This document specifies the business requirements for the structured content of structured or semistructured dose instructions for recording dose instructions in the electronic health record (EHR), supporting clinical decision support, and in exchanging medication orders, as applicable to primary, secondary and tertiary care. This document is focused on the dose instructions as will be presented to the individual subject of care or caregiver. Comprehension of dose instructions by the subject of care or caregiver is an overarching consideration for subject of care safety and the best outcomes. Related factors are discussed but are not part of the primary scope. This document does not define an information model, except to the extent that those information model concepts are necessary to define business requirements. Outside the scope of this document are: – The implementation of dose instructions, i.e. assembling the structured elements into a form appropriate for the patient or caregiver; – The content of a medication order (see ISO 17523) beyond content related to dose instructions; – The content of a record of dispense of a medicinal product (see ISO/TS 19293); – The functionality of health, clinical and/or pharmacy systems; – Other kinds of content of health, clinical or pharmacy systems that are needed to support the whole process of health care providers, such as: – A drug knowledge database (see ISO/TS 22756); – A decision support system (see ISO/TS 22756 and ISO/TS 22703); – A complete medical record (EHR); – A medicinal product dictionary (see ISO/TS 19256);