16 May 2012

CSC: Beyond EVMPD - IDMP! - Joel Finkle

As we've been telling you, the EU requires that all marketed products must be registered with the Eudravigilance Medical Product Dictionary (EVMPD) in the new Extended format (XEVMPD, or rather XEVPRM for the Extended Eudravigilance Product Report Message). However, the EU recognizes that this is a stopgap measure. There's another standard called IDMP, for Identification of Medical Products, that's just on the horizon. IDMP was developed at Health Level Seven (HL7), and shares some components with Structured Product Labeling (SPL), which was also developed by HL7 -- namely the Common Product Model. It completed balloting as of April 23, 2012, as a Final Draft Standard, with the anticipation that it will be finalized by the end of the year – the development of an Implementation Guide being a major development still to be completed. The expectation is that it will be implemented in 2015 -- that should be a much more comfortable time for implementation than the EU gave for XEVMPD, but it will still be challenging.

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