ISO 11616:2017 pdf free

ISO 11616:2017 pdf free.Health informatics – Identification of medicinal products
any pharmaceutical product (3.1.24) or combination of pharmaceutical products that may be administered to human beings (or animals) for treating or preventing disease, with the aim/ purpose of making a medical diagnosis or to restore, correct or modify physiological functions
Note 1 to entry: A Medicinal Product may contain in the packaging one or more manufactured items (3.1.17) and one or more pharmaceutical products. In certain regions (3.1.31), a Medicinal Product may also be defined as any substance (3.1.35) or combination of substances which may be used to make a medical diagnosis. The provisions in this document apply to proprietary Medicinal Products for human use intended to be placed on the market and to industrially manufactured Medicinal Products, the marketing of which has been authorised by a medicines regulatory agency (3.1.22). However, the provisions do not apply to: i) Medicinal Products prepared according to prescription (e.g. prepared in a pharmacy from a prescription intended for a specific patient), i) Medicinal Products prepared in accordance with an official formula (e.g. prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy), ii) Medicinal Products intended for research and development trials, and iv) intermediate products intended for subsequent processing by an authorised manufacturer.
amount of substance (3.1.35) and specified substance (3.1.32) constituents of the investigational or authorised Medicinal Product (3.1.19) expressed in a ratio scale
Note 1 to entry: It is necessary for the quantitative composition of the substance(s) or the specified substance descriptions of the finished investigational or authorised Medicinal Products depending on the pharmaceutical form concerned) to specify the mass, or the number of units of biological activity, either per dosage unit or per unit of mass or volume, of each substance or specified substance. Substance or specified substance descriptions present in the form of compounds or derivatives are always designated quantitatively by their total mass and, if necessary or relevant, by the mass of active entity, or entities, of the molecule. The term strength is a synonym of quantitative composition.ISO 11616 pdf download.