PMF Application - User Site
Brief Introduction
The PMF DB system provided in this link is called PMF Application. This file includes the current PMF application form, its variation annex and annexes to the PMF as well as test kit information. The PMF DB application aims to give a common format to fill in the information on centres addresses and test kits, so this should significantly provide a better reliable and consistent data entry as well a better tool for controlling the information. The eCTD dossier structure and submission procedure does not change. When preparing for a new procedure submission, in addition, the PMF Holder/applicant will use this DB to fill in the relevant PMF data in the PMF application DB, export the file and submit to the EMA. The data in the file will then be imported in to the EMA PMF DB interface system. The PMF DB interface will serve EMA and NCAs to ease access and retrieval of information on centre and establishment as well as testing kits that are in use by all PMFs dossiers across all PMF procedure certificates.
Warning Notices:
- This is a pilot implementation phase aims to closely monitor the PMF DB also ensuring that the PMF evaluation procedure is not disrupted. Stakeholders are kindly asked to carefully monitor and report to EMA of any difficulties or possible bugs encountered.
- This software does not allow parallel ongoing submissions, and prior to submit a new procedure the previous application needs to be closed. PMF holders should ensure that there are no overlap submissions and therefore plan well in advance their submissions.
- The PMF application includes an annex VI, where the PMF applicant/holder is invited to include the fractionation plants.
- The current PMF DB software includes separately the centres as blood centres or testing centres and need to be, when relevant twice. Information entered in the initial submission will be carried over unless it is deleted.
System
- All enquires, please contact Silvia Domingo Roige
Contact person
Silvia Domingo Roige | Quality of Medicines - silvia.domingo@ema.europa.eu