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 the바카라 사이트疢HRA at pmf@mhra.gov.uk.听 바카라 사이트�
罢丑别바카라 사이트疢HRA바카라 사이트痗ontinues to recognise the existing European Union (EU)바카라 사이트�PMFs바카라 사이트痑nd associated inspections until further notice.
罢丑别바카라 사이트�PMF바카라 사이트痟older must notify the바카라 사이트疢HRA바카라 사이트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 the바카라 사이트疎uropean Medicines Agency (EMA), the바카라 사이트�PMF바카라 사이트痟older must notify the바카라 사이트疢HRA바카라 사이트痮f the determination outcome of the application within 4 weeks of the determination date by emailing pmf@mhra.gov.uk.听
The MHRA바카라 사이트痳eserves the right to request further information if UK-specific public health issues are identified.听聽
VAMFs
No바카라 사이트痸accine antigen master file (VAMF)바카라 사이트痯rocedure is in place in the UK at present. Applicants proposing such a submission should contact the바카라 사이트疢HRA. 바카라 사이트犅�
Contact
For further information, contact the PMF mailbox at pmf@mhra.gov.uk or MHRA聽 Customer Services Centre at바카라 사이트� RIS.NA@mhra.gov.uk.