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I.S. EN ISO 11238:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012)
Available format(s)

Hardcopy , PDF

Superseded date

07-23-2013

Language(s)

English

Published date

01-01-2012

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Terms, definitions, symbols and abbreviated terms
3 Requirements
Annex A (informative) - Existing identifiers and
        molecular structure representations
Bibliography

Gives an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics.

DocumentType
Standard
Pages
55
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
EN ISO 11238:2012 Identical
ISO 11238:2012 Identical

ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
ISO 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO/HL7 27953-2:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
ISO/HL7 27951:2009 Health informatics Common terminology services, release 1
ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
ISO/IEC 2382-4:1999 Information technology Vocabulary Part 4: Organization of data
ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions Part 1: Country codes
ISO/IEC 7064:2003 Information technology Security techniques Check character systems
ISO/HL7 27953-1:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1: Framework for adverse event reporting
ISO 1087-2:2000 Terminology work Vocabulary Part 2: Computer applications
ISO 11239:2012 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

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