EXtended EudraVigilance Medicinal Product Dictionary .
eXtended EudraVigilance Medicinal Product Dictionary(XEVMPD) Data-Entry Tool (EVWEB) user manualVersion 5.5Temporary visiting address Spark building Orlyplein 24 1043 DP Amsterdam The NetherlandsFor deliveries refer to www.ema.europa.eu/how-to-find-usSend us a question via www.ema.europa.eu/contacts Telephone 31(0)88 781 6000An agency of the European Union European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
Summary of changesThe below sections were amended following the publication of version 5.4 in December 2016. Thechanges are highlighted in red. New sections are marked as 'NEW': 1.7.1.2. SponsorsEditorial changes in this document are not included in the summary of changes.The below sections have been amended: Section 2.1.1 Updated EVWEB services menu Added screenshot of select organizationeXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool(EVWEB) user manualEMA/308954/2012Page 1/186
Table of ContentSummary of changes . 11. INTRODUCTION . 61.1. About this User Manual . 61.2. About EudraVigilance . 71.3. EudraVigilance system overview . 81.4. EudraVigilance ESTRI gateway . 81.5. EVWEB . 91.6. eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) . 101.7. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) . 121.7.1. Data submission in the XEVMPD . 151.7.1.1. Marketing authorisation holders (MAHs) . 151.7.1.2. Sponsors . 161.7.2. Data collected in the XEVMPD . 191.7.2.1. Authorised medicinal product (AMP) . 211.7.2.2. Development medicinal product (DMP) . 221.7.2.3. Approved substance (AS) . 231.7.2.4. Development substance (DS) . 241.7.2.5. Source . 241.7.2.6. MAH organisation . 241.7.2.7. Sponsor organisation. 251.7.2.8. Development/proposed ATC Code . 251.7.2.9. Development/proposed pharmaceutical form . 261.7.2.10. Development/proposed route of administration . 261.7.2.11. Printed product information (PPI)/printed substance information (PSI) . 261.7.2.12. Pharmacovigilance System Master File Location (PSMFL) . 271.7.3. XEVMPD terminologies . 281.7.4. Data ownership and maintenance . 281.7.5. Data quality . 291.7.6. Product status fields. 291.7.7. Data access policy . 321.7.8. Controlled vocabularies and terminologies . 332. EVWEB . 352.1. Accessing EVWEB . 352.2. The main menu . 372.2.1. Sections navigator menu . 372.2.2. Default buttons set . 382.2.3. Dynamic buttons set . 392.3. The tree view . 392.4. The active area . 412.5. Interaction between the tree view and active area . 43eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool(EVWEB) user manualEMA/308954/2012Page 2/186
2.6. Data entry . 442.6.1. Input field types . 442.6.1.1. Text field . 452.6.1.2. Date/time field . 472.6.1.3. Look-up fields (or Look-up tables) . 482.6.1.4. Query fields (Remote database lookup tables) . 492.6.1.5. Query fields (Local data lookup tables) . 532.6.2. Adding and removing items . 542.6.3. Checklists . 572.6.4. Select/Deselect checklist . 582.6.5. Load/Delete checklist . 592.6.6. Add/Delete checklist . 602.7. Search methods . 622.7.1. Simple query . 622.7.2. Advanced Query . 642.7.2.1. Fields section . 652.7.2.2. Conditions (AND) section . 672.7.2.3. Results section . 682.7.3. Immediate Query . 722.8. Loading data . 732.8.1. Load from the EVDBMS . 732.8.1.1. Load/Delete checklist . 732.8.1.2. Select/Deselect checklist . 742.8.2. Load from a remote file . 752.8.3. Load from a local file . 762.8.4. Load from inside the EVWEB . 772.9. Pop-up Commands . 782.10. Batch Commands . 792.10.1. XEVMPD Bulk Update Manager tool . 802.10.2. Create an XEVPRM with various commands – practical example . 812.11. WEB Trader Functions (Inbox/Outbox/Imported Messages) . 832.11.1. Importing a Message from Web Trader folders . 872.11.1.1. Importing a Message created using Bulk Update Manager tool . 882.11.2. Importing a message from the local computer . 892.11.3. Reloading an XEVPRM. 892.12. Export functions and available formats . 902.12.1. Data-export functionality . 913. CREATE AND SEND XEVPRMs . 923.1. Commands/Operation types to be used in an XEVPRM . 923.2. Create an XEVPRM with operation type 'Insert (1)' . 933.2.1. Insert of an authorised medicinal product (AMP) . 953.2.1.1. How to reference information not yet present in the XEVMPD in your AMP entry . 973.2.2. Insert of a development medicinal product (DMP) . 993.2.2.1. Sender Local Code (DP.4) . 1003.2.2.2. Sponsor Code (DP.5) . 100eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool(EVWEB) user manualEMA/308954/2012Page 3/186
3.2.2.3. Product Code (DP.6.1) . 1013.2.2.4. Product Name (DP.6.2) . 1013.2.2.5. Product Other Name (DP.6.3) . 1013.2.2.6. Comment (DP.7) . 1013.2.2.7. How to reference information not yet present in the XEVMPD in your DMP entry . 1023.2.3. Insert of an approved substance. 1043.2.4. Insert of a development substance . 1063.2.5. Insert of a reference source . 1093.2.6. Insert of MAH organisation . 1103.2.7. Insert of Sponsor organisation . 1113.2.8. Insert of a proposed ATC Code . 1123.2.9. Inset of a development ATC Code . 1143.2.10. Insert of a proposed pharmaceutical form . 1153.2.11. Insert of a development pharmaceutical form . 1163.2.12. Insert of a proposed route of administration . 1173.2.13. Insert of a development route of administration . 1183.2.14. Insert of an attachment . 1193.2.14.1. Insert of Printed Product Information (PPI) . 1203.2.14.2. Insert of Printed Substance Information (PSI) . 1243.2.15. Insert of a Master File Location . 1273.2.15.1. How to reference a Master File Location entity in an AMP entry - operation type'Insert (1)' . 1283.2.15.2. How to reference a Master File Location entity in an AMP entry - operation type'Update (2)'. 1303.3. Duplicate an entity in an XEVPRM . 1303.4. Create an XEVPRM with maintenance related operation types/commands . 1323.4.1. Update of entities in the XEVMPD . 1323.4.1.1. Create an XEVPRM with operation type 'Update (2)' . 1323.4.2. Variation of a medicinal product in the XEVMPD . 1343.4.3. Nullification of an entity in the XEVMPD . 1343.4.3.1. Create an XEVPRM with operation type 'Nullification (4)' . 1353.4.4. Revocation/Withdrawal/Expiry of product entity in the XEVMPD . 1373.4.4.1. Create a Product Report with Operation Type 'Invalidate MA (6)' . 1383.4.5. Transfer of marketing authorisation of a product entity . 1403.5. Validation of an XEVPRM . 1403.6. Save, Reload and Send an XEVPRM . 1423.7. How to Use EV Post . 1424. XEVMPD . 1454.1. Accessing XEVMPD . 1454.2. Simple queries in the XEVMPD . 1464.2.1. Exporting results of a simple query . 1484.3. Advanced Queries in XEVMPD . 1494.3.1. Exporting results of an advanced query . 1534.4. Export of owned entities to an Excel spread sheet . 1584.4.1. Exporting an overview of all owned entities to an Excel spread sheet . 158eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool(EVWEB) user manualEMA/308954/2012Page 4/186
4.4.2. Exporting an overview of all owned AMP entities to an Excel spread sheet . 1594.5. Displaying/printing and saving information from XEVMPD . 1604.6. Retrieving previous version(s) of medicinal product entity . 1614.7. Retrieving 'Valid' versions of medicinal product entities . 1634.8. Comparing individual versions of a medicinal product entity. 1655. MedDRA . 1685.1. Introduction. 1685.2. MedDRA Structure . 1695.3. MedDRA in EVWEB . 1705.4. How to perform a Simple query . 1755.5. How to perform an Advanced Query . 1785.6. Current status for LLT . 1836. List of Abbreviations and Acronyms . 184eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool(EVWEB) user manualEMA/308954/2012Page 5/186
1. INTRODUCTION1.1. About this User ManualThis user manual is part of the official documentation prepared by the European Medicines Agency tosupport marketing authorisation holders (MAHs) and sponsors of clinical trials using the eXtendedEudraVigilance Medicinal Product Dictionary data-entry tool (EVWEB), and focuses on EVWEBfunctionalities based on the XEVPRM format published by the Agency on 31 January 2014 andavailable in the EVWEB production environment as of 16 June 2014.For marketing authorisation holders, related documents to be read in conjunction with this usermanual include: Chapter 3.II: XEVPRM User Guidance; Legal Notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004; Electronic submission of Article 57(2) data: Questions & Answers (Q&As) document.Further information related to the electronic submission of authorised medicines can be found on theReporting requirements for marketing-authorisation holders webpage of the Agency's website.Case and medicinal product examples used in this manual to describe the functionalities andrules of the system are fictitious and are intended for demonstration purposes only.eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool(EVWEB) user manualEMA/308954/2012Page 6/186
1.2. About EudraVigilanceEudraVigilance is the European Union pharmacovigilance database and data-processing network (the'EudraVigilance database'). It supports the: secure exchange, processing and evaluation of Individual case safety reports (ICSRs) related tomedicinal products authorised in the European Union (EU) and investigational medicinal products(IMPs) studied in clinical trials authorised in the EU; signal detection, evaluation and management; proactive release of information on adverse reactions in compliance with personal data protectionlegislation in the EU; electronic submission of information of medicinal products authorised in the EU; provision of information on IMPs by the sponsor before completing a clinical trials application in theEU.Main components are: EudraVigilance (EV) gateway: a data-processing network for the secure electronic exchange ofadverse reaction data; EudraVigilance Post-Authorisation Module (EVPM):dedicated to the collection of ICSRsrelated to all medicinal products authorised in the EEA in line with Regulation (EC) No 726/2004and Directive 2001/83/EC; EudraVigilance Clinical Trial Module (EVCTM): dedicated to the collection of ICSRs ofSuspected Unexpected Serious Adverse
Legal Notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004; Electronic submission of Article 57(2) data: Questions & Answers (Q&As) document. Further information related to the electronic submission of authorised medicines can be found on the
EudraVigilance - EVWEB User Manual EMA/501718/2018 Page 5/103 1. Introduction 1.1. About this User Manual This user manual is part of the official documentation prepared by the European Medicines Agency (EMA) to support the use of the EudraVigilance Web reporting tool EVWEB.
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clinical trials and the WHO Uppsala Monitoring Centre . The goal is to ensure sustainability of EudraVigilance and associated activities in support of the EU pharmacovigilance activities and the protection of public health. In addition, the interaction with stakeholders as part of training and support as well as communication
This go-live plan outlines a set of detailed, sequenced tasks and activities required to lau nch the new EudraVigilance production system including the migration of more than 11 million Individual Case Safety Reports (ICSRs) and associated data and the decommissioning of the current (legacy)
The Agency's Identity and Access Management (IAM2) project aims to simplify the registration and management of . EudraVigilance. organisations and users from a business process and technology point of view. As part of the project, the Eu draVigilance platform will be integrated with two
rules and validation steps as described in the 'Note for Guidance EudraVigilance Human - Processing of Safety Messages and Individual Case Safety Reports (ICSRs)' (Doc. Ref. EMA/H/20665/04/Final, Revision 1). The following aspects are outlined in detail: The mandatory electronic reporting essentials
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