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ISO 11615:2017

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information

standard by International Organization for Standardization , 10/01/2017

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Full Description

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.

 

Product Details

Edition:
2
Published:
10/01/2017
Number of Pages:
88
File Size:
1 file , 4.7 MB
Same As:
DIN EN ISO 11615, BS EN ISO 11615:2017
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 11615:2017

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    Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information

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  2. ISO 11615:2012


    Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 11615:2017/Amd1:2022


    - Amendment 1: Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information - Amendment 1