Andrew Marr re-assesses the impact of the revised guidance on XEVMPD issued by EMA on 5 March 2012
XEVMPD data are still required to be submitted to EMA for all authorised medicinal products in Europe by 2 July 2012 but the scope of the data required is reduced.
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This article was published on 15 March 2012 in the on-line version of Scrip Regulatory Affairs.