ГОСТ РИСО 11616—2014
Библиография
(1} ISO 1087-1:2000, Terminology work — Vocabulary — Part 1. Theory and application
(2)ISO 1087-2:2000. Terminology work — Vocabulary — Part 2: Computer applications1>
(3)ISO/IEC 2382-4:1999, Information technology — Vocabulary — Pari 4: Organization of data
(4)ISO 21090. Health informatics — Harmonized data types for Information Interchange
(5)ISO/HL7 279S1, Health Informatics — Common terminology services, release 1
(6)HL7 Core Principles
(7)ENV 1613:1995, Medical informatics — Messages for exchange of laboratory information
(8)ENV 12610:1997, Medical Informatics — Medicinal product identification
(9)ENV 13607:2000, Health informatics — Messages for the exchange of information on medicine prescripbons
(10) ICH M5 Guideline 2005: Data Elements and Standards for Drug Dictionaries
(11) GHTF/AH (PD1)/N2ER1:2009 GHTF Discussion Paper (m view ofpreparation of a Draft Guidance on UDI for Medical
Devices) Title: Unique Device Identification (UDI) System
(12) The Food and Drugs Act and Regulations and related Health Canada Guidelines
(13) The Natural Health Product Regulations and related Health Canada Guidelines
(14) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code
relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and
Directive 2004/27/EC
(15) The requirements to be fulfilled in the member stales 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
(16) oGuidelme on the categorisation on New applications versus Variations* The Rules governing Medicinal Products
in the European Union. Notice to Applicants, Volume 2A and Volume 2C
(17) A Guideline on Summaryof Product Characteristics. December 1999 (Doc. Ref. Notice to Applicants, Final revision 0)
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/spcguidrev1
-oct2005.pdf
(18) Directive 2001/20/EC of the European Parliamentand ofthe Councilof 4 April 2001 on the approximation ofthe laws,
regulations and administrative provisions ofthe Member States relating to the implementation of good clinicalpractice
in the conduct of clinical trials on medicinal products for human use
(19) Commission Directive2003/63/EC of25June 2003amending Directive 2001/83/EC oftheEuropean Parliamentand of
the Council on the Community code relating to medicinal products for human use
(20) Regulation(EC) No 726/2004 of the European Parliament and oftheCouncilof 31 March 2004 layingdown Community
procedures forthe authorization and supervision ofmedicinal products forhuman and veterinary use and establishing a
European Medicines Authority
(21) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced
therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
(22) Commission Directive 2003/94/EC of8October 2003 laying down the principles and guidelinesofgood manufacturing
practice in respect of medicinal products for human use and investigational medicinal products for human use
(23) Guidelines on Pharmacovigilancefor Medicinal Productsfor Human Use. Volume9A ofthe Rules Governing Medicinal
Products m the European Union
(24) Guideline on declaration ofherbal substances and herbal preparations in herbal medicinal products/traditional herbal
medicinal products In the SPC. 26 July 2007 (Doc. Ref. ЕМЕА/НМРС/ CHMP/CVMP/287539/2005)
(25) Guideline on adjuvants in vaccines for human use. 20 January 2005 (Doc. Ref. ЕМЕА/СНМР/ VEG/134716/2004)
(26) Guideline on Similar Biological Medicinal Products. 30 October 2005 (Doc. Ref. CHMP/437/04)
(27) Guideline on Pharmaceutical Aspects of the Product Information for Human Vaccines, 26 November 2003 (Doc.
Ref. EMEA/CPMP/BWP/2758/02)
(28) Guideline on the acceptability of names for human medicinal products processed through the centralised procedure.
11 December 2007 (Doc. Ref. CPMP/328/98. Revision 5)
(29) Guideline on the Chemistry of new Active Substances. 17 December 2003 (Doc. Ref. CPMP/QWP/130/96 Rev. 1)
(30) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) Clinical Safety
(31) El The Extent of Population Exposure to Ass ess Clinical Safety for Drugs Intended for Long-Term Treatment of
Non-Life Threatening Conditions
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