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Transition plan from Article 57/XEVMPD data submission to SPOR

In the context of the implementation of the ISO IDMP standards, the European Medicines Agency (EMA) is establishing services to support the management of master data, i.e. substance, product, organisation and referential (collectively referred to as ‘SPOR’) data. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. The phased implementation plan envisages the prioritisation of the ‘Referentials’ and the ‘Organisation’ management services (RMS and OMS) in 2016 with the view of making them available in 2017. This document is a preliminary communication on the foreseen transition from the current Article 57 processes to the ‘to be’ SPOR processes. It is aimed at clarifying the change management plan for the provision of information related to the referential and organisation entities, currently managed via the eXtended EudraVigilance Product Report Message (XEVPRM) format, within the OMS and RMS requirements. This document also includes the process change for submissions of approved substance information to the Agency. The requirements will apply to the marketing authorisation holders (MAHs) and sponsors of clinical trials currently submitting data in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). The processes and technology for the EMA and the relevant stakeholders to enable the registration and maintenance of the master data are currently being established, and will be communicated to all stakeholders once available.

Source: European Medicines Agency

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