ENV 12610:1997

Content
0. Foreword
    0.0 Mandate and Task Description
    0.1 Domain Description
    0.2 Structure of the document
    0.3 Users of the Prestandard
    0.4 Further developments
1. Scope
2. Normative References
3. Definitions (Normative)
4. Identifying Characteristics (Normative)
    4.0 Introduction
    4.1 Characteristics related to the ingredients
         4.1.0 Pharmaceutical class
         4.1.1 Ingredient designation
                4.1.1.0 Ingredient name
                4.1.1.1 Ingredient code value
         4.1.2 Ingredient manufacturer
         4.1.3 Ingredient batch number
         4.1.4 Ingredient description
         4.1.5 Ingredient territory
    4.2 Characteristics related to the pharmaceutical and the
         medicinal product
         4.2.0 Therapeutic group
         4.2.1 Medicinal product designation
                4.2.1.0 Medicinal product name
                4.2.1.1 Medicinal product code value
                4.2.1.2 Medicinal product name spoecifiers
         4.2.2 Marketing authorisation holder
         4.2.3 Marketing authorisation number
         4.2.4 Pharmaceutical product manufacturer
         4.2.5 Medicinal product manufacturer
         4.2.6 Strength
         4.2.7 Pharmaceutical form
         4.2.8 Dosage form
         4.2.9 Pharmaceutical product description
         4.2.10 Imprint
         4.2.11 Medicinal product batch number
         4.2.12 Pharmaceutical product batch number
         4.2.13 Medicinal product cluster
         4.2.14 Route of administration
         4.2.15 Medicinal product territory
    4.3 Characteristics related to the medicinal product
         packages
         4.3.0 Medicinal product package designation
         4.3.1 Medicinal product package responsible body
         4.3.2 Medicinal product package authorisation
                number
         4.3.3 Medicinal product package batch number
         4.3.4 Medicinal product package content
         4.3.5 Medicinal product package manufacturer
         4.3.6 Medicinal product package cluster
         4.3.7 Medicinal product package label
         4.3.8 Medicinal product package territory
    4.4 Overview of Identifying Concepts
5. Identifiers (Informative)
    5.0 Introduction
    5.1 Ingredient Identifiers
    5.2 Medicinal Product Identifiers
    5.3 Medicinal Product Package Identifiers
6. Conformity to the Standard
Annex A - List of Identifying Concepts
Annex B - List of Identifiers as proposed in this document
Annex C - Model Representation (Informative)
Annex D - Structure for a Concept System (Informative)
          D.0 Introduction
          D.1 Conceptual model at ingredient level
          D.2 Conceptual model at medicinal product level
          D.3 Conceptual model at medicinal package level
Annex E - Acronyms
Annex F - PT2-014 Team
Annex G - Index

The purpose of this European PreStandard is to define the semantic categories related to the identification of medicinal products and to establish a categorial structure that allows the description of the organization of the semantic categories representing the underlying system of characteristics.