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 11616:2017 |
|---|---|
| Title | Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017) |
| Work Item Number | 00251327 |
| Abstract/Scope | ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017. |
| Status |
Published
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| Reference Document |
ISO 11616:2017 (EQV)
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| date of Availability (DAV) | 2017-12-06 |
| 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) | 2017-11-17 |
|---|---|
| date of Availability (DAV) (2) | 2017-12-06 |
| date of Announcement (DOA) (3) | 2018-03-31 |
| date of Publication (DOP) (4) | 2018-06-30 |
| date of Withdrawal (DOW) (5) | 2018-06-30 |
Relations
| Supersedes | EN ISO 11616:2012 |
|---|---|
| Superseded by | prEN ISO 11616 rev |
| Normative reference (6) |
ISO 11238
ISO 11239 ISO 11240 ISO 11615:2017
ISO 3166-1
ISO/TS 19844 ISO/TS 20440 ISO/TS 20443 ISO/TS 20451 |
| 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.