06 March 2012

Pharma eReport Blog: Updated EVMPD guidance from EMA – so what next?

The EMA has just published the long-awaited update to its EVMPD guidance, covering specifications, controlled vocabularies and more.  As anticipated, and following the discussions at the 30th January cross-industry meeting, the EMA has elected to go with “Option 3” – a significantly reduced subset of information now required to meet the xEVMPD compliance deadline of 2nd July 2012.

In a revision of its previous requirements, the EMA has decided to reduce the number of mandatory data elements, in response to European pharmaceutical industry feedback regarding the practical challenges of compliance by July 2012.   The EMA has therefore decided not to request submission of the following data elements for medicinal products by the July 2012 deadline:

    * indication if the product is subject to additional monitoring
    * location of the pharmacovigilance system master file
    * description of packaging information
    * Structured Substance Information (SSI) data reporting

To find more information please use the below mentioned weblink

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