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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,…

LPPV strategy

Local Person for Pharmacovigilance (LPPV) Strategy Considerations in the European Union

To ensure the safety of their products Marketing Authorization Holders (MAHs) must have well-developed pharmacovigilance (PV) system in place. The launch of the PV system in the European Union (EU) requires the designation of the EU-QPPV, a person responsible for establishing and maintaining the PV system. In addition to the EU-QPPV, part of the National Competent Authorities (NCAs) of the EU member states require MAHs to appoint a local contact person for PV issues at the national level (local…

Documents with marks

Requirements for nomination of a PV contact person at national level

Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders (MAH) must have an appropriate and qualified person responsible for pharmacovigilance (EU-QPPV) domiciled or located within the European Union. Also, the EU pharmacovigilance framework establishes the opportunity for the National Competent Authorities (NCA) of the EU to request the nomination of a contact person for pharmacovigilance (PV) issues at a national level.   Such individuals are typically…