ГОСТ РИСО 11616—2014
[32) Е2А Clinical Safety Data Management. Definitions and Standards for Expedited Reporting
[33) E28(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
[34) E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
[35) Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs (in E2C(R1)]
[36) E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
[37) E2E Pharmacovigltance Planning
[38) E2F Development Safety Update Report
[39) Standard Terms: Dosage Forms. Routes of Administration and Containers. EDOM. Fifth Edition. December 2004.
Version 5.0.0
[40) EudraVIgilance Medicinal Product Dictionary (EVMPD)Version 2.0 Techmcal Specifications. 9 November 2004 (Doc.
Ref. EMEA/140190/2004)
[41) EudraVIgilance Medicinal Product Dictionary (EVMPD) Version 2.0 Message and Acknowledgement Specifications.
8 December 2004 (Doc. Ref. EMEA/178966/2004)
[42) EudraVIgilance (EV) Access simple Database Version 2.0 8 November 2004 (Doc. Ref: ЕМЕАЛ40327/2004)
[43) EudraVIgilance (EV) Access Simple Database Version 2.0 Forms Documentation. 31 January 2005 (Doc. Ref:
EM EA/35416/2005)
[44) EudraVIgilance (EV) Access Simple Database Version 2.0 Step by Step Guide 8 December 2004 (Doc. Ref:
EMEA/191986/2004)
[45) Evropean Pharmacopeia (Ph. Eur.)
[46) Ministry of Health and Welfare. PSB/SD Notification No.37 (29th March 1999) (All documents are availabie only in
Japanese. Please note documents’ names are only tentative translation) Electronic package Insert information
accompanied by the Utility system of Information provision on drug safety
[47) Appendix: Electronic formatofpackage insertinformation on ethicaldrugs (SGMLVDTD Ver. 2.0)Appendlxl DTDVer.
2.0
[48) Appendix2 Overview of SGML creation
[49) Appendix3 DCL Appendix4 Template of SGML
[50) Appendix5 Data model (Entitles and relationships)
[51) Appendix6 List of fields of package insert Information
[52) Japanese Pharmacopoeia (Fifteenth Edition in English to be published) ‘the Japanese Pharmacopoeia Fourteenth
Edition
[53) *the Japanese Pharmacopoeia Fourteenth Edition, supplement 1
[54) ‘the Japanese Pharmacopoeia Fourteenth Edition, supplement II
[55) United States Pharmacopoeia (USP)
[56) United States Department of Agriculture’s (USDA) Integrated Taxonomic Information System (ITIS)
http://www.lt
is.usda.gov
[57) Guidance for Industry Providing Regulatory Submissions in Electronic Formal — Content of Labelling
[58) Release Notes for SPL Schema PORR_MT050020 (3.20.05)
[59) CaCore 2.0 Technical Guide. National Cancer Institute. Center for Bioinformatics. U.S. Department of Health and
Human Services
[60) A guide to RxNorm. United States National Library of Medicine, National Institute of Health
[61) Substance Registration System (SRS) SRS Substance Definition Manual Version 5b Final Draft.doc
[62) The Unified Code for Units of Measure
[63) The U.S. Consolidated Healthcare Informatics Initiative
[64) FDA 21 CFR 310.305
[65) V/HO Technical Report 498(1972). ICH E2A
[66) CDISC Clinical Research Glossary V8.0. 2009
[67) EC Directive 2007/47 on Medical Devices
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