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PD CEN ISO/TS 20443:2018

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

24-05-2018

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.

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.

Committee
IST/35
DocumentType
Standard
Pages
212
PublisherName
British Standards Institution
Status
Current

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 : DRAFT 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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