I.S. EN ISO 11616:2017
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 PHARMACEUTICAL PRODUCT INFORMATION (ISO 11616:2017)
Hardcopy , PDF
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, symbols, 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
Gives specific levels of information relevant to the identification of a medicinal product or group of medicinal products.
| Committee |
TC 251
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 11616:2017 | Identical |
| 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 |
| 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/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 12610:1997 | 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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