Standard Svensk standard · SS-EN ISO 11616:2017

Hälso- och sjukvårdsinformatik - Identifiering av läkemedel - Dataelement och strukturer för identifiering och utbyte av reglerad läkemedelsinformation (ISO 11616:2017)

Status: Gällande

ISO 11616:2017 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, 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.


Hälso- och sjukvårdsinformatik (35.240.80)


Språk: Engelska

Framtagen av: Hälso- och sjukvårdsinformatik, SIS/TK 334

Internationell titel: Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)

Artikelnummer: STD-8030063

Utgåva: 2

Fastställd: 2017-12-13

Antal sidor: 52

Ersätter: SS-EN ISO 11616:2012