SFS-EN ISO 11615:2017:en

Soveltamisala

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ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Message exchange format
5 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
6 Concepts required for the unique identification of Medicinal Products

6.1 General considerations
6.2 Authorised Medicinal Products
6.3 Investigational Medicinal Products
6.4 Concepts required for the unique identification of a Medicinal Product and the association with PhPID(s)
6.5 Concepts required for the unique identification of Medicinal Products and the association with the marketing authorisation number
6.6 Concepts required for the unique identification of Medicinal Products and the association with data carrier identifiers

7 Description of the information modelling principles and practices

7.1 General considerations
7.2 Conceptual overview diagrams
7.3 High-level diagrams
7.4 Detailed description diagrams

8 Identifying characteristics for authorised Medicinal Products

8.1 Primary identifiers — General considerations
8.2 Medicinal Product Identifier (MPID)
8.3 Packaged Medicinal Product Identifier (PCID)
8.4 Medicinal Product Batch Identifier (BAID1)
8.5 Medicinal Product Batch Identifier (BAID2)

9 Information for an authorised Medicinal Product

9.1 Authorised Medicinal Product — Information overview
9.2 Medicinal Product
9.3 Marketing authorisation
9.4 Organisation
9.5 Manufacturer/Establishment (organisation)
9.6 Packaged Medicinal Product, including manufactured item and device
9.7 Ingredient, substance and strength
9.8 Pharmaceutical product and device
9.9 Clinical particulars

10 Identifying characteristics for Investigational Medicinal Products

10.1 General
10.2 Primary identifiers
10.3 Investigational Medicinal Product Identifier (IMPID)
10.4 Investigational Medicinal Product Package Identifier (IPCID)
10.5 Investigational Medicinal Product Batch Identifier (BAID1)
10.6 Investigational Medicinal Product Batch Identifier (BAID2)

11 Information for an Investigational Medicinal Product

11.1 General
11.2 Conceptual overview of the information for an Investigational Medicinal Product
11.3 Investigational Medicinal Product
11.4 Clinical trial authorisation
11.5 Manufacturer/Establishment (organisation)
11.6 Investigational Packaged Medicinal Product
11.7 Pharmaceutical product
11.8 Ingredient
11.9 Clinical particulars
11.10 PhPID sets
11.11 Device nomenclature
11.12 Device batch identifier
11.13 Physical characteristics
11.14 Other characteristics

Annex A Full model — Authorised Medicinal Products detailed diagram (normative)
Annex B Full model — Investigational Medicinal Products detailed diagram (normative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Message exchange format
5 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications
6 Concepts required for the unique identification of Medicinal Products

6.1 General considerations
6.2 Authorised Medicinal Products
6.3 Investigational Medicinal Products
6.4 Concepts required for the unique identification of a Medicinal Product and the association with PhPID(s)
6.5 Concepts required for the unique identification of Medicinal Products and the association with the marketing authorisation number
6.6 Concepts required for the unique identification of Medicinal Products and the association with data carrier identifiers

7 Description of the information modelling principles and practices

7.1 General considerations
7.2 Conceptual overview diagrams
7.3 High-level diagrams
7.4 Detailed description diagrams

8 Identifying characteristics for authorised Medicinal Products

8.1 Primary identifiers — General considerations
8.2 Medicinal Product Identifier (MPID)
8.3 Packaged Medicinal Product Identifier (PCID)
8.4 Medicinal Product Batch Identifier (BAID1)
8.5 Medicinal Product Batch Identifier (BAID2)

9 Information for an authorised Medicinal Product

9.1 Authorised Medicinal Product — Information overview
9.2 Medicinal Product
9.3 Marketing authorisation
9.4 Organisation
9.5 Manufacturer/Establishment (organisation)
9.6 Packaged Medicinal Product, including manufactured item and device
9.7 Ingredient, substance and strength
9.8 Pharmaceutical product and device
9.9 Clinical particulars

10 Identifying characteristics for Investigational Medicinal Products

10.1 General
10.2 Primary identifiers
10.3 Investigational Medicinal Product Identifier (IMPID)
10.4 Investigational Medicinal Product Package Identifier (IPCID)
10.5 Investigational Medicinal Product Batch Identifier (BAID1)
10.6 Investigational Medicinal Product Batch Identifier (BAID2)

11 Information for an Investigational Medicinal Product

11.1 General
11.2 Conceptual overview of the information for an Investigational Medicinal Product
11.3 Investigational Medicinal Product
11.4 Clinical trial authorisation
11.5 Manufacturer/Establishment (organisation)
11.6 Investigational Packaged Medicinal Product
11.7 Pharmaceutical product
11.8 Ingredient
11.9 Clinical particulars
11.10 PhPID sets
11.11 Device nomenclature
11.12 Device batch identifier
11.13 Physical characteristics
11.14 Other characteristics

Annex A Full model — Authorised Medicinal Products detailed diagram (normative)
Annex B Full model — Investigational Medicinal Products detailed diagram (normative)

Bibliography

Tuoteryhmä(t)

35.240.80 Terveydenhuollon teknologian tietotekniset sovellukset »

Sidokset

Velvoittavat viittaukset

ISO 11238:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11239:2012 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 11240:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of units of measurement

ISO 11238:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11239:2012 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 11240:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of units of measurement
ISO 11616:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions -- Part 1: Country codes
ISO 639-1:2002 Codes for the representation of names of languages -- Part 1: Alpha-2 code
ISO 8601:2004 Data elements and interchange formats -- Information interchange -- Representation of dates and times
ISO/IEC 5218:2004
ISO/TS 19844:2016 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 20440:2016 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 20443:2017 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/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

Tekninen komitea

CEN/TC 251 Health informatics »

Vahvistuspäivä

15.12.2017

Julkaisupäivä

19.12.2017

Painos

2

Sivumäärä

92

Julkaisun kieli

englanti