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Code is assigned. The QPPV code is maintained by the Agency’s EudraVigilance (EV) Registration
Team and can be retrieved from:
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The EudraVigilance website (restricted area accessible for registered users only) under "QPPV
list" (by Gateway/EVWEB users) or;
EudraVigilance look-up table in the XEVMPD Data Entry Tool (EVWEB) (by EVWEB users).
• If the requested QPPV does not exist in the XEVMPD, MAH shall contact the EudraVigilance
Registration Team to register the requested QPPV in EudraVigilance.
See section 1.3. of this document for further information on how to submit QPPV information in the
XEVMPD.
1.2.6. Pharmacovigilance System Master File Location (PSMFL) code (AP.6)
The Pharmacovigilance System Master File Location (PSMFL) code of the place where the
PSMF for the authorised medicinal product is located must be specified if the PSMFL
information was submitted in the XEVMPD and the PSMFL Code is available.
MFL EV Code is a unique code assigned by the eXtended EudraVigilance Medicinal Product Dictionary
(XEVMPD) to a specific PSMF and PSMF location.
• If the Master File Location information was previously successfully submitted in the XEVMPD and a
PSMFL EV Code has been assigned, the PSMFL can be selected from the available EudraVigilance
look-up table (EVWEB users). Gateway users should populate the 'MFL' field (AP.6) with the
assigned MFL EV Code received in the XEVPRM Acknowledgement.
• If the required Master File Location was not inserted in the XEVMPD, the Master File Location
information can be added using the Master File Location section of the XEVPRM.
Further information on what triggers the request of PSMFL EV Code and how to submit MFL
information in the XEVMPD are available in section 1.11. of this document.
1.2.7. Pharmacovigilance enquiry email (AP.7)
The email address where enquiries related to Pharmacovigilance can be submitted must be
specified.
The marketing authorisation holder needs to decide, which email address they wish to specify for
dealing with Pharmacovigilance enquiries. The contact information for Pharmacovigilance enquires (email
and phone) will be made public by the Agency.
1.2.8. Pharmacovigilance enquiry phone (AP.8)
The phone number where enquiries related to Pharmacovigilance can be directed must be
specified.
The marketing authorisation holder needs to decide, which phone number they wish to specify for
dealing with Pharmacovigilance enquiries. It may be the same as the phone number of the QPPV.
Detailed guidance on the electronic submission of information on medicinal products
for human use by marketing authorisation holders to the European Medicines Agency in
accordance with Article 57(2) of Regulation (EC) No. 726/2004
EMA/135580/2012 Page 34/163