For the marketing
authorisation of plasma-derived medicinal products, the plasma
master file (PMF) certification is used. The PMF is a
compilation of all the required scientific data on the quality, safety and
efficacy of human plasma relevant to the medicines, medical devices and
investigational products. These data cover all aspects of the use of plasma,
from collection to plasma pool.
The PMF is a separate set of documentation from the dossier for a
medicine’s marketing authorisation, and all applications should be submitted
electronically in Electronic
Common Technical Document (eCTD) format.
At Asphalion, we would be happy to support you with
the PMF preparation and submission to the EMA.
Contact us if you need any help at [email protected]