Licensing plasma master files and vaccine antigen master files
Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
This page is for licensing PMFs and VAMFs only. For biosimilars, see聽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鈥疢HRA at pmf@mhra.gov.uk.听 鈥�
罢丑别鈥疢HRA鈥痗ontinues to recognise the existing European Union (EU)鈥�PMFs鈥痑nd associated inspections until further notice.
罢丑别鈥�PMF鈥痟older must notify the鈥疢HRA鈥痮f the outcome of the annual updates within 4 weeks of the completion of the update by emailing pmf@mhra.gov.uk.听
For all initial and variation applications submitted to the鈥疎uropean Medicines Agency (EMA), the鈥�PMF鈥痟older must notify the鈥疢HRA鈥痮f the determination outcome of the application within 4 weeks of the determination date by emailing pmf@mhra.gov.uk.听
The MHRA鈥痳eserves the right to request further information if UK-specific public health issues are identified.听聽
VAMFs
No鈥痸accine antigen master file (VAMF)鈥痯rocedure is in place in the UK at present. Applicants proposing such a submission should contact the鈥疢HRA. 鈥犅�
Contact
For further information, contact the PMF mailbox at pmf@mhra.gov.uk or MHRA聽 Customer Services Centre at鈥� RIS.NA@mhra.gov.uk.