DIN EN ISO 11615:2013-03

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. In the context of exchange of regulatory information, the purpose of this standard is twofold: - to specify data elements, structures and relationships between the data elements which are required to uniquely and with certainty identify medicinal products for human use; - to specify definitions of terms for all data elements required to uniquely and with certainty identify medicinal products for human use. In addition, reference to the use of other normative IDMP and messaging standards for medicinal product information is included in this standard in order to support successful related information exchange. The committee responsible for this standard is NA 063-07-03 AA "Terminologie" ("Terminology") at DIN.