PD 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
Hardcopy , PDF
English
24-05-2018
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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/establishment
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.
| Committee |
IST/35
|
| DocumentType |
Standard
|
| Pages |
212
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
This document defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
Taken together, all ISO IDMP standards (ISO11615, ISO11616, ISO11238, ISO11239 and ISO11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in this document to support successful information exchange.
| Standards | Relationship |
| CEN ISO/TS 20443:2018 | Identical |
| ISO/TS 20443:2017 | 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 |
| 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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