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BREXIT – Key changes in the pharmacovigilance system

      The United Kingdom (UK) has left the European Union (EU), and the transition period after Brexit will come to an end on 31 December 2020. By the end of this transitional period, the legal framework will change, affecting all involved parties. To address this, during November 2020, the MHRA provided several documents that serve as guidelines to help affected parties, especially Marketing Authorization Holders (MAH) in the whole UK,…

Safety Data Exchange Agreement

Safety Data Exchange Agreement (SDEA)

A Safety Data Exchange Agreement (SDEA) is a legal written contractual agreement between two or more parties that ensures that all necessary information on the safety of medicine reaches the marketing authorization holder (MAH) quickly and safely so that he can fulfill his legal obligations on time. It defines each party’s responsibilities in pharmacovigilance activities,…