Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017)

ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.
Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017.
Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für ISO 11616 Datenelemente und -strukturen zur eindeutigen Identifikation und zum Austausch von Informationen über pharmazeutische Produkte (ISO/TS 20451:2017)

Informatique de santé - Identification des médicaments - Lignes directrices pour l’implémentation des éléments de données et structures ISO 11616 pour l’identification unique et l’échange d’informations réglementées sur les produits pharmaceutiques (ISO/TS 20451:2017)

Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za uporabo ISO 11616 podatkovnih elementov in struktur za enotno identifikacijo in izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO/TS 20451:2017)

Standard ISO/TS 20451:2017 določa opredelitve, ki so potrebne za povezavo farmacevtskih izdelkov z ustreznim naborom PhPID-jev v skladu s standardom ISO 11616.
Namen farmacevtskih identifikatorjev in elementov je predstaviti farmacevtske izdelke, kot so predstavljeni v medicinskem izdelku in kot to določa Regulativni organ za zdravila (MRA). Zbirka standardov ISO IDMP se lahko uporabi za izjemno uporabo medicinskih izdelkov, vendar trenutno ne spada na področje uporabe standarda ISO/TS 20451:2017.
Sklice na standarde ISO 11238, ISO 11239, ISO 11240 in ISO 11615 ter standarde o sporočanju HL7 (HL7 – referenčni informacijski model (RIM), HL7 V3 – splošni model za izdelke (CPM) in HL7 V3 – strukturirano označevanje izdelkov (SPL)) je mogoče uporabiti za informacije o farmacevtskih izdelkih v kontekstu standarda ISO/TS 20451:2017.

General Information

Status
Published
Publication Date
15-May-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
16-May-2018
Completion Date
16-May-2018

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 20451:2018
01-september-2018
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Smernice za
uporabo ISO 11616 podatkovnih elementov in struktur za enotno identifikacijo in
izmenjavo predpisanih informacij o farmacevtskih izdelkih (ISO/TS 20451:2017)

Health informatics - Identification of medicinal products - Implementation guidelines for

ISO 11616 data elements and structures for the unique identification and exchange of

regulated pharmaceutical product information (ISO/TS 20451:2017)

Medizinische Informatik - Identifikation von Arzneimitteln - Implementierungsleitfaden für

ISO 11616 Datenelemente und -strukturen zur eindeutigen Identifikation und zum
Austausch von Informationen über pharmazeutische Produkte (ISO/TS 20451:2017)
Informatique de santé - Identification des médicaments - Lignes directrices pour

l’implémentation des éléments de données et structures ISO 11616 pour l’identification

unique et l’échange d’informations réglementées sur les produits pharmaceutiques
(ISO/TS 20451:2017)
Ta slovenski standard je istoveten z: CEN ISO/TS 20451:2018
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 20451:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 20451:2018
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SIST-TS CEN ISO/TS 20451:2018
CEN ISO/TS 20451
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2018
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - Identification of medicinal products -
Implementation guidelines for ISO 11616 data elements
and structures for the unique identification and exchange
of regulated pharmaceutical product information (ISO/TS
20451:2017)

Informatique de santé - Identification des médicaments Medizinische Informatik - Identifikation von

- Lignes directrices pour l'implémentation des Arzneimitteln - Implementierungsleitfaden für ISO

éléments de données et structures ISO 11616 pour 11616 Datenelemente und -strukturen zur eindeutigen

l'identification unique et l'échange d'informations Identifikation und zum Austausch von Informationen

réglementées sur les produits pharmaceutiques über pharmazeutische Produkte (ISO/TS 20451:2017)

(ISO/TS 20451:2017)

This Technical Specification (CEN/TS) was approved by CEN on 13 May 2018 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to

submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS

available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in

parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 20451:2018 E

worldwide for CEN national Members.
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CEN ISO/TS 20451:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Endorsement notice ..................................................................................................................................................... 3

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SIST-TS CEN ISO/TS 20451:2018
CEN ISO/TS 20451:2018 (E)
European foreword

This document (CEN ISO/TS 20451:2018) has been prepared by Technical Committee ISO/TC 215 "

Health informatics " in collaboration with Technical Committee CEN/TC 251 “Health informatics” the

secretariat of which is held by NEN.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO/TS 20451:2017 has been approved by CEN as CEN ISO/TS 20451:2018 without any

modification.
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SIST-TS CEN ISO/TS 20451:2018
TECHNICAL ISO/TS
SPECIFICATION 20451
First edition
2017-10
Health informatics — Identification
of medicinal products —
Implementation guidelines for ISO
11616 data elements and structures
for the unique identification and
exchange of regulated pharmaceutical
product information
Informatique de santé — Identification des médicaments — Lignes
directrices pour l’implémentation des éléments de données et
structures ISO 11616 pour l’identification unique et l’échange
d’informations réglementées sur les produits pharmaceutiques
Reference number
ISO/TS 20451:2017(E)
ISO 2017
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ISO/TS 20451:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Conformance ............................................................................................................................................................................................................. 2

5 Concepts required for the unique identification of pharmaceutical products ....................................2

5.1 General considerations for elements required for the unique identification of

pharmaceutical products ............................................................................................................................................................... 2

5.2 Principles required for the unique identification of a pharmaceutical product ............................ 2

6 Identifying characteristics for the identification of pharmaceutical products ...................................3

6.1 Pharmaceutical product identification strata and levels .................................................................................... 3

6.2 PhPID specified substance ............................................................................................................................................................ 4

6.3 Pharmaceutical product specified substance identification (PhPID SpSub) ..................................... 5

6.4 Cardinality ................................................................................................................................................................................................... 5

6.5 Representation of strength concentration ...................................................................................................................... 6

6.6 Pharmaceutical product identifier (PhPID) ................................................................................................................... 6

6.7 PhPID algorithm and product code concept.................................................................................................................. 7

7 Ingredient, substance and strength .................................................................................................................................................. 8

7.1 General considerations .................................................................................................................................................................... 8

7.2 Ingredient .................................................................................................................................................................................................... 9

7.2.1 Ingredient role ................................................................................................................................................................... 9

7.2.2 Substance ............................................................................................................................................................................10

7.2.3 Specified substance ....................................................................................................................................................10

7.2.4 Specified substance group ....................................................................................................................................10

7.2.5 Confidentiality indicator ........................................................................................................................................11

7.2.6 Strength ................................................................................................................................................................................11

7.2.7 Pharmaceutical product code concept for representing the normalised

strength for liquid preparations ......................................................................................................................11

7.2.8 Strength (presentation) ..........................................................................................................................................12

7.2.9 Strength (concentration) .......................................................................................................................................12

7.2.10 Measurement point ....................................................................................................................................................13

7.2.11 Country ...................................................................... ............................................................................................................13

7.2.12 Reference strength ......................................................................................................................................................13

7.2.13 Reference substance ..................................................................................................................................................13

7.2.14 Reference specified substance ..........................................................................................................................13

7.2.15 Reference strength ......................................................................................................................................................13

7.2.16 Reference strength measurement point ...................................................................................................14

7.2.17 Reference strength country .................................................................................................................................14

8 Pharmaceutical product: adjuvants and devices .............................................................................................................14

8.1 General considerations .................................................................................................................................................................14

8.1.1 Detailed description of pharmaceutical product and device information ..................14

8.1.2 Pharmaceutical product .........................................................................................................................................15

8.1.3 Pharmaceutical product characteristics ...................................................................................................17

8.1.4 Device (pharmaceutical product) ..................................................................................................................18

Annex A (normative) Messaging: Ingredient, substance and strength ..........................................................................19

Annex B (normative) Messaging: Pharmaceutical product and device .........................................................................33

Annex C (informative) Examples ............................................................................................................................................................................40

Annex D (informative) Examples of representation of strength ...........................................................................................45

© ISO 2017 – All rights reserved iii
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Bibliography .............................................................................................................................................................................................................................48

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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 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 215, Health informatics.

© ISO 2017 – All rights reserved v
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Introduction

This document gives guidelines for implementing ISO 11616, one of the five ISO IDMP standards. The

five ISO Standards and four ISO Technical Specifications, when used together, provide the basis for

exchanging data elements that will support the unique and unambiguous identification of Medicinal

Products. The primary purpose of this document is to provide technical guidance to software

implementers; short descriptions of business rationale are also included, where relevant, to provide

context. Thus, this document focuses on business and technical considerations for implementation

that will construct and parse well-formed, transmittable IDMP messages. Following transmission of

required data elements, unique identifiers are to be produced in conformance with the standards to

support applications where it is necessary to reliably identify and trace regulated biopharmaceutical

products. However, this document does not include extensive information on creation or maintenance

of identifier repositories. Reference is made to regional guidance/implementation guides to support

practical implementation within a given region/jurisdiction. The development of an ISO technical

report for identifying core principles for the maintenance of identifiers and terms for ISO IDMP is

to be developed and referenced for applicable ISO IDMP standards and corresponding technical

specifications.
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SIST-TS CEN ISO/TS 20451:2018
TECHNICAL SPECIFICATION ISO/TS 20451:2017(E)
Health informatics — Identification of medicinal products
— Implementation guidelines for ISO 11616 data elements
and structures for the unique identification and exchange
of regulated pharmaceutical product information
1 Scope

This document defines the concepts required to associate pharmaceutical products with an appropriate

set of PhPID(s) in accordance with ISO 11616.

Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a

Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards

can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of this

document.

Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7

Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured

Product Labelling (SPL) can be applied for pharmaceutical product information in the context of this

document.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country codes

ISO 11238, Health informatics — Identification of Medicinal Products — Data elements and structures for

the unique identification and exchange of regulated information on substances

ISO 11239, Health informatics — Identification of Medicinal Products — Data elements and structures for

the unique identification and exchange of regulated information on pharmaceutical dose forms, units of

presentation, routes of administration and packaging

ISO 11240, Health informatics — Identification of Medicinal Products — Data elements and structures for

the unique identification and exchange of units of measurement

ISO 11615, Health informatics — Identification of Medicinal Products — Data elements and structures for

the unique identification and exchange of regulated Medicinal Product information

ISO/TS 19844, Health informatics — Identification of Medicinal Products — Implementation guidelines

for data elements and structures for the unique identification and exchange of regulated information on

substances

ISO/TS 20440, Health informatics — Identification of Medicinal Products — Implementation guide for

ISO 11239 data elements and structures for the unique identification and exchange of regulated information

on pharmaceutical dose forms, units of presentation, routes of administration and packaging

ISO/TS 20443, Health informatics — Identification of Medicinal Products — Implementation guidelines for

ISO 11615 data elements and structures for the unique identification and exchange of regulated Medicinal

Product information
© ISO 2017 – All rights reserved 1
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3 Terms and definitions
No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
4 Conformance

— Mandatory: Defining elements necessary for the unique identification of Medicinal Products per the

ISO IDMP standards/technical specifications.

— Conditional: Conditional applies to the “within category” data elements, as applicable, when there

are alternative data sources for a given data element(s) to identify a medicinal/pharmaceutical

product. Regional implementation of the ISO IDMP standards/technical specifications may elevate

the conditional conformance categories to “mandatory” per regional requirements.

— Optional: When listed at the category level (e.g. specified substance), optional corresponds to

ISO categories or data elements that are not absolutely necessary for the unique identification of

medicinal/pharmaceutical products according to the ISO IDMP standards/technical specifications.

Regional implementation of the ISO IDMP standards/technical specifications may elevate the

optional conformance categories to “mandatory” or “conditional” per regional requirements.

5 Concepts required for the unique identification of pharmaceutical products

5.1 General considerations for elements required for the unique identification of

pharmaceutical products

This clause, along with Annex A and Annex B, describes the elements and messaging required to

uniquely identify and characterise a pharmaceutical product. It provides the requirements to support

pharmaceutical product identification. Examples are given in Annex C.

Pharmaceutical product identification (PhPID) shall be based on the following subset of elements that

describe the pharmaceutical product (see Figure 1):
a) active substance(s)/specified substance(s);

NOTE The substance(s) within the ingredient role “active” and “adjuvant” are utilised to define the PhPID.

b) strength(s), strength units (units of measurement and/or unit of presentation);

c) reference strength(s) includes reference substance(s) (i.e. active moiety and its corresponding

strength);
d) administrable dose form;
e) medical device, when it is a component of a Medicinal Product.

5.2 Principles required for the unique identification of a pharmaceutical product

The following principles for the unique identification of a pharmaceutical product shall apply:

a) a Medicinal Product may relate to one or more pharmaceutical products as part of a treatment

regime [e.g. a kit, which might be a combination pack containing vaginal tablets (500 mg) and an

external vaginal cream (10 %)];
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b) the characterisation of the pharmaceutical product(s) based on the active substance(s)/specified

substance(s), the (reference) strength thereof, the administrable dose form(s), and the medical

device (e.g. a scaffolding for cell-based products) being part of the Medicinal Product (e.g.

drug/device combination);

c) the description of the pharmaceutical product(s) in the pharmaceutical dose form approved for

administration, where applicable, after reconstitution and as authorised in accordance with the

regulated product information;

d) the association of the regulated (investigational) Medicinal Product and the pharmaceutical

product(s) using the PhPID(s).
6 Identifying characteristics for the identification of pharmaceutical products
6.1 Pharmaceutical product identification strata and levels

PhPID sets shall be represented within two strata (active substance stratum and specified substance

stratum), both of which contain four PhPID identification levels, for each pharmaceutical product

contained in a Medicinal Product.

PhPID sets shall be generated using the substance standard (see ISO 11238 and ISO/TS 19844), the

strength and administrable dose form section (see ISO 11239 and ISO/TS 20440) and the unit(s) of

measurement standard (see ISO 11240) as illustrated below.

Reference strength shall be repeated in both PhPID strata. The reference strength shall be derived from

the active moiety/moieties of an active substance(s) depending on the specific product characteristics.

All the PhPID strata can be described at four different levels from 1 to 4 as shown in Table 1.

Table 1 — Four levels of PhPID
PhPID_SUB_L1 → substance(s)
PhPID_SUB_L2 → substance(s) + strength + reference strength
PhPID active
substance PhPID_SUB_L3 → substance(s) + administrable dose form
stratum
PhPID_SUB_L4 → substance(s) + strength + reference strength
+ administrable dose form
PhPID_SpSUB_L1 → specified substance(s)
PhPID_SpSUB_L2 → specified substance(s) + strength + reference strength
PhPID specified
substance PhPID_SpSUB_L3 → specified substance(s) + administrable dose form
stratum
PhPID_SpSUB_L4 → specified substance(s) + strength + reference strength
+ administrable dose form

A pharmaceutical product may refer to a drug that is associated with a medical device. In this instance,

the device term and term ID (i.e. unique device identifier) shall be displayed with the active substance(s)

and specified substance(s) terms for the product at all applicable PhPID levels. This association shall

be made by directly associating the assigned PhPIDs to a Medicinal Product and its corresponding

MPID/PCID as outlined in ISO 11615 and ISO/TS 20443.
Strength is not applicable to a device.

A region may further refine the requirements in relation to specification of the medical device as part

of this document at implementation so that this information is to be specified only if required.

A pharmaceutical product may refer to a drug that is associated with an adjuvant (e.g. vaccine). In this

instance, the adjuvant term and term ID shall be displayed with the active substance(s) and specified

substance(s) terms for the product at all applicable PhPID levels. This association shall be made by

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directly associating the assigned PhPIDs to a Medicinal Product and its corresponding MPID and PCID

as outlined in ISO 11615 and ISO/TS 20443.

Strength shall indicate quantity, unit of measurement and/or unit of presentation.

Administrable dose form is derived from the pharmaceutical product.

Placebos shall be captured as active substances when utilised as a comparator. Regional implementation

guides will provide more information as some regional regulation defines what is considered a placebo

or active substance.
6.2 PhPID specified substance

As described in ISO 11238, specified substance(s) shall capture detailed characteristics of single

substances
...

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