S.R. CEN ISO/TS 20443:2018
Current
The latest, up-to-date edition.
HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR ISO 11615 DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO/TS 20443:2017)
Hardcopy , PDF
English
06-17-2018
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National Foreword
European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Message exchange
5 Conformance terminology and context as it
relates to the ISO IDMP standards and
corresponding technical specifications
6 Maintenance of IDMP data elements and IDMP identifiers
7 Why standardisation of identification of Medicinal
Products is needed
8 General considerations
9 Information for an authorised Medicinal Product
10 Investigational Medicinal Product Identifier (IMPID)
Annex A (normative) - Medicinal Product
Annex B (normative) - Marketing authorisation
Annex C (normative) - Packaged Medicinal
Product (including manufactured item and device)
Annex D (normative) - Ingredient, substance and strength
Annex E (normative) - Pharmaceutical product and device
Annex F (normative) - Clinical particulars
Annex G (normative) - Organisation
Annex H (normative) - Manufacturer/establishmentc
Annex I (normative) - Investigational Medicinal Product
Annex J (normative) - SPL documents
Annex K (informative) - Abbreviations
Bibliography
Describes 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 |
220
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| CEN ISO/TS 20443:2018 | 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 |
| 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/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/HL7 21731:2014 | Health informatics HL7 version 3 Reference information model Release 4 |
| ISO/HL7 27953-2:2011 | Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR |
| ISO 6709:2008 | Standard representation of geographic point location by coordinates |
| 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 2382:2015 | Information technology — Vocabulary |
| 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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