Documents for electronic submission of information on medicines

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This page lists the documents related to the electronic submission of information on medicines by marketing-authorisation holders.

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 05/03/2012  

Article 57(2) requirements: Frequently asked questions

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Document(s) Language Status First published Last updated Effective Date
Extended EudraVigilance medicinal product report message (XEVPRM): Frequently asked questions and answers (FAQs) (English only)   05/03/2012 28/02/2013  
Article 57(2) requirements: information to marketing authorisation holders on the updated format for electronic submission of information on medicines (English only)   05/03/2012    

Detailed guidance on electronic submission of information on medicinal products

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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 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)   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)   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: 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 04/02/2013  
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 04/02/2013  
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 04/02/2013  
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 04/02/2013  
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    
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    
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 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)   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)   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 6: Annex (English only)   01/09/2011 24/09/2012  
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 6: Annex (English only)   05/03/2012    

Controlled vocabularies

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Document(s) Language Status First published Last updated Effective Date
Extended EudraVigilance product report message (XEVMPD) Anatomical Therapeutic Chemical (ATC) code addition, version 1.0 (English only)   05/03/2012    
Extended EudraVigilance product report message (XEVMPD) authorisation procedures, version 1.0 (English only)   05/03/2012    
Extended EudraVigilance product report message (XEVMPD) authorisation status, version 1.0 (English only)   05/03/2012    
Extended EudraVigilance product report message (XEVMPD) concentration types, version 2.0 (English only)   05/03/2012 25/06/2012  
Extended EudraVigilance product report message (XEVMPD) medical devices (English only)   05/03/2012 27/03/2013  
Extended EudraVigilance product report message (XEVMPD) organisations (English only)   05/03/2012 29/05/2013  
Extended EudraVigilance product report message (XEVMPD) pharmaceutical dose forms, version 6.0 (English only)   05/03/2012 05/02/2013  
Extended EudraVigilance product report message (XEVMPD) reference sources, version 3.0 (English only)   05/03/2012 18/09/2012  
Extended EudraVigilance product report message (XEVMPD) routes of administration, version 1.0 (English only)   05/03/2012    
Extended EudraVigilance product report message (XEVMPD) substance classes, version 1.0 (English only)   05/03/2012    
Extended EudraVigilance product report message (XEVMPD) substances (English only)   05/03/2012 29/05/2013  
Extended EudraVigilance product report message (XEVMPD) units of measurement, version 10.0 (English only)   05/03/2012 05/02/2013  
Extended EudraVigilance product report message (XEVMPD) units of presentation, version 5.0 (English only)   05/03/2012 26/11/2012  

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