European Medicines Agency provides update on electronic submission of information on medicines

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01/09/2011

European Medicines Agency provides update on electronic submission of information on medicines

The European Medicines Agency has updated the detailed guidance on the electronic submission of information on human medicines to include the XML Schema Definition (XSD). It has also published a set of controlled vocabularies to support the submission process.

Marketing-authorisation holders can now submit XSD-compliant product information on all the medicines authorised or registered in the European Union (EU) using tools developed in-house by pharmaceutical companies or software vendors via the EudraVigilance Gateway.

The detailed guidance is now structured as five separate chapters and annexes on the new page documents for electronic submission of information on medicines. This page also includes controlled vocabularies, XSD schema files and naming conventions. The Agency will add other documents to this page as they become available.

Today's update is the second stage in the implementation of the new pharmacovigilance legislation (Regulation (EC) No. 726/2004) and follows the publication of the initial format for submission of information on medicines in July 2011. The submission process is in accordance with Article 57(2), second subparagraph of this Regulation.

The Agency is organising a workshop on 20 September 2011 with European pharmaceutical industry associations to discuss the practical questions on the implementation of the submission process. The Agency is also hosting two information days on 22 and 23 September 2011.

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