Tag Archive for: Article 57(2)

XEVMPD – Frequently Asked Questions

Which medicinal products fall within the scope of Article 57 (2) and need to be reported in xEVMPD ?

All medicine products authorized in the EU (national authorizations, MRP, DCP, CP) must be reported via an Extended EudraVigilance Product Report Message (xEVPRM). Registrations in EEA countries not belonging to the EU (Iceland, Liechtenstein and Norway) must also be reported.


Which medicinal products are not covered by Article 57 (2) and must not be reported in xEVMPD?

  • Drugs without valid registration
  • Traditional herbal medicines
  • Homeopathics
  • Drugs that are sold on named-patient basis
  • Parallel import drugs
  • Drug registrations outside the EEA


Do Drugs that are registered, but not marketed, need to be reported in xEVMPD?

Yes. Regardless of the marketing status, valid registrations must be submitted to xEVMPD.


According to Article 57 (2), do veterinary products (veterinary medicinal products) have to be reported to the xEVMPD?

No. The obligation only applies to human medicinal products.


Do German “Standardzulassungen” have to be reported according to the xEVMPD Guideline?

Yes. Standardzulassungen are evaluated in the same way as other national registrations and have to be included in xEVMPD.


In Germany, there are so-called “fictitious authorizations”, for which there is no registration date. Must these be included in xEVMPD?

No. “Fictitious authorizations” under EU law are not valid registrations and are not subject to the xEVMPD-duty.


How often do I have to update the xEVMPD database?

Information on any amendments to the terms of marketing authorisations following variation, transfer, renewal, suspension, revocation or withdrawal must be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised.


Questions and answers drawn from: EMA/159776/2013 “Electronic submission of Article 57(2) data – Questions & Answers (Q&As)”, 08.07.2014