# Licensing plasma master files and vaccine antigen master files

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/56373413-e6ba-479d-b1eb-16feeef870c7
Type: Detailed Guide
Published: February 27, 2025

> The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the licensing of Plasma Master Files (PMFs) and Vaccine Antigen Master Files (VAMFs) in the United Kingdom. As this is a general regulatory document rather than an inspection report, it does not list a specific company, inspection dates, or violations; instead, it establishes the mandatory framework for all participating entities. The MHRA continues to recognize existing European Union PMFs and their associated inspections for the time being but requires national applications for new submissions. Under this framework, PMF holders must notify the MHRA of the outcomes of annual updates and any European Medicines Agency (EMA) determinations within four weeks of completion. For VAMFs, no formal UK procedure currently exists, and applicants must contact the agency directly for guidance. Required actions for compliance include strict adherence to these notification windows via the designated PMF mailbox. The MHRA maintains the authority to request further information if specific UK public health issues are identified. This guidance ensures that the MHRA retains oversight of biological materials while maintaining temporary continuity with established European standards.

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## Content

This page is for licensing PMFs and VAMFs only. For biosimilars, see Guidance on the licensing of biosimilar products . For ATMPs, see Advanced therapy medicinal products: regulation and licensing in UK . PMFs The MHRA accepts national PMF applications. Applicants proposing such a submission should contact the MHRA at pmf@mhra.gov.uk . The MHRA continues to recognise the existing European Union (EU) PMFs and associated inspections until further notice. The PMF holder must notify the MHRA of the outcome of the annual updates within 4 weeks of the completion of the update by emailing pmf@mhra.gov.uk . For all initial and variation applications submitted to the European Medicines Agency (EMA), the PMF holder must notify the MHRA of the determination outcome of the application within 4 weeks of the determination date by emailing pmf@mhra.gov.uk . The MHRA reserves the right to request further information if UK-specific public health issues are identified. VAMFs No vaccine antigen master file ( VAMF ) procedure is in place in the UK at present. Applicants proposing such a submission should contact the MHRA. Contact For further information, contact the PMF mailbox at pmf@mhra.gov.uk or MHRA Customer Services Centre at RIS.NA@mhra.gov.uk .