Plasma Master File dossier requirements

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This page gives information on dossier requirements for Plasma Master File (PMF) applications.

All applications should be submitted electronically in electronic common technical document (eCTD) format to the European Medicines Agency and all coordinators' PMF contact points.

Please note that the Agency's policy on paperless submissions states that no paper applications should be submitted to the Agency or to national competent authorities.

Notes for applicants

  • Applicants should submit their application to the PMF contact point, with the exception of the Netherlands*. Please note that for countries where only PMF Coordinator is nominated, the PMF documentation should be addressed to his/her attention.
    * Dr. Pieter de Graeff - College ter Beoordeling van Geneesmiddelen – Graadt van Roggenweg 500, 3531 AH Utrecht, NETHERLANDS
  • Applications must arrive at the European Medicines Agency and to PMF contact point coordinators by the submission deadline.
  • Should any issue be raised at validation, an additional sequence need to be resubmitted as per above paragraph.
  • The Agency and national competent authorities also require a signed original paper copy of the cover letter. This should be submitted together with the paperless dossiers on CD-ROM in eCTD format.
  • At the time of the answers to the list of questions, applicants should apply the same principles as in the initial submission of the dossier, submitting the responses on CD-ROM in eCTD format. Tables should be re-submitted if there are any changes.

 

General regulatory guidance

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