Guidance documents related to data submission for authorised medicines

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.

Article 57 fact sheet

Electronic submission of medicinal product information by marketing-authorisation holders

Reference Number: EMA/736031/2014 Rev. 1Summary:

Article 57 (2) of Regulation (EC) No 726/2004

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

Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004

Reference Number: EMA/471367/2014 Rev. 1Summary:

Outlines on Article 57(2) of Regulation (EU) No 1235/2010

Legal notice

Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004

Legal effective date: 16/06/2014Reference Number: EMA/505633/2011 Rev. 2

Detailed guidance: PDF format

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

Reference Number: EMA/717178/2011

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

Reference Number: EMA/717179/2011

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

Reference Number: EMA/721644/2011

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

Legal effective date: 25/07/2019Reference Number: EMA/101344/2012

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

Legal effective date: 13/09/2021Reference Number: EMA/135580/2012 Version 3.16

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

Reference Number: EMA/140557/2012 version 4.0

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

Reference Number: EMA/721630/2011

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

Legal effective date: 15/10/2015Reference Number: EMA/718844/2011 Version 3.4

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

Reference Number: EMA/720203/2011

EudraVigilance eXtended medicinal product dictionary acknowledgement codes

Reference Number: EMA/792575/2014

• Extended EudraVigilance product report message (XEVPRM) schema
• Extended EudraVigilance product report message-structured substance information (XEVPRM_SSI) schema

Detailed guidance: Word format

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

Reference Number: EMA/717178/2011

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

Reference Number: EMA/717179/2011

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

Reference Number: EMA/140556/2012

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

Legal effective date: 25/07/2019Reference Number: EMA/101344/2012

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

Legal effective date: 13/09/2021Reference Number: EMA/135580/2012 Version 3.15

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

Reference Number: EMA/140557/2012 version 4.0

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

Reference Number: EMA/721630/2011

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

Legal effective date: 15/10/2015Reference Number: EMA/718844/2011 Version 3.4

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

Reference Number: EMA/720203/2011

Data quality-control methodology

Coding of indications in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

Reference Number: EMA/245789/2015

Measures for Article 57 data quality assurance

Reference Number: EMA/465609/2015

Quality control of medicinal-product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No. 726/2004

Reference Number: EMA/661709/2014 Rev. 6

European Medicines Agency substance names best practice: Procedure and principles to handle substance name in the substance management system

Reference Number: EMA/40951/2014Summary:

As part of the efforts to provide high quality of Article 57(2) data, one important activity is focusing on the quality assurance of substances in the Extended EudraVigilance medicinal Product Dictionary (XEVMPD), which is the key reference terminology required for the description of medicines. EMA received to date ~110.000 substance names including translations.

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)

Reference Number: EMA/327516/2014 Rev. 3Summary:

This document aims to provide guidance on the splitting of the Full Presentation Name of medicinal products in the context of Art.57 product submission and maintenance, and implements the paragraph 1.2.13. AMP - Presentation Name element structure (AP.13) of the 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.

Data quality control methodology for data submitted under Article 57(2) of Regulation (EC) No.726/2004

Reference Number: EMA/227883/2014

Controlled vocabularies

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) Anatomical Therapeutic Chemical (ATC) code addition

Reference Number: EMA/136151/2012 Rev. 1

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) authorisation procedures

Legal effective date: 13/09/2021Reference Number: EMA/136152/2012 Rev. 2

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Authorisation status

Legal effective date: 16/06/2014Reference Number: EMA/136153/2012 Rev.3

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) concentration types

Reference Number: EMA/136154/2012 Rev. 2

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) medical devices

Reference Number: EMA/136155/2012 Rev. 2

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations

Reference Number: EMA/136156/2012 Rev. 64

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms

Reference Number: EMA/136157/2012 Rev. 32

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) reference sources

Reference Number: EMA/136145/2012 Rev. 3

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration

Reference Number: EMA/136146/2012 Rev.22

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substance classes

Reference Number: EMA/136147/2012 Rev. 1

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances

Reference Number: EMA/136148/2012 Rev. 64

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of measurement

Reference Number: EMA/136149/2012 Rev. 12

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) legal basis

Legal effective date: 13/09/2021Reference Number: EMA/59699/2014 Rev.1

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Medicinal product types

Legal effective date: 16/06/2014Reference Number: 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)

Controlled vocabularies: quality control

Cover note on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) substance controlled vocabulary following the quality control exercise

Reference Number: EMA/93253/2014

Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Submission of substance information

Reference Number: EMA/254278/2014 Rev.3.1

Frequently asked questions

Electronic submission of Article 57(2) data: questions and answers

Reference Number: EMA/159776/2013 Version 1.12

Communication to marketing authorisation holders

New legal basis and authorisation procedure values available in the Article 57 database

Reference Number: EMA/501910/2021