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BS EN ISO 11616:2017

Current
Current

The latest, up-to-date edition.

Health informatics. Identification of medicinal products. Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

17-01-2018

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, and abbreviated terms
4 Conformance terminology and context as
   it relates to the ISO IDMP standards and
   corresponding IDMP technical specifications
5 Requirements
6 Description of the information modelling
   principles and practices
7 Identifying characteristics for the identification
   of pharmaceutical products
8 Relationship between MPID/PCID and PhPID
9 Relationship between IMPID/IPCID and PhPID
10 Conceptual model
Bibliography

Defines specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products.

This document is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, this document is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient.

This document is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level.

References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause2, to be applied in the context of this document.

Medicinal products for veterinary use are out of scope of this document.

Committee
IST/35
DevelopmentNote
Supersedes 10/30229870 DC. (11/2012) Supersedes 16/30344632 DC. (01/2018)
DocumentType
Standard
Pages
44
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 11616:2017 Identical
EN ISO 11616:2017 Identical

ENV 1613 : 1995 MEDICAL INFORMATICS - MESSAGES FOR EXCHANGE OF LABORATORY INFORMATION
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 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 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
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
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
ENV 12610 : DRAFT 1997 MEDICAL INFORMATICS - MEDICINAL PRODUCT IDENTIFICATION
CFR 21(PTS300-499) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 300-499
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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