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.
For More information please click here: EMA News: European Medicines Agency provides update on electronic submission of information on medicines
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