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.

Licensing plasma master files and vaccine antigen master files