MHRA Updates UK Medicine Marketing Authorisation Application Guidance

• The MHRA has significantly updated its guidance for UK medicine marketing authorisation applications, including new eAF guidance and clarified electronic submission requirements.
• All UK marketing authorisation applications must now be submitted through the MHRA Submissions Portal using the eCTD format, with specific checklists provided to ensure compliance.
• New resources, including webinars and tutorials, are available for the UK established medicines licensing process, alongside an updated fees calculator and guidance on fast-tracking applications.
• Post-transition period procedures for Great Britain and Northern Ireland are detailed, clarifying the UK's role in international licensing processes as it cannot serve as a Reference Member State for EU procedures.
• Applicants must consult specific pathway guidance, as the application route depends on the medicine type, with updated contact information for the Department of Health and Social Care.

All UK marketing authorisation applications must now be submitted exclusively through the MHRA Submissions Portal, with any queries regarding its use directed to submissions@mhra.gov.uk.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued significant updates to its guidance for obtaining a UK medicine marketing authorisation application. These revisions aim to streamline the application process, enhance clarity, and reflect post-Brexit regulatory changes. The comprehensive overhaul includes the addition of a new guidance page for electronic Application Forms (eAFs) and the removal of outdated webinars from 2024, ensuring applicants access the most current information.

Further efforts to improve user experience include the removal of a previous video to make the application guidance more straightforward, alongside the introduction of new text and a YouTube link preceding the main overview. All sections have been updated for enhanced clarity, with outdated territorial information removed, and links to supplementary guidance documents have been refreshed. These changes collectively underscore the MHRA's commitment to providing a clear and efficient pathway for pharmaceutical market entry in the UK.

A critical aspect of the updated guidance for a UK medicine marketing authorisation application is the emphasis on electronic submissions. The MHRA continues to accept electronic Application Forms (eAFs) for all UK medicines licensing applications, making current eAF forms available for download as an interim business continuity measure. It is crucial for applicants to note that all UK marketing authorisation applications must now be submitted exclusively through the MHRA Submissions Portal, with any queries regarding its use directed to submissions@mhra.gov.uk.

Applications are required to be submitted using the electronic Common Technical Document (eCTD) format. To ensure compliance and avoid rejection, applicants must utilize the pre-submission checklist, a seven-page PDF document, alongside the eAF and cover letter tool. These resources are designed to help determine the precise documents and information necessary for a complete submission, as applications lacking the correct documentation will not be processed. Existing submission routes, validation requirements, and assessment processes remain unchanged despite these new electronic mandates, reinforcing the importance of adhering to the specified MHRA eAF submission guide and MHRA Submissions Portal guidance.

The MHRA has also introduced specific guidance and resources for various application types, particularly for the UK established medicines licensing process. This includes a new webinar video and a YouTube tutorial dedicated to the established medicines licensing process, detailing new procedural changes for these applications. Further guidance has been added concerning the acquisition of a PL number for applications, alongside a direct link to the UK marketing authorisation fees calculator.

For established active substance marketing authorisation applications within scope, new checklists have been provided, specifically 'Checklist and abstract for bioequivalence studies and/or biowaivers' and 'Checklist for product information'. The guidance also covers procedures for fast-tracking applications, noting a change in the Department of Health and Social Care (DHSC) contact for such requests. Updated contact information for the Department of Health is also provided for advice when seeking to fast-track an application due to a shortage of essential medicines, and new text regarding Requests for Information (RFI) has been inserted under 'Ways to make your submission'.

Following the end of the transition period, the MHRA has published comprehensive information on new procedures for obtaining a marketing authorisation across the UK, encompassing Great Britain (England, Scotland, and Wales) and Northern Ireland. This guidance clarifies that the UK cannot serve as a Reference Member State (RMS) for the approval of marketing authorisations within decentralised and mutual recognition licensing procedures, reflecting its independent regulatory status post-Brexit. The information provided is common to all application routes, but applicants are advised to consult specific pathway guidance for any additional requirements or steps.

The pathway chosen for a UK medicine marketing authorisation application will depend on the specific type of application being made, with further details available on national and international procedures. The Department of Health and Social Care's email address and naming have been updated, and a spreadsheet detailing product types has been added under the 'types of application' heading, replacing a previously linked Excel spreadsheet list. A user guide for the electronic application form has also been added, further supporting pharmaceutical companies navigating Great Britain medicine market entry.

Lawyers and compliance officers advising pharmaceutical clients on market entry in the UK must review the updated MHRA guidance on marketing authorisation applications, particularly regarding electronic submission requirements, the MHRA Submissions Portal, and specific procedures for established medicines, to ensure compliance and efficient processing.

Source: Original reporting via GOV.UK guidance updates