Pharmacovigilance Glossary Terms

SDEA (Safety Data Exchange Agreement): Written legal agreement between the Marketing Authorization Holder and any subcontractor (pharmacovigilance, manufacturer, licensing partners) that assure any safety information concerning licensed medicinal products will be reported to the MAH so legal reporting requirements can be met.

For pharmacovigilance subcontractors, within this agreement, responsibilities concerning pharmacovigilance activities are clearly stated, granting that an appropriate pharmacovigilance system is in place and that all legal requirements are fulfilled.