Abstract
Ïã¸ÛÁùºÏ²Ê¿ª½±/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 Ïã¸ÛÁùºÏ²Ê¿ª½± IDMP standards (Ïã¸ÛÁùºÏ²Ê¿ª½± 11615, Ïã¸ÛÁùºÏ²Ê¿ª½± 11616, Ïã¸ÛÁùºÏ²Ê¿ª½± 11238, Ïã¸ÛÁùºÏ²Ê¿ª½± 11239 and Ïã¸ÛÁùºÏ²Ê¿ª½± 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 Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 20443:2017 to support successful information exchange.
General information
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Status: PublishedPublication date: 2017-10Stage: International Standard to be revised [90.92]
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Edition: 1Number of pages: 202
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Technical Committee :Ïã¸ÛÁùºÏ²Ê¿ª½±/TC 215ICS :35.240.80
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Life cycle
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Now
PublishedÏã¸ÛÁùºÏ²Ê¿ª½±/TS 20443:2017
A standard is reviewed every 5 years
Stage: 90.92 (To be revised) -
Will be replaced by
Under developmentÏã¸ÛÁùºÏ²Ê¿ª½±/AWI TS 20443
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