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

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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

Legal notice

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

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

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

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

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

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

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

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

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

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

EudraVigilance eXtended medicinal product dictionary acknowledgement codes

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

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

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

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

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

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

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

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

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

Data quality-control methodology

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

Measures for Article 57 data quality assurance

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

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

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)

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

Controlled vocabularies

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

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) authorisation procedures

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Authorisation status

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) concentration types

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) medical devices

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) reference sources

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substance classes

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of measurement

EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) legal basis

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

Controlled vocabularies: quality control

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

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

Frequently asked questions

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

Communication to marketing authorisation holders

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

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