European Medicines Agency’s Data Protection Notice for EudraVigilance Human (EV)

15 July 2022 — EMA published updated data protection notice for EudraVigilance Human.

This Data protection notice explains the most essential details of the processing of personal data in the context of the operation of EudraVigilance Human (EV) established in accordance with the requirements of Article 24(1) of Regulation (EU) No 726/2004. The European Medicines Agency (hereafter referred to as “the Agency”), in collaboration with Union Member States and the European Commission, has set up and maintains the EudraVigilance database and data processing network2 to collate and analyze information on suspected adverse reactions regarding investigational medicinal products (IMPs) studied in clinical trials and medicinal products authorized in the EU.

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