ISO 11615:2017

Status : Published (To be revised)

This standard will be replaced by ISO/AWI 11615

	Format	Language
std 1 194	PDF + ePub
std 2 194	Paper

CHF194

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Abstract

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.

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General information

Status
: Published

Publication date
: 2017-10

Stage
: International Standard to be revised [90.92]
Edition
: 2

Number of pages
: 79
Technical Committee :
ISO/TC 215

ICS :
35.240.80
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