ГОСТ РИСО 11615—2014
Библиография
[1] EudraLex Volume 1 ‘Pharmaceutical Legislation Medicinal Products for Human Use"
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[2]GHTF/AH(PD1)/N2R1:2009. GHTF Discussion Paper (с учетом подготовки проекта руководства по данному
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[3]ENV 12610:1997. Medical Informatics — Medicinal product identification
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[5] The Natural Health Product Regulations and related Health Canada Guidelines:
http://www.hc-sc.gc.ca/hpfb-dgpsa/
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[6JDirective 2007/47/EC Of The European Parliament and of the Council of 5 September 2007amending Council
Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical
devices. Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of
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[7] The requirements to be fulfilled in the member states of the European Union by medicinal devices and of implantable
medicinal devices are respectively defined in Directive 93/42/EEC and Directive 90/385/EEC. http;//eur-lex.europa.
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[8]Guideline on declaration of herbal substances and herbal preparations in herbal Medicinal Products/traditional
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[11J Guideline on similar biological medicinal products containing monoclonal antibodies — non-clinical and clinical
issues. 30 May 2012 (Doc. Ref. EMA/CHMP/BMWP/403543/2010):
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[12] Guideline on Pharmaceutical Aspects of the Product Information for Human Vaccines, 26 November 2003 (Doc.
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[13] Guideline on the acceptability of names for human Medicinal Products processed through the centralized procedure. 11
December 2007 (Doc. Ref. CPMP/328/98. Revision 5)
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[14] Guideline on the Chemistry of new Active substances, 17 December 2003 (Doc. Ref. CPMP/QWP/130/96 Rev. 1)
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[15] The Rules Governing Medicinal Products in the European Union Volume 2C Notice to Applicants. A Guideline On
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[16] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) Clinical Safety
http://wvAv.ich.org
[17] ICH E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of
Non-Life Threatening Conditions
http://www.ich.org
[18] E2A Clinical Safety Data Management; Definitions and Standards for Expedited Reporting
http://www.ich.org
[19] E2B(R3) Clinical Safety Data Management; Data Elements for Transmission of Individual Case Safety Reports
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[20] E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
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[21] Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs [in E2C(R1 j]
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[22] Periodic Benefit-Risk Evaluation Report (PBRER),
http://ww4v.ich.org
[23] E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
http://www.ich.org
[24] E2E Pharmacovigilance Planning
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[25] E2F Development Safety Update Report
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[26] Standard Terms: Dosage Forms. Routes of Administration and Containers. EDQM.
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[27] European Pharmacopoeia (Ph.Eur.)
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[28] Ministry of Health and Welfare. PSB/SD Notification No.37 (29th March 1999) (Все документы доступны толь ко на
японском языке. Учтите, что название документов представляет собой только примерный перевод.)
Electronic package insert information accompanied by the Utility system of Information provision on dnjg safety
https://skw.info.pmda.go.jp’notice/nt990329.pdf
[29] Appendix: Electronic format of package insert information on ethical drugs (SGML/DTD Ver2.0) Appendixl DTD
Ver.2.0
https://skw.info.pmda.go.jp/notice/nt990329dtd.zip
[30] Appendix2 Overview of SGML creation
https://skw.info.pmda.go.jp/notice/nt990329ol.pdf
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