Andrew Marr assesses further the revised XEVMPD guidance from EMA

Andrew Marr assesses further the impact of the revised guidance on XEVMPD issued by EMA on 31 January 2014, together with subsequent revisions and additions.  The article looks at how companies should be responding to this guidance, how they should update their information and then prepare to maintain it..

A major exercise to update date to meet new requirements will be needed by MAHs.  Re-submission of all Authorised Medicinal Product and Organisation records will be required between 16 June and 31 December 2014 and then maintained within 30 calendar days of any change.

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This article was published in the June 2014 edition of Regulatory Rapporteur.