oSIST prEN ISO 16791:2025

SLOVENSKI STANDARD
01-junij-2025
Zdravstvena informatika - Zahteve za mednarodne strojno berljive kode za
pakiranje zdravil (ISO/DIS 16791:2025)
Health informatics - Requirements for international machine-readable coding of
medicinal product package identifiers (ISO/DIS 16791:2025)
Medizinische Informatik - Anforderungen für internationale maschinenlesbare
Kodierungen von Identifikatoren für Arzneimittelpackungen (ISO/DIS 16791:2025)
Informatique de santé - Exigences relatives au codage international lisible par machine
des identifiants de paquetage de médicaments (ISO/DIS 16791:2025)
Ta slovenski standard je istoveten z: prEN ISO 16791
ICS:
35.040.50 Tehnike za samodejno Automatic identification and
razpoznavanje in zajem data capture techniques
podatkov
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 16791
ISO/TC 215
Health informatics — Requirements
Secretariat: ANSI
for international machine-readable
Voting begins on:
coding of medicinal product
2025-03-03
package identifiers
Voting terminates on:
2025-07-04
Informatique de santé — Exigences relatives au codage
international lisible par machine des identifiants de paquetage de
médicaments
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 16791:2025(en)
DRAFT
ISO/DIS 16791:2025(en)
International
Standard
ISO/DIS 16791
ISO/TC 215
Health informatics — Requirements
Secretariat: ANSI
for international machine-readable
Voting begins on:
coding of medicinal product
2025-03-03
package identifiers
Voting terminates on:
Informatique de santé — Exigences relatives au codage
international lisible par machine des identifiants de paquetage de
médicaments
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 16791:2025(en)
ii
ISO/DIS 16791:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions .1
3.2 Abbreviated terms .6
4 Procedural background . 6
4.1 General .6
4.2 Identification .6
4.3 International machine-readable coding .7
4.4 Medicinal product .7
4.5 Labelling .8
4.6 Package identifier .8
4.7 Serialization .9
5 Usage requirements . 9
5.1 General .9
5.2 Traceability .10
5.2.1 Principles .10
5.2.2 Guidelines .11
5.3 Measures to combat falsification of medicines . 12
5.3.1 Principles . 12
5.3.2 Guidelines for both approaches . 13
5.3.3 Product authentication . 13
5.3.4 Supply chain integrity .14
5.4 Improving patient safety at point of care .14
5.4.1 Principles .14
5.4.2 Guidelines .14
5.5 Support of healthcare systems . 15
5.5.1 Principles . 15
5.5.2 Guidelines .16
5.6 Procurement and stock management .16
5.6.1 Principles .16
5.6.2 Guidelines .17
5.7 Overview of guidelines .17
6 Economic aspects . 17
6.1 General .17
6.2 Manufacturer perspective .18
6.3 Healthcare provider perspective .18
Annex A (informative) Relationship between PhPID and MPID . 19
Annex B (informative) Packaging hierarchy, relationship between MPID, PCID and GTIN®.21
Annex C (informative) Identification of trade items and logistic units.23
Annex D (informative) Examples for Package Identifier .24
Annex E (informative) Personalized Medicine .33
Annex F (informative) Accessing electronic product information (ePI) by scanning the supply
chain unique identifier .34
Bibliography .36

iii
ISO/DIS 16791:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part
...