xEVMPD: extended EudraVigilance medicinal product dictionary (Article 57 database)
The xEVMPD, or Article 57 database, is EMA's record of every medicine authorised in the EU, which holders must keep updated within 15 days of changes.
Article 57(2) of Regulation (EC) No 726/2004, as amended by Regulation (EU) No 1235/2010, requires marketing authorisation holders to submit electronically to EMA information on all medicinal products for human use authorised in the Union, and to keep it up to date. EMA collects that information in the extended EudraVigilance medicinal product dictionary, usually called the xEVMPD or the Article 57 database. The initial population was due by 2 July 2012, and the obligation continues for every new authorisation and every relevant change.
An xEVMPD record describes the authorised product rather than the pack on the shelf: the holder, the authorisation number and procedure, the name, pharmaceutical form and strength, the active substances and excipients, the route, the authorised indications coded in MedDRA, the QPPV and the pharmacovigilance system master file location, and the attached product information documents. Holders submit through the EudraVigilance gateway or the EVWEB interface in the EVPRM message format, and EMA validates the message and returns an acknowledgement. The data feeds EudraVigilance case processing, signal detection, the EU reference date list, fee calculations and the EU's shortage and supply work.
The Article 57 database is also the bridge to ISO IDMP. EMA has been migrating product data into the Product Management Service in the PLM Portal, and the long-term plan is for structured product submissions there to replace xEVMPD maintenance. Until EMA switches a procedure or a data element over, the Article 57 obligation stands as written, and holders should expect a period in which both the xEVMPD record and the PMS record need to be kept consistent with the authorisation.
What goes wrong: a variation changes the indication or the holder and the xEVMPD record is updated months later or not at all; a product is withdrawn in one Member State but still listed as authorised; the QPPV named in the record left the company; and substance names entered as free text do not match the EMA substance list, so the record fails validation. Because EMA uses the data to calculate pharmacovigilance fees and to decide which holders a referral or PSUSA concerns, inaccurate records cause wrong invoices and missed obligations as well as inspection findings.
Timing
New marketing authorisations and changes to the information held in the database must be submitted within 15 calendar days of the date of the authorisation or of the authority's decision on the change. EMA's acknowledgement states whether the message was accepted; a negative acknowledgement means the submission has not been made and must be corrected and resent within the same deadline.
Used in
Holders reconcile Article 57 records when they can see every authorisation and its current status in one register, which is what Atlas is for.
Related terms
- SPOR: substances, products, organisations and referentialsSPOR is EMA's set of four master data services (substances, products, organisations, referentials) that implement ISO IDMP for EU regulatory submissions.
- EudraVigilance: EU adverse reaction databaseEudraVigilance is the EU system for collecting, managing and analysing suspected adverse reaction reports for medicines authorised in the EEA.
- QPPV: qualified person responsible for pharmacovigilanceThe QPPV is the named individual, resident in the EU, who is personally responsible for a marketing authorisation holder's pharmacovigilance system.
- PSMF: pharmacovigilance system master fileThe pharmacovigilance system master file (PSMF) is the holder's detailed description of its pharmacovigilance system, kept in the EU for inspectors.
- PLM Portal: EMA product lifecycle management portalThe PLM Portal is EMA's product lifecycle management platform for electronic application forms and eSubmissions for centrally authorised products.
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