About CEN
The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
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Project
| Reference | CEN ISO/TS 20440:2023 |
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| Title | Health informatics - Identification of medicinal products - Implementation guidelines 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/TS 20440:2023) |
| Work Item Number | 00251364 |
| Abstract/Scope | This document describes 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. Based on the principles outlined in this document, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts. This document is intended for use by: — any organization that might be responsible for developing and maintaining such controlled vocabularies; — any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created; — owners of databases who want to map their own terms to a standardized list of controlled vocabularies; — other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept. This document does not specify a particular terminology for the implementation of ISO 11239. |
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Published
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| Reference Document |
ISO/TS 20440:2023 (EQV)
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| date of Availability (DAV) | 2023-04-12 |
| ICS | 35.240.80 - IT applications in health care technology |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | |
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| Mandate(s) | |
| Citation in OJEU |
Implementation Dates
| date of Ratification (DOR) (1) | 2023-03-10 |
|---|---|
| date of Availability (DAV) (2) | 2023-04-12 |
| date of Announcement (DOA) (3) | 2023-07-31 |
| date of Publication (DOP) (4) | |
| date of Withdrawal (DOW) (5) |
Relations
| Supersedes | CEN ISO/TS 20440:2016 |
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| Superseded by | |
| Normative reference (6) |
ISO 11239
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| Sales Points |
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(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
We also invite you to check (via the website) whether corrigenda and/or amendments shall be read in conjunction with the main standard.