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 theĀ 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