Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures.
Reynold D C FranciscaInge M ZomerdijkMiriam C J M SturkenboomSabine M J M StrausPublished in: Expert opinion on drug safety (2018)
During the study period, no significant differences in the proportion or trend of products with aRMMs at the time of licensing before and after the pharmacovigilance legislation were identified.
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