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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