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


Article 57 fact sheet

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Document(s) Language Status First published Last updated Effective Date
Electronic submission of medicinal product information by marketing-authorisation holders BG = bălgarski   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders ES = español   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders CS = čeština   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders DA = dansk   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders DE = Deutsch   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders ET = eesti keel   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders EL = elliniká   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders EN = English   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders FR = français   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders IT = italiano   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders LV = latviešu valoda   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders LT = lietuvių kalba   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders HU = magyar   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders MT = Malti   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders NL = Nederlands   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders PL = polski   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders PT = português   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders RO = română   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders SK = slovenčina   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders SL = slovenščina   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders FI = suomi   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders SV = svenska   2014-12-17 2016-02-11  
Electronic submission of medicinal product information by marketing-authorisation holders HR = Hrvatski   2014-12-17 2016-02-11  

Outlines on Article 57(2) of Regulation (EU) 726/2004

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Document(s) Language Status First published Last updated Effective Date
Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004 (English only)   2015-02-17 2015-02-23  

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)   2011-07-01 2016-02-11 2014-06-16

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)   2011-09-01 2012-03-05  
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)   2011-09-01 2012-03-05  
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)   2011-09-01 2012-03-05  
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)   2012-03-05 2015-01-08 2014-06-16
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)   2012-03-05 2016-02-11 2015-05-01
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)   2012-03-05 2014-06-16  
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)   2011-09-01 2012-03-05  
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)   2011-09-01 2015-10-16 2015-10-15
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)   2011-09-01 2012-09-24  

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)   2012-03-05    
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)   2012-03-05    
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)   2012-03-05    
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)   2012-03-05 2015-01-08 2014-06-16
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)   2012-03-05 2016-02-11 2015-05-01
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)   2012-03-05 2014-06-16  
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)   2012-03-05    
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)   2012-03-05 2015-10-16 2015-10-15
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)   2012-03-05    

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)   2012-03-05 2014-01-17  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) authorisation procedures (English only)   2012-03-05 2014-01-17  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Authorisation status (English only)   2012-03-05 2014-04-29 2014-06-16
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) concentration types (English only)   2012-03-05 2014-01-17  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) medical devices (English only)   2012-03-05 2014-01-17  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (English only)   2012-03-05 2016-11-18  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (English only)   2012-03-05 2016-11-18  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) reference sources (English only)   2012-03-05 2014-01-17  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (English only)   2012-03-05 2016-11-18  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substance classes (English only)   2012-03-05 2014-01-17  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (English only)   2012-03-05 2016-11-18  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of measurement (English only)   2012-03-05 2014-01-17  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of presentation (English only)   2012-03-05 2015-02-17  
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Legal basis (English only)   2014-01-31   2014-06-16
EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Medicinal product types (English only)   2014-01-31 2014-07-09 2014-06-16

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)   2012-03-05 2016-06-17