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
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
- 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
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