STN EN ISO 11616
| Name: | STN EN ISO 11616 |
| Validity: | Valid |
| Number of pages: | 46 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Zdravotnícka informatika. Identifikácia liekov. Dátové prvky a štruktúry na jednoznačnú identifikáciu a výmenu informácií o regulovanom farmaceutickom výrobku (ISO 11616: 2017) |
| English title | Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017) |
| Release Date: | 01. 06. 2018 |
| Date of withdrawal: | |
| ICS: | 35.240.80 |
| Sorting character/National clasification code | 84 8114 |
| Level of incorporation: | idt EN ISO 11616:2017, idt ISO 11616:2017 |
| Official Journal | 05/18 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 11616:2013-04 (84 8114) |
| Note in Official Journal: | |
| Subject of the standard: | This document is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, this document is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ... |
| Preview: | Náhľad normy (PDF) |