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ISO 11238

Regulated information on substances (ISO 11238) ISO 11238 defines substances by their main, general characteristics and Specified Substances (which are more granular, specific descriptions of a substance, e.g. including manufaturing information, purity, grade). Substances can have different roles in medicinal products (e.g. active, adjuvant). They are identified via their molecular weight, structure and their unique […]


ISO 11616

ISO 11616 International Standard “Health informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information”. ISO 11616 is intended to assist pharmaceutical companies, medicines regulatory authorities and all other interested parties in implementing systems and constructing transmittable messages pertaining to pharmaceutical product identification. […]