Guidance documents
Table of contents
- Article 57 fact sheet
- Outlines on Article 57(2) of Regulation (EU) 726/2004
- Legal notice
- Detailed guidance: PDF format
- Detailed guidance: Word format
- Data quality-control methodology
- Controlled vocabularies
- Controlled vocabularies: quality control
- Frequently asked questions
- Communication to marketing authorisation holders
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.
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Chapter 1: Introduction of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (PDF/154.74 KB)
First published: 01/09/2011
Last updated: 05/03/2012
EMA/717178/2011 -
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Chapter 2: Electronic submission of information on medicinal products by MAH of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (PDF/135.73 KB)
First published: 01/09/2011
Last updated: 07/08/2018
EMA/717179/2011 -
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Chapter 3: XEVPRM technical specifications, user guidance and practical examples of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (PDF/137.29 KB)
First published: 01/09/2011
Last updated: 05/03/2012
EMA/721644/2011 -
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Chapter 3.I: Technical specifications of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (PDF/2.97 MB)
First published: 05/03/2012
Last updated: 25/07/2019
Legal effective date: 25/07/2019
EMA/101344/2012 -
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Chapter 3.II: XEVPRM user guidance of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (PDF/2.26 MB)
First published: 05/03/2012
Last updated: 14/09/2021
Legal effective date: 13/09/2021
EMA/135580/2012 Version 3.14 -
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Chapter 3.III: Practical examples of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (PDF/631.12 KB)
First published: 05/03/2012
Last updated: 16/06/2014
EMA/140557/2012 version 4.0 -
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Chapter 4: Structured Substance Information (currently not applicable) of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (PDF/108.35 KB)
First published: 01/09/2011
Last updated: 05/03/2012
EMA/721630/2011 -
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Chapter 5: eXtended EudraVigilance Product Report Acknowledgement Message of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (PDF/473.74 KB)
First published: 01/09/2011
Last updated: 16/10/2015
Legal effective date: 15/10/2015
EMA/718844/2011 Version 3.4 -
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Chapter 6: Definitions of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (PDF/133.32 KB)
First published: 01/09/2011
Last updated: 24/09/2012
EMA/720203/2011 -
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EudraVigilance eXtended medicinal product dictionary acknowledgement codes (XLS/126.5 KB)
First published: 08/01/2015
Last updated: 25/07/2019
EMA/792575/2014
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Chapter 1: Introduction of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (DOC/556 KB)
First published: 05/03/2012
Last updated: 05/03/2012
EMA/717178/2011 -
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Chapter 2: Electronic submission of information on medicinal products by MAH of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (DOC/202 KB)
First published: 05/03/2012
Last updated: 07/08/2018
EMA/717179/2011 -
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Chapter 3: XEVPRM technical specifications, user guidance and practical examples of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (DOC/397.5 KB)
First published: 05/03/2012
Last updated: 05/03/2012
EMA/140556/2012 -
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Chapter 3.I: Technical specifications of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (DOC/4.56 MB)
First published: 05/03/2012
Last updated: 25/07/2019
Legal effective date: 25/07/2019
EMA/101344/2012 -
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Chapter 3.II: XEVPRM user guidance of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (DOC/7.18 MB)
First published: 05/03/2012
Last updated: 14/09/2021
Legal effective date: 13/09/2021
EMA/135580/2012 Version 3.14 -
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Chapter 3.III: Practical examples of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (DOC/1.36 MB)
First published: 05/03/2012
Last updated: 16/06/2014
EMA/140557/2012 version 4.0 -
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Chapter 4: Structured Substance Information (currently not applicable) of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (DOC/136.5 KB)
First published: 05/03/2012
Last updated: 05/03/2012
EMA/721630/2011 -
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Chapter 5: eXtended EudraVigilance Product Report Acknowledgement Message of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (DOC/969 KB)
First published: 05/03/2012
Last updated: 16/10/2015
Legal effective date: 15/10/2015
EMA/718844/2011 Version 3.4 -
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Chapter 6: Definitions of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA (DOC/200 KB)
First published: 05/03/2012
Last updated: 05/03/2012
EMA/720203/2011
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Coding of indications in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) (PDF/1.33 MB)
First published: 01/12/2015
Last updated: 01/12/2015
EMA/245789/2015 -
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Measures for Article 57 data quality assurance (PDF/679 KB)
First published: 15/10/2015
Last updated: 15/10/2015
EMA/465609/2015 -
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Quality control of medicinal-product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No. 726/2004 (PDF/239.57 KB)
First published: 19/11/2014
Last updated: 20/01/2016
EMA/661709/2014 Rev. 6 -
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European Medicines Agency substance names best practice: Procedure and principles to handle substance name in the substance management system (PDF/547.12 KB)
First published: 16/06/2014
Last updated: 10/04/2018
EMA/40951/2014 -
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European Medicines Agency splitting of the full presentation name of the medicinal product best practice: procedure and principles to handle product name in the EudraVigilance Medicinal Product Dictionary (XEVMPD) (PDF/372.61 KB)
First published: 16/06/2014
Last updated: 25/01/2016
EMA/327516/2014 Rev. 3 -
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Data quality control methodology for data submitted under Article 57(2) of Regulation (EC) No.726/2004 (PDF/284.74 KB)
First published: 15/04/2014
Last updated: 10/04/2018
EMA/227883/2014
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) Anatomical Therapeutic Chemical (ATC) code addition (XLS/108 KB)
First published: 05/03/2012
Last updated: 17/01/2014
EMA/136151/2012 Rev. 1 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) authorisation procedures (XLS/96 KB)
First published: 05/03/2012
Last updated: 14/09/2021
Legal effective date: 13/09/2021
EMA/136152/2012 Rev. 2 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Authorisation status (XLS/110 KB)
First published: 05/03/2012
Last updated: 29/04/2014
Legal effective date: 16/06/2014
EMA/136153/2012 Rev.3 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) concentration types (XLS/116.5 KB)
First published: 05/03/2012
Last updated: 17/01/2014
EMA/136154/2012 Rev. 2 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) medical devices (XLS/107.5 KB)
First published: 05/03/2012
Last updated: 17/01/2014
EMA/136155/2012 Rev. 2 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (XLS/1.59 MB)
First published: 05/03/2012
Last updated: 23/01/2023
EMA/136156/2012 Rev. 64 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (XLSX/131.99 KB)
First published: 05/03/2012
Last updated: 18/11/2022
EMA/136157/2012 Rev. 32 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) reference sources (XLS/129.5 KB)
First published: 05/03/2012
Last updated: 17/01/2014
EMA/136145/2012 Rev. 3 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (XLS/131 KB)
First published: 05/03/2012
Last updated: 18/11/2022
EMA/136146/2012 Rev.22 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substance classes (XLS/109 KB)
First published: 05/03/2012
Last updated: 17/01/2014
EMA/136147/2012 Rev. 1 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (XLSX/9.16 MB)
First published: 05/03/2012
Last updated: 23/01/2023
EMA/136148/2012 Rev. 64 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of measurement (XLS/124.5 KB)
First published: 05/03/2012
Last updated: 21/01/2019
EMA/136149/2012 Rev. 12 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of presentation (XLS/111.5 KB)
First published: 05/03/2012
Last updated: 17/02/2015
EMA/136150/2012 Rev. 7 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) legal basis (XLSX/94.53 KB)
First published: 31/01/2014
Last updated: 14/09/2021
Legal effective date: 13/09/2021
EMA/59699/2014 Rev.1 -
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EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Medicinal product types (XLS/109.5 KB)
First published: 31/01/2014
Last updated: 09/07/2014
Legal effective date: 16/06/2014
EMA/59709/2014 Rev.1
- Medical Dictionary for Regulatory Activities (MedDRA)
- Anatomical Therapeutic Chemical (ATC) classification system maintained by the World Health Organization Collaborating Centre for Drug Statistics Methodology
- Pharmaceutical forms and routes of administration standard terms maintained by the European Directorate for the Quality of Medicines and Healthcare
- Unified Code for Units of Measure (UCUM) maintained by the Regenstrief Institute
- Official list of ISO 3166-1 country codes maintained by the International Organization for Standardization (ISO)
- Official list of ISO 639-1:2002 codes for the representation of names of languages, part 1: Alpha-2 code maintained by the International Organization for Standardization (ISO)
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Cover note on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) substance controlled vocabulary following the quality control exercise (PDF/193.49 KB)
First published: 05/03/2014
Last updated: 12/04/2018
EMA/93253/2014 -
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Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Submission of substance information (PDF/297.33 KB)
First published: 07/11/2013
Last updated: 04/11/2019
EMA/254278/2014 Rev.3.1