This Technical Specification specifies the business requirements for the structured content of structured or semi-structured 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. Comprehension of dose instructions by the patient is an overarching consideration for patient safety and the best patient outcomes. Related factors are discussed, but are not part of the primary scope. This Technical Specification 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 Technical Specification are: — 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: — wide range of knowledge about medicines that would be handled in drug knowledge databases and decision support systems; — the complete medical record (EHR); — a medicinal product dictionary.