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EU: EMA Publishes Updated Q&As on New EudraVigilance System

Thursday, August 10, 2017: In further preparation for the launch of the New EudraVigilance System planned for 22nd November 2017, the European Medicines Agency (EMA) has published an extended and updated set of Q&As to help the transition to the new system.

Since the release of the original document in July, the EMA service desk have apparently received a flood of questions and queries by those affected by the launch. As a result, the Q&A document has nearly tripled in length in order to attempt to answer all of these incoming questions!

One key question now addressed is in regard to the service providers and CROs of MAHs and whether or not they will be able to gain access to the EVDAS system. In short, the answer is “No”! There are no plans grant access to service providers although they can be registered by the MAH as a third party acting on behalf of an organisation.

There are also nearly 40 new questions pertaining to the ICSR download manager and 26 for Module VI and IX of the GVP. These are all helpfully identified as ‘new’ (in red) in the various sections.

Queries relating to ‘going live’, testing procedures for electronic data interchange partners and even general technical questions are also tackled in this updated document.

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