EN ISO 11615:2017/A1:2022 PDF

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1 (ISO 11615:2017/Amd 1:2022)

Название (английский):

EN ISO 11615:2017/A1:2022

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 8
Дата публикации:: 21 сентября 2022 г.
Издание:: CEN EN 11615 edition 1 version 1
ICS:: 35.240.80

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Описание (английский):

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Технические детали

Технический комитет: CEN/TC 251 - Medical informatics
SKU: EN ISO 11615:2017/A1:2022

Abstract

Overview

EN ISO 11615:2017/A1:2022 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (Amendment 1) is a CEN-endorsed amendment to ISO 11615:2017. Approved by CEN on 12 August 2022 and endorsed for national adoption by March 2023, this document supports consistent, machine-readable representation of regulated medicinal product information across regulatory, clinical and healthcare systems.

Key topics and technical updates

Scope: defines data elements and data structures used for the unique identification and exchange of regulated medicinal product information (IDMP).
Amendment highlights:
- Revision to the Introduction to reference other normative IDMP and messaging standards to support successful information exchange.
- Addition to clause 7.5.4 pointing implementers to new translation/synonym resources.
- New informative Annex C providing language translations and synonyms for class names and attributes used in the IDMP data model (complements Annexes A and B).
Content emphasis:
- Consistent semantic definitions for class names, attributes and data elements in the IDMP model.
- Implementation considerations for regional/local language translations and synonym usage to ensure semantic interoperability.
Maintenance and provenance:
- Prepared by ISO/TC 215 (Health informatics) in collaboration with CEN/TC 251; text adopted unchanged by CEN as EN ISO 11615:2017/A1:2022.
- Annex C translations and full lists are available via the ISO Standards Maintenance Portal: https://standards.iso.org/iso/11615/ed-2/en/amd/1

Practical applications

Improves interoperability of medicinal product data across:
- National medicines agencies and regulatory submissions
- Pharmacovigilance and safety reporting systems
- Clinical information systems, e‑prescribing and pharmacy IT
- Healthcare data exchanges and public health reporting
Helps implementers map local terminology and multilingual labels to standard IDMP concepts, reducing ambiguity in cross-border data exchange and regulatory workflows.

Who should use this standard

Regulatory authorities and national competent authorities
Pharmaceutical companies (regulatory affairs, data management)
Health informatics vendors, EHR and e-prescribing system developers
Pharmacovigilance and safety surveillance teams
Hospitals, health insurers and governmental health IT programs seeking consistent medicinal product identification

Related standards and keywords

Related: ISO 11615 family (IDMP), IDMP messaging standards referenced in the amendment
SEO keywords: EN ISO 11615:2017/A1:2022, IDMP, identification of medicinal products, data elements, medicinal product information, health informatics, interoperability, pharmacovigilance, regulatory exchange, translations and synonyms

Overview

Key topics and technical updates

Scope: defines data elements and data structures used for the unique identification and exchange of regulated medicinal product information (IDMP).
Amendment highlights:
- Revision to the Introduction to reference other normative IDMP and messaging standards to support successful information exchange.
- Addition to clause 7.5.4 pointing implementers to new translation/synonym resources.
- New informative Annex C providing language translations and synonyms for class names and attributes used in the IDMP data model (complements Annexes A and B).
Content emphasis:
- Consistent semantic definitions for class names, attributes and data elements in the IDMP model.
- Implementation considerations for regional/local language translations and synonym usage to ensure semantic interoperability.
Maintenance and provenance:
- Prepared by ISO/TC 215 (Health informatics) in collaboration with CEN/TC 251; text adopted unchanged by CEN as EN ISO 11615:2017/A1:2022.
- Annex C translations and full lists are available via the ISO Standards Maintenance Portal: https://standards.iso.org/iso/11615/ed-2/en/amd/1

Practical applications

Improves interoperability of medicinal product data across:
- National medicines agencies and regulatory submissions
- Pharmacovigilance and safety reporting systems
- Clinical information systems, e‑prescribing and pharmacy IT
- Healthcare data exchanges and public health reporting
Helps implementers map local terminology and multilingual labels to standard IDMP concepts, reducing ambiguity in cross-border data exchange and regulatory workflows.

Who should use this standard

Regulatory authorities and national competent authorities
Pharmaceutical companies (regulatory affairs, data management)
Health informatics vendors, EHR and e-prescribing system developers
Pharmacovigilance and safety surveillance teams
Hospitals, health insurers and governmental health IT programs seeking consistent medicinal product identification

Related standards and keywords

Related: ISO 11615 family (IDMP), IDMP messaging standards referenced in the amendment
SEO keywords: EN ISO 11615:2017/A1:2022, IDMP, identification of medicinal products, data elements, medicinal product information, health informatics, interoperability, pharmacovigilance, regulatory exchange, translations and synonyms

EN ISO 11615:2017/A1:2022 PDF

Технические детали

Abstract

Overview

Key topics and technical updates

Practical applications

Who should use this standard

Related standards and keywords

Похожие стандарты

Abstract

Overview

Key topics and technical updates

Practical applications

Who should use this standard

Related standards and keywords

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