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 | prEN ISO 11615 rev |
|---|---|
| Title | Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information |
| Work Item Number | 00251410 |
| Abstract/Scope | ISO 11615:2017 establishes definitions and 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, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, 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 use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017. |
| Status |
Under Drafting
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| Reference Document |
ISO 11615 (EQV)
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| date of Availability (DAV) | |
| ICS | |
| 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) | |
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| date of Availability (DAV) (2) | |
| date of Announcement (DOA) (3) | |
| date of Publication (DOP) (4) | |
| date of Withdrawal (DOW) (5) |
Relations
| Supersedes |
EN ISO 11615:2017/A1:2022
EN ISO 11615:2017 |
|---|---|
| Superseded by |
(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.