Cookies
We need your consent to use the individual data so that you can see information about your interests, among other things. Click "OK" to give your consent.
ČSN EN ISO 11616 (981036)
Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information
Translate name
STANDARD published on 1.6.2018
The information about the standard:
Designation standards: ČSN EN ISO 11616
Classification mark: 981036
Catalog number: 504772
Publication date standards: 1.6.2018
SKU: NS-848628
The number of pages: 48
Approximate weight : 144 g (0.32 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 11616 (981036):
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, ISO 11616:2017 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. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017
Preview of the standard ČSN EN ISO 11616 (981036)
We recommend:
Technical standards updating
Do you want to make sure you use only the valid technical standards?
We can offer you a solution which will provide you a monthly overview concerning the updating of standards which you use.
Would you like to know more? Look at this page.
