I.S. EN ISO 11615:2017
Current
The latest, up-to-date edition.
HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO 11615:2017)
Hardcopy , PDF
English
01-01-2017
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, symbols, abbreviated terms
4 Message exchange format
5 Conformance terminology and context as
it relates to the ISO IDMP standards and
corresponding IDMP technical specifications
6 Concepts required for the unique
identification of Medicinal Products
7 Description of the information modelling
principles and practices
8 Identifying characteristics for authorised
Medicinal Products
9 Information for an authorised Medicinal
Product
10 Identifying characteristics for Investigational
Medicinal Products
11 Information for an Investigational Medicinal
Product
Annex A (normative) - Full model - Authorised Medicinal
Products detailed diagram
Annex B (normative) - Full model - Investigational
Medicinal Products detailed diagram
Bibliography
Describes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
| DocumentType |
Standard
|
| Pages |
98
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11615:2017 | Identical |
| EN ISO 11615:2017 | Identical |
| ISO 1087-1:2000 | Terminology work Vocabulary Part 1: Theory and application |
| ISO 639-1:2002 | Codes for the representation of names of languages — Part 1: Alpha-2 code |
| 2007/47/EC : 2007 COR 1 2015 | DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE) |
| ISO/TS 19844:2016 | Health informatics Identification of medicinal products Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances |
| ISO/IEC 15416:2016 | Automatic identification and data capture techniques — Bar code print quality test specification — Linear symbols |
| ISO/IEC TR 24720:2008 | Information technology Automatic identification and data capture techniques Guidelines for direct part marking (DPM) |
| ISO/HL7 27953-2:2011 | Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR |
| ISO 21090:2011 | Health informatics — Harmonized data types for information interchange |
| ISO 11240:2012 | Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement |
| ENV 13607:2000 | Health informatics - Messages for the exchange of information on medicine prescriptions |
| ISO 11238:2012 | Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances |
| 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 |
| ENV 12610:1997 | Medical informatics - Medicinal product identification |
| ISO/TS 20440:2016 | Health informatics — Identification of medicinal products — Implementation guide for ISO 11239 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 |
| ISO/IEC 11404:2007 | Information technology — General-Purpose Datatypes (GPD) |
| ISO 3166-1:2013 | Codes for the representation of names of countries and their subdivisions Part 1: Country codes |
| ISO/HL7 27953-1:2011 | Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1: Framework for adverse event reporting |
| ISO/IEC 15415:2011 | Information technology Automatic identification and data capture techniques Bar code symbol print quality test specification Two-dimensional symbols |
| ISO/IEC 5218:2004 | Information technology Codes for the representation of human sexes |
| 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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