EMA EudraVigilance Registration Manual

On September 25, 2019 EMA issued EMA EurdaVigilance Registration Manual.

To set-up a new organization in EudraVigilance, a series of steps need to be followed: 1) A person within the organization needs to be chosen as being responsible for managing the organization and its users in the EudraVigilance system. If the organization is a marketing authorization holder the primary responsible person will be a Qualified Person for Pharmacovigilance (QPPV); 2) Register for an EMA user account in the EMA Account Management portal if you do not already have one; 3) Check Organization Management System (OMS): if your organization is not present in OMS it will need to be registered; 4) Submit request to be registered as the responsible person for the organization; 5) Complete organization registration details in the EudraVigilance restricted area; 6) Set up the transmission mode; 7) Raise Service desk ticket to set up gateway connection or a webtrader connection

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