NF EN ISO 11615

NF EN ISO 11615

February 2013
Standard Cancelled

Health Informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information

ISO 11615:2012 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.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

February 2013

Number of pages

129 p.

Reference

NF EN ISO 11615

ICS Codes

35.240.80   IT applications in health care technology

Classification index

S95-615

Print number

1

International kinship

ISO 11615:2012

European kinship

EN ISO 11615:2012
Sumary
Health Informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information

ISO 11615:2012 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.

Standard replaced by (1)
NF EN ISO 11615
February 2018
Standard Current
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information

<p>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.</p> <p>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.</p> <p>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.</p>

Table of contents
View the extract
  • Avant-propos
    v
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes, définitions et abréviations
    1
  • 3.1 Termes et définitions
    1
  • 3.2 Abréviations
    12
  • 4 Exigences
    14
  • 4.1 Concepts requis pour l'identification unique de médicaments
    14
  • 5 Description des principes et des pratiques de modélisation des informations
    17
  • 5.1 Considérations générales
    17
  • 5.2 Diagrammes d'aperçu conceptuel
    18
  • 5.3 Diagrammes de niveau élevé pour des paragraphes
    18
  • 5.4 Diagrammes de descriptions détaillées
    19
  • 6 Caractéristiques d'identification pour les médicaments autorisés
    22
  • 6.1 Identifiants primaires
    22
  • 6.2 Identifiant de médicament (MPID)
    22
  • 6.3 Identifiant de médicament emballé (PCID)
    23
  • 6.4 Identifiant de lot de médicament (BAID_1)
    24
  • 6.5 Identifiant de lot de médicament (BAID_2)
    24
  • 7 Informations concernant un médicament autorisé
    24
  • 7.1 Médicament autorisé - Aperçu des informations
    24
  • 7.2 Médicament
    26
  • 7.3 Autorisation de mise sur le marché
    32
  • 7.4 Organisme
    37
  • 7.5 Fabricant/établissement
    39
  • 7.6 Médicament emballé, comprenant un élément fabriqué et un dispositif
    40
  • 7.7 Ingrédient, substance et dosage
    49
  • 7.8 Produit pharmaceutique et dispositif
    53
  • 7.9 Particularités cliniques
    57
  • 8 Caractéristiques d'identification pour médicaments de recherche
    64
  • 8.1 Généralités
    64
  • 8.2 Identifiants primaires
    64
  • 8.3 Identifiant de médicament de recherche (IMPID)
    65
  • 8.4 Identifiant d'emballage de médicament de recherche (IPCID)
    66
  • 8.5 Identifiant de lot de médicament de recherche (IBAID_1)
    66
  • 8.6 Identifiant de lot de médicament de recherche (IBAID_2)
    67
  • 9 Informations concernant un médicament de recherche
    67
  • 9.1 Aperçu conceptuel des informations concernant un Médicament de recherche
    67
  • 9.2 Médicament de recherche
    69
  • 9.3 Autorisation d'essai clinique
    72
  • 9.4 Fabricant/établissement
    75
  • 9.5 Médicament de recherche emballé
    75
  • 9.6 Produit pharmaceutique
    75
  • 9.7 Ingrédient
    77
  • 9.8 Particularités cliniques
    77
  • Annexe A (informative) Modèle complet - Niveau conceptuel des médicaments autorisés
    78
  • Annexe B (informative) Modèle complet - Diagramme détaillé des médicaments autorisés
    79
  • Annexe C (informative) Modèle complet - Niveau conceptuel des médicaments de recherche
    80
  • Annexe D (informative) Modèle complet - Diagramme détaillé des médicaments de recherche
    81
  • Annexe E (informative) Exemple pratique sous forme de tableau
    82
  • Annexe F (informative) Inventaire des classes et attributs
    92
  • Annexe G (informative) Exemples de mise en oeuvre d'informations relatives à un médicament
    107
  • Bibliographie
    115
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ