scope:

The purpose of this European standard 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 organisation of the semantic categories representing the underlying system of characteristics. The domain of this standard contains all medicinal products in the extended meaning of their characteristics as defined in Clause 3 and 5 of this document. Each time the term "drug" is used in this document, it should be interpreted as equivalent to the concept "medicinal product". The domain of this standard has not been limited to the identification of medicinal products in a clinical environment, but also includes the identification of medicinal products at production level, at marketing level (e.g. stock management, dispensing), in research (e.g. medicinal product event and outcome analysis), or for example, in the production and maintenance of medicinal product databases. Non-identifying characteristics of a medicinal product, or characteristics related to the prescription or administration of medicinal products, and other characteristics related to the use (effect and outcome) of medicinal products, are outside the scope of this standard. The development of a (new) classification or coding system for medicinal products or medicinal product related terms is outside the scope of this standard, as is any proposal to adopt an existing classification or coding system. The definition of the rules which production, labelling, and packaging of medicinal products have to comply to in order to conform to national or European regulations is outside the scope of this standard. The definition of the requirements to be fulfilled by ingredients, medicinal products and medicinal product packages in order to comply to European and National regulations is outside the scope of this standard.