Eudralex Volume 9 Product- or Population-Specific Considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk
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Eudralex Volume 9 Product- or Population-Specific Considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk
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This Product- and Population-Specific Considerations Chapter P.III of GVP provides guidance to marketing authorisation holders (or applicant where applicable), competent authorities of Member States and the Agency on conducting pharmacovigilance processes for the populations of pregnant or breastfeeding women (or individuals).