ISO/TS 16791:2020 健康情報学—医薬品パッケージ識別子の国際的な機械可読コーディングの要件 | ページ 6

3.1.1

aggregation

aggregated packaging

hierarchical, parent-child relationship between a containing object (i.e. parent) and one or more objects (i.e. children) which are contained

Note 1 to entry: When the content of a delivery is not homogeneous, aggregation shall be provided by using a univocal identification of the delivery, such as with a Serial Shipping Container code (SSCC); see Annex C.

3.1.2

application identifier

AI

GS1® prefix that defines the meaning and purpose of the data element that follows, as defined in ISO/IEC 15418 and GS1® General Specifications

[SOURCE:ISO/IEC 19762:2016, 01.01.82]

3.1.3

automatic identification and data capture

AIDC

methods or technologies for automatically identifying objects, collecting data about them, and entering that data directly into computer systems, eliminating manual entry

Note 1 to entry: The methods or technologies typically considered as part of AIDC include barcodes which can be linear or 2-dimensional symbols and Radio Frequency Identification (RFID) tags/chips.

3.1.4

authentication

comparing the attributes of the object itself to what is known about objects of that origin

Note 1 to entry: Attributes include unique identifier besides overt, covert, and/or forensic solutions.

3.1.5

medicinal product batch identifier 1

BAID1

unique identifier allocated to a specific batch of a medicinal product, which appears on the outer packaging of the medicinal product

Note 1 to entry: It is constructed by using the batch number assigned by the manufacturer and the expiration date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of a medicinal product at the package level.

[SOURCE:ISO 11615:2017, 3.1.51]

Note 2 to entry: BAID1 is market specific.

3.1.6

medicinal product batch identifier 2

BAID2

unique identifier allocated to a specific batch of a medicinal product, which appears on the immediate packaging ここで, this is not the outer packaging

Note 1 to entry: It is constructed by using the batch number assigned by the manufacturer and the expiration date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of a medicinal product based at the level of the immediate container.

[SOURCE:ISO 11615:2017, 3.1.52]

Note 2 to entry: ‘immediate packaging’ corresponds frequently to ‘primary packaging’. See Annex B.

3.1.7

batch

lot

specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture

[SOURCE:ISO 11615:2017, 3.1.8 — modified, “lot” was added as a preferred term.]

3.1.8

batch number

lot number

identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing process at a specific point of time

[SOURCE:ISO 11615:2017, 3.1.9 — modified, “lot number” was added as a preferred term.]

Note 1 to entry: A batch number permits its manufacturing history to be traced.

Note 2 to entry: A batch number is made of series of ASCII characters.

3.1.9

barcode

optical machine-readable representation of data, showing data about the object to which it attaches

Note 1 to entry: Originally, barcodes represented data by varying the widths and spacings of parallel lines, and can be referred to as linear or one-dimensional (1D). Later they evolved into rectangles, dots, hexagons, and other geometric patterns in two dimensions (2D). Although 2D systems use a variety of symbols, they are generally referred to as barcodes as well.

3.1.10

dispense medication

prepare and give out a medicinal product in accordance with a prescription

Note 1 to entry: This includes assessing the pharmaceutical appropriateness including decision support.

Note 2 to entry: See also ISO/TS 19293:2018.

3.1.11

global trade item number

GTIN® ²

number that is used for the unique identification of trade items worldwide

[SOURCE:ISO/IEC 15420:2009, 3.7 — modified, digit length removed.]

Note 1 to entry: See Annex A for the relationship between MPID, PCID, and GTIN®.

3.1.12

healthcare system

organization of people, institutions, and resources to deliver healthcare services to meet the health needs of target populations

3.1.13

identification

way information about an object, such as a trade item, can be found in IT systems, such as databases

Note 1 to entry: It refers to a sequence of characters (numerals and/or alpha characters). The identifier is intended to be a unique sequence structured according to a globally agreed architecture or syntax, and can or cannot contain inbuilt significance.

3.1.14

identification schema namespace

container for a set of identifiers that allows the disambiguation of homonym identifiers residing in different identification schema

3.1.15

identifier

id

description that is sufficient to represent an object in a given environment identification schema

Note 1 to entry: This concept is generic and applies to all identifications mentioned in this document.

3.1.16

machine-readable code

code, readable by a machine, that contains information used to establish a relationship between a physical object such as a medicinal product package and data sources such as medical, production, logistical and/or reimbursement coding systems

3.1.17

manufacturing

manufacture

process of production from the acquisition of all materials through all processing stages, including final packaging

3.1.18

marketing authorization

authorization issued from a medicines regulatory agency that allows a medicinal product to be placed on the market

[SOURCE:ISO 11615:2017, 3.1.40]

3.1.19

marketing authorization holder

organization that holds the authorization for marketing a medicinal product in a region or country

[SOURCE:ISO 11615:2017, 3.1.41— modified,"or country" added.]

3.1.20

medicinal product

pharmaceutical product or combination of pharmaceutical products that may be administered to human beings for treating or preventing disease, with the aim/purpose of making a medical diagnosis or to restore, correct or modify physiological functions

Note 1 to entry: The same definition applies for animal health.

[SOURCE:ISO 11615:2017, 3.1.50, — modified, “(or animals)” removed; notes to entry 1 and 2 removed and a new note 1 to entry added.]

3.1.21

medicinal product identifier

MPID

identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed by a medicines regulatory agency in a region

[SOURCE:ISO 11615:2017, 3.1.53, — modified, “unique” removed; notes to entry removed.]

3.1.22

medicinal product package identifier

PCID

identifier allocated to a packaged medicinal product supplementary to any existing authorization number as ascribed by a medicines regulatory agency in a region

[SOURCE:ISO 11615:2017, 3.1.55, — modified, “unique” removed; note to entry removed.]

Note 1 to entry: See Annex D for relationship between MPID, PCID, and GTIN®.

3.1.23

object identifier

OID

globally unique value associated with an object to unambiguously identify it

3.1.24

outer packaging

external container in which a medicinal product is supplied

[SOURCE:ISO 11615:2017, 3.1.57 — modified, note to entry removed.]

Note 1 to entry: Corresponds frequently to “secondary packaging” (see Annex B).

3.1.25

packaging hierarchy

relationship between a medicinal product package and its grouping in larger/smaller quantities

Note 1 to entry: See Annex B for illustration of “primary packaging”, “secondary packaging”, etc.

3.1.26

packaged medicinal product

medicinal product in a container being part of a package, representing the entirety that has been packaged for sale or supply

[SOURCE:ISO 11615:2017, 3.1.59]

Note 1 to entry: Corresponds frequently to “primary packaging” (see Annex B).

3.1.27

pharmaceutical product

qualitative and quantitative composition of a medicinal product in the dose form approved for administration in line with the regulated product information

[SOURCE:ISO 11615:2017, 3.1.60]

3.1.28

pharmaceutical product identifier

PhPID

identifier for a pharmaceutical product

[SOURCE:ISO 11615:2017, 3.1.61 — modified, “unique” removed.]

3.1.29

pharmacovigilance

science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem

[SOURCE:WHO, Reporting and learning systems for medication errors: the role of pharmacovigilance centres, 2014, Annex 1]

3.1.30

radio frequency identification

RFID

wireless non-contact system that uses radio-frequency electromagnetic fields to transfer data from a tag attached to an object, for the purposes of automatic identification and tracking

3.1.31

serialization

assigning a unique identifier (e.g. a number) to an item (e.g. pack, case or pallet)

Note 1 to entry: This identifier is stored on a database along with other information about the item (e.g. manufacturer, batch info, etc). Serialization typically includes randomly selected, encrypted, numerical or alpha- numeric serial number.

Note 2 to entry: According to Reference [51], ‘unique identifier’ is the safety feature which enables the verification of the authenticity and the identification of an individual pack of a medicinal product.

3.1.32

traceability

ability to track forward the movement through specified stage(s) of the extended supply chain and trace backward the history, application, or location of that which is under consideration

[SOURCE:Global Traceability Standard for Healthcare, GS1, 2013, 5.2]

3.1.33

univocal coding

unique identifier

identification that is unique to a specific instance and cannot be confused with another identification

3.1.34

verification

reading unique identifier numbers and checking these in a database