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 | EN ISO 11239:2023 |
|---|---|
| Title | 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 (ISO 11239:2023) |
| Work Item Number | 00251363 |
| Abstract/Scope | This document specifies: — the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products; — a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange; — a mechanism for the versioning of the concepts in order to track their evolution; — rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way. |
| Status |
Published
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| Reference Document |
ISO 11239:2023 (EQV)
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| date of Availability (DAV) | 2023-06-14 |
| 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) | 2023-05-09 |
|---|---|
| date of Availability (DAV) (2) | 2023-06-14 |
| date of Announcement (DOA) (3) | 2023-09-30 |
| date of Publication (DOP) (4) | 2023-12-31 |
| date of Withdrawal (DOW) (5) | 2023-12-31 |
Relations
| Supersedes | EN ISO 11239:2012 |
|---|---|
| Superseded by | |
| Normative reference (6) |
ISO 3166-1
ISO 639-1 |
| 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.