ГОСТ РИСО 11238—2014
Библиография
[1] ISO 1087-1. Terminology work — Vocabulary — Pari 1: Theory and application
[2] ISO 1087-2. Terminology work — Vocabulary — Pad 2: Computer applications’-
[3]ISO 3166-1. Codes for the representationof names ofcountries and their subdivisions— Part 1. Country codes
[4]ISO 8601, Data elements and interchange formats — Information interchange —Representation of dates and
times
[5]ISO 11615. Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated medicinal product information
[6]ISO 11616. Health Informatics — Identification of medicinal products — Data elements and structures for the
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[7]ISO 11239. Health Informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated information on pnarmaceutical dose forms, units of presentation,
routes of administration and packaging
[8]ISO 11240. Health Informatics — Identification of medicinal products — Data elements and structures for the
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[9]ISO/IEC 2382-4. Information technology — Vocabulary — Part 4: Organization of data
(10J ISO/lEC 7064, Information technology — Security techniques — Check character systems
(11)ISO/HL7 27951. Health informatics — Common terminology services, release 1
(12) ISO/HL7 27953-1. Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1:
Framework for adverse event reporting
(13) ISO/HL7 27953-2. Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2:
Human pharmaceutical reporting requirements for ICSR
(14J HL7 Common Product Model. Substance Model (POCP MT080100) and Substance Specification Model
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(21) Resources related to FDA’s Substance Registration system
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(23)The Integrated Taxonomic Information System
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(25) The Natural Health Product Regulations and related Health Canada Guidelines:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php
(26) Directive 2001/83/EC of the European Parliament and ofthe 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
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code.pdf
(27) "Guideline on the categorisation on New applications versus Variations". The Rules governing Medicinal Products
in the European Union. Notice to Applicants. Volume 2C
(28) The Rules governing Medicinal Products in the European Union. Notice to Applicants. Volume 2A and Volume 2C
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(29) A Guideline on Summary of Product Characteristics. December 1999, (Doc. Ref. Notice to Applicants. Final —
revision 0)
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(30) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the
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clinical practice in the conduct of clinical trials on medicinal products for human use http//
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(31) Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament
and of the Council on the Community code relating to medicinal products for human use
http://ec.europa.eu/enterprlse/pharmaceuticals/eudralex/vol-1/dir
2003 63/dir 2003 63 en.pdf
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