EUROmediCAT Recommendations for European Pharmacovigilance concerning safety of medication use in pregnancy.

This paper sets out the Recommendations from the EUROmediCAT project for European and national medicines regulatory agencies, public health authorities and professional clinical bodies o To improve future pharmacovigilance o To inform future drug safety measures The recommendations are designed to help make better use of current data, networks and infrastructures in Europe, to achieve a more integrated system and better dissemination of knowledge and to raise the level of reproductive pharmacovigilance to meet women's reasonable expectations. These recommendations concentrate particularly on safety in early pregnancy in relation to the risk of congenital anomalies. Wider perspectives should also be taken with respect to other adverse pregnancy outcomes (such as miscarriages, preterm birth or intrauterine growth retardation) and particularly neurobehavioural effects of medication exposure in pregnancy, with respect to the effects of the diseases/conditions themselves on pregnancy outcome, with respect to herbal medications and with respect to the period of lactation, but these are not the specific focus of these recommendations.