Apply for a licence to market a medicine in the UK

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) provides comprehensive guidance for pharmaceutical companies seeking Marketing Authorisations (MA) in the United Kingdom. Effective from March 1, 2024, for established medicines, this framework mandates the use of the MHRA Submissions Portal and the electronic Common Technical Document (eCTD) format, adhering to international ICH standards. Applicants must obtain a Product License (PL) number prior to submission, noting that PLGB prefixes will be replaced by UK-wide licensing starting January 1, 2025. Key requirements include the timely submission of Active Substance Master Files (ASMF) and the strict use of the MHRA’s specific Summary of Product Characteristics (SmPC) template. For established medicines, specific checklists for bioequivalence and product information are required to ensure submissions are complete upon initial assessment. Common issues leading to application rejection include incomplete documentation, failure to use mandated templates, or non-compliance with the Human Medicines Regulations 2012. While fast-tracking is available for public health emergencies or critical supply shortages, it requires formal justification and prior coordination with the Department of Health and Social Care. Compliance also extends to financial obligations; failure to provide purchase orders or settle invoices promptly may result in license suspension or legal action. To avoid delays, the MHRA recommends using technical validation tools before submission to ensure all regional requirements are met.