Purple Vigilance can now provide XEVMPD services

We are pleased to announce that as of today, Purple Vigilance is able to offer a new service; we can now assist Marketing Authorisation Holders (MAHs) and Sponsors with data entry and maintenance of products details in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).

Background on the XEVMPD

One of the key deliverables of the 2010 Pharmacovigilance legislation relates to the submission by MAHs of information about medicines to the European Medicines Agency (EMA). The requirement is described in Article 57(2) of Regulation (EC) No 1235/2010.

It requires:

  • MAHs to submit information to the EMA electronically on all medicinal products for human use authorised in the European Union by 2 July 2012, using this format;
  • MAHs to inform the EMA of any new or varied marketing authorisations granted in the EU as of 2 July 2012, using this format.

Purple Vigilance can enter the details of your products onto XEVMPD and provide on-going maintenance to ensure continued compliance.

Contact us now to discuss your requirements!

European Medicines Agency Publishes Updated Set of Mandatory Article 57(2) Requirements & FAQ Document

The EMA has published an updated set of mandatory Article 57(2) requirements for Marketing Authorisation Holders (MAHs) today. Article 57 relates to the population of the XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) and the new document details the revised mandatory fields in the XEVMPD that must be populated by 2nd July 2012.

A Frequently Asked Questions document on the eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) has also been published today.

Further information and the documents can be found using the following links:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/03/news_detail_001459.jsp&mid=WC0b01ac058004d5c1

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000336.jsp&mid=WC0b01ac05804d8b2b