ISO/TS 16791:2014
Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
ISO/TS 16791:2014 provides guidance on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product.
ISO/TS 16791:2014 outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies e.g. Radio Frequency Identification (RFID).
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.1.1
Section sec_3.1.2
Section sec_3.1.3
Section sec_3.1.4
Section sec_3.1.5
Section sec_3.1.6
Section sec_3.1.7
Section sec_3.1.8
Section sec_3.1.9
Section sec_3.1.10
Section sec_3.1.11
Section sec_3.1.12
Section sec_3.1.13
Section sec_3.1.14
Section sec_3.1.15
Section sec_3.1.16
Section sec_3.1.17
Section sec_3.1.18
Section sec_3.1.19
Section sec_3.1.20
Section sec_3.1.21
Section sec_3.1.22
Section sec_3.1.23
Section sec_3.1.24
Section sec_3.1.25
Section sec_3.1.26
Section sec_3.1.27
Section sec_3.1.28
Section sec_3.1.29
Section sec_3.1.30
Section sec_3.1.31
Section sec_3.1.32
Section sec_3.2
Section sec_4
Section sec_4.1
Section sec_4.2
Section sec_4.3
Section sec_4.4
Section sec_4.5
Section sec_4.6
Section sec_4.7
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.1.1
Section sec_5.2.1.2
Section sec_5.2.1.3
Section sec_5.2.2
Section sec_5.3
Section sec_5.3.1
Section sec_5.3.1.1
Section sec_5.3.1.2
Section sec_5.3.1.3
Section sec_5.3.2
Section sec_5.4
Section sec_5.4.1
Section sec_5.4.2
Section sec_5.5
Section sec_5.5.1
Section sec_5.5.2
Section sec_5.6
Section sec_5.6.1
Section sec_5.6.2
Section sec_5.7
Table tab_1
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.3
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Figure fig_A.1
Annex sec_B
Figure fig_B.1
Annex sec_C
Figure fig_C.1
Annex sec_D
Table tab_D.1
Reference ref_1
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 Terms
3.2 Abbreviations
4 Procedural background
4.1 General
4.2 Identification
4.3 International machine readable coding
4.4 Medicinal product
4.5 Labelling
4.6 Package identifier
4.7 Serialization
5 Usage requirements
5.1 General
5.2 Traceability
5.3 Measures to combat falsification of medicines
5.4 Improving patient safety at point of care
5.5 Support of healthcare systems
5.6 Procurement and stock management
5.7 Overview of the normative options
6 Economic aspects
6.1 General
6.2 Manufacturer perspective
6.3 Healthcare provider perspective
Annex A (informative) Relationship between PhPID and MPID (Referencing ISO 11615 and ISO 11616)
Annex B (informative) Packaging hierarchy
Annex C (informative) Relationship between MPID, PCID and GTIN
Annex D (informative) Examples for Package Identifier
Bibliography
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.1.1
Section sec_3.1.2
Section sec_3.1.3
Section sec_3.1.4
Section sec_3.1.5
Section sec_3.1.6
Section sec_3.1.7
Section sec_3.1.8
Section sec_3.1.9
Section sec_3.1.10
Section sec_3.1.11
Section sec_3.1.12
Section sec_3.1.13
Section sec_3.1.14
Section sec_3.1.15
Section sec_3.1.16
Section sec_3.1.17
Section sec_3.1.18
Section sec_3.1.19
Section sec_3.1.20
Section sec_3.1.21
Section sec_3.1.22
Section sec_3.1.23
Section sec_3.1.24
Section sec_3.1.25
Section sec_3.1.26
Section sec_3.1.27
Section sec_3.1.28
Section sec_3.1.29
Section sec_3.1.30
Section sec_3.1.31
Section sec_3.1.32
Section sec_3.2
Section sec_4
Section sec_4.1
Section sec_4.2
Section sec_4.3
Section sec_4.4
Section sec_4.5
Section sec_4.6
Section sec_4.7
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.1.1
Section sec_5.2.1.2
Section sec_5.2.1.3
Section sec_5.2.2
Section sec_5.3
Section sec_5.3.1
Section sec_5.3.1.1
Section sec_5.3.1.2
Section sec_5.3.1.3
Section sec_5.3.2
Section sec_5.4
Section sec_5.4.1
Section sec_5.4.2
Section sec_5.5
Section sec_5.5.1
Section sec_5.5.2
Section sec_5.6
Section sec_5.6.1
Section sec_5.6.2
Section sec_5.7
Table tab_1
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.3
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Figure fig_A.1
Annex sec_B
Figure fig_B.1
Annex sec_C
Figure fig_C.1
Annex sec_D
Table tab_D.1
Reference ref_1
Reference ref_2
Reference ref_3
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Reference ref_19
Reference ref_20
Reference ref_21
Reference ref_22
Reference ref_23
Reference ref_24
Reference ref_25
Reference ref_26
Reference ref_27
Reference ref_28
Reference ref_29
Reference ref_30
Reference ref_31
Reference ref_32
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 Terms
3.2 Abbreviations
4 Procedural background
4.1 General
4.2 Identification
4.3 International machine readable coding
4.4 Medicinal product
4.5 Labelling
4.6 Package identifier
4.7 Serialization
5 Usage requirements
5.1 General
5.2 Traceability
5.3 Measures to combat falsification of medicines
5.4 Improving patient safety at point of care
5.5 Support of healthcare systems
5.6 Procurement and stock management
5.7 Overview of the normative options
6 Economic aspects
6.1 General
6.2 Manufacturer perspective
6.3 Healthcare provider perspective
Annex A (informative) Relationship between PhPID and MPID (Referencing ISO 11615 and ISO 11616)
Annex B (informative) Packaging hierarchy
Annex C (informative) Relationship between MPID, PCID and GTIN
Annex D (informative) Examples for Package Identifier
Bibliography