EudraVigilance Update Needs 10-Day IT Shutdown At EMA; Interim ADR Reporting Plans In Place
Executive Summary
The European Medicines Agency is having to shut down some of its systems for two weeks in order to have the revamped EU pharmacovigilance database up and running for 9am on Nov. 22. The shutdown will affect the reporting of adverse drug reactions as well as some aspects of other processes such as submission of periodic safety reports and marketing authorization applications. Companies will have to be vigilant as arrangements will vary from country to country.