary by type/route; use fees calculator. Pay invoices upon receipt post-validation; penalties for non-payment. Provide relevant PO to MHRA before invoice. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Updates

Last updated 24 February 2026: Video removed for clarity. Other updates include additions of sections, checklists, and process changes for established medicines. Source: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk