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ČSN EN ISO 11615 (981035)
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information
Translate name
STANDARD published on 1.6.2018
The information about the standard:
Designation standards: ČSN EN ISO 11615
Classification mark: 981035
Catalog number: 504771
Publication date standards: 1.6.2018
SKU: NS-848627
The number of pages: 96
Approximate weight : 319 g (0.70 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 11615 (981035):
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
These changes apply to this standard:
ČSN EN ISO 11615:2018/A1 (981035)
Change
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Zdravotnická informatika - Identifikace léčivých přípravků - Datové prvky a jejich struktura jednoznačnou identifikaci a výměnu informací o regulovaných léčivých přípravcích (Norma k přímému použití jako ČSN).
Change published on 1.2.2023
Selected format: English - Print design (9.40 USD)
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Preview of the standard ČSN EN ISO 11615 (981035)
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