BS EN 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, 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.
This document 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 this document.
Medicinal products for veterinary use are out of scope of this document.
Cross References:ISO 11239
ISO 11240
ISO 11238
ISO/TS 20451
ISO/TS 20443
ISO 3166-1
ISO/TS 19844
ISO/TS 20440
ISO 11615:2017
ISO/HL7 27953?1
ISO/HL7 27951
ISO/IEC Guide 99
ISO 8601
ISO/HL7 27953?2
ENV 13607
ISO 639-1
ISO 6709
ISO/IEC 11404
ISO 1087-1
ISO/TS 16791
ISO/IEC 5218
ISO 21090
ISO/IEC 2382
ENV 1613:1995
ENV 12610:1997
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 1.5 MB |
| ISBN(s) : | 9780580948794 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 42 |
| Product Code(s) : | 30344633, 30344633, 30344633 |
| Published : | 01/17/2018 |
| Same As : | BS EN ISO 11616:2017 |
