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 20443:2018 |
|---|---|
| Title | Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017) |
| Work Item Number | 00251318 |
| Abstract/Scope | ISO/TS 20443:2017 defines 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, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to 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 normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange. |
| Status |
Published
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| Reference Document |
ISO/TS 20443:2017 (EQV)
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| date of Availability (DAV) | 2018-05-16 |
| ICS | 35.240.80 - IT applications in health care technology |
| A-Deviation(s) | |
| Special National Condition(s) |
Legal
| Directive(s) | |
|---|---|
| Mandate(s) | |
| Citation in OJEU |
Implementation Dates
| date of Ratification (DOR) (1) | 2018-05-13 |
|---|---|
| date of Availability (DAV) (2) | 2018-05-16 |
| date of Announcement (DOA) (3) | 2018-08-31 |
| date of Publication (DOP) (4) | |
| date of Withdrawal (DOW) (5) |
Relations
| Supersedes | |
|---|---|
| Superseded by | prCEN ISO/TS 20443 rev |
| Normative reference (6) |
ISO 11238
ISO 11239 ISO 11240 ISO 11615 ISO 11616 ISO 3166-1 ISO 8601 ISO/HL7 21731 ISO/IEC 5218 ISO/TS 20440 |
| 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.