Andrew Marr assesses the changes and impacts of the revised XEVMPD guidance of 31 January 2014

Andrew Marr assesses the impact of the revised guidance on XEVMPD issued by EMA on 31 January 2014.

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 on 11 February 2014 in the on-line version of Scrip Regulatory Affairs.