Guidance documents

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This page lists documents related to data submission for authorised medicines, including the legal notice, detailed guidance documents and controlled vocabularies for the Extended EudraVigilance Product Report Message (XEVPRM) schema.

Table of contents


Legal notice

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Document(s) Language Status First published Last updated Effective Date
Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 (English only)   01/07/2011 31/01/2014 16/06/2014

Detailed guidance: PDF format

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Document(s) Language Status First published Last updated Effective Date
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 1: Introduction (English only)   01/09/2011 05/03/2012  
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 2: Electronic submission of information on medicinal products by marketing authorisation holders (English only)   01/09/2011 05/03/2012  
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3: Extended EudraVigilance product report message (XEVPRM) technical specifications, user guidance and practical examples (English only)   01/09/2011 05/03/2012  
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No 726/2004: Chapter 3.I: Extended EudraVigilance product report message (XEVPRM) technical specifications (English only)   05/03/2012 07/04/2014 16/06/2014
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance (English only)   05/03/2012 09/07/2014 16/06/2014
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.III: Practical examples (English only)   05/03/2012 16/06/2014  
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 4: Structured substance information (English only)   01/09/2011 05/03/2012  
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 5: Extended EudraVigilance product report acknowledgement message (English only)   01/09/2011 07/04/2014 16/06/2014
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 6: Annex (English only)   01/09/2011 24/09/2012  

Detailed guidance: Word format

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Document(s) Language Status First published Last updated Effective Date
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 1: Introduction (English only)   05/03/2012    
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 2: Electronic submission of information on medicinal products by marketing authorisation holders (English only)   05/03/2012    
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3: Extended EudraVigilance product report message (XEVPRM) technical specifications, user guidance and practical examples (English only)   05/03/2012    
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No 726/2004: Chapter 3.I: Extended EudraVigilance product report message (XEVPRM) technical specifications (English only)   05/03/2012 07/04/2014 16/06/2014
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance (English only)   05/03/2012 09/07/2014 16/06/2014
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.III: Practical examples (English only)   05/03/2012 16/06/2014  
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 4: Structured substance information (English only)   05/03/2012    
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 5: Extended EudraVigilance product report acknowledgement message (English only)   05/03/2012 07/04/2014 16/06/2014
Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 6: Annex (English only)   05/03/2012    

Data quality-control methodology

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Controlled vocabularies

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Document(s) Language Status First published Last updated Effective Date
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) Anatomical Therapeutic Chemical (ATC) code addition (English only)   05/03/2012 17/01/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) authorisation procedures (English only)   05/03/2012 17/01/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Authorisation status (English only)   05/03/2012 29/04/2014 16/06/2014
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) concentration types (English only)   05/03/2012 17/01/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) medical devices (English only)   05/03/2012 17/01/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (English only)   05/03/2012 04/06/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (English only)   05/03/2012 04/06/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) reference sources (English only)   05/03/2012 17/01/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (English only)   05/03/2012 04/06/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substance classes (English only)   05/03/2012 17/01/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (English only)   05/03/2012 04/06/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of measurement (English only)   05/03/2012 17/01/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of presentation (English only)   05/03/2012 17/01/2014  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Legal basis (English only)   31/01/2014   16/06/2014
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Medicinal product types (English only)   31/01/2014 09/07/2014 16/06/2014

Controlled vocabularies: quality control

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Frequently asked questions

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Document(s) Language Status First published Last updated Effective Date
Electronic submission of Article 57(2) data: questions and answers (English only)   05/03/2012 09/07/2014