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DIN Standards Committee Quality Management, Statistics and Certification

Overview

This standard was developed in response to a worldwide demand for internationally harmonized specifications for medicinal products. It is one of five standards which together provide the basis for the unique identification of medicinal products. The group of standards comprises: - ISO 11615, Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information; - ISO 11616, Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information; - 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. The standards for the identification of medicinal products support the activities of medicines regulatory agencies worldwide. These activities include a variety of activities related to development, registration and life cycle management of medicinal products, as well as pharmacovigilance and risk management. To meet the primary objectives of the regulation of medicines and pharmacovigilance, it is necessary to reliably exchange medicinal product information in a robust and reliable manner. The IDMP standards therefore support the following interactions: - regulator to regulator, for example, the European Medicines Agency - U.S. Food and Drug Administration (FDA) or vice versa; - pharmaceutical company to regulator, for example, pharmaceutical company A - Health Canada; - sponsor of clinical trial to regulator, for example, university X - Austrian regulator; - regulator to other stakeholder, for example, Medicines Health Regulatory Agency (MHRA) - National Health System in Great Britain; - regulator to worldwide-maintained data sources, for example, Pharmaceutical and Medical Device Agency (PMDA) and allocation to a new substance identifier. The necessary messaging specifications are included as an integral part of the IDMP standards to secure these interactions. Unique identifiers produced in conformance with the IDMP standards are aimed to support applications where it is necessary to reliably identify and trace the use of medicinal products. There are many terms in use to describe basic concepts in the regulatory, pharmaceutical and healthcare standards development domain for different purposes and in different contexts. The terms and definitions given in this standard are to be applied for the concepts which are required to uniquely identify, characterize and exchange regulated medicinal products and associated information. The terms and definitions adopted in this standard are intended to facilitate the interpretation and application of legal and regulatory requirements but they are without prejudice to any legally binding document. In case of doubt or potential conflict, the terms and definitions contained in legally binding documents prevail. This part of the standard series specifies vocabularies for units of measurement. In the context of measurement terminology, currently there are several alternative approaches possible for expressing units of measurement that can be used in a given instance. It is therefore necessary to prepare a uniform standardized vocabulary that can be used as an international reference for: - unit concepts, - concept definitions, where applicable, and - concept identifiers. This standardized vocabulary needs to provide a mapping possibility taking into consideration the various approaches currently being applied. This helps to ensure that terms and identifiers currently used to represent units of measurement in the drug regulatory, pharmacovigilance and healthcare environments are mapped in a standardized and traceable way to the underlying metrological concepts. This will help ease implementation of this standard without impacting on the unit terms currently in use. The purpose of this standard is: a) to address the issues outlined above by connecting to existing unit vocabularies in current use, in particular the vocabulary used during the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); b) to facilitate electronic information exchange and interoperability that enables the unique and categorical identification of a medicinal product. Results of measurements are essential for the identification of medicinal products. However, often different ways are used to express these results. The situation is further complicated by differences in the ways they are expressed in national legislation and in local administration. From the many available conventions, a consensus shall therefore be reached on how to express the results of measurements on medicinal products, particularly for exchange between information systems. Universal principles for the expression of measurements have been specified by ISO/TC 12 in the ISO 31, ISO 1000 and recently in the ISO 80000 series of standards, which implement the International System of Units (SI) defined by the General Conference on Weights and Measures (GCPM). The implications of those standards are summarized in 4.2. Implementation of this standard ISO 11240 provides wider comprehension and interaction between countries and specialists in the field of medicinal product identification and pharmacovigilance. The committee responsible for this standard is NA 063-07-03 AA "Terminologie" ("Terminology") at DIN.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-02-03 AA - Terminology  

Responsible european committee

CEN/TC 251/WG 1 - Enterprise and Information