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ISO 11239

ISO 11239 IDMP Standard lists regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging. The ISO 11239 standard identifies for example injection solution, injection suspension, infusion solution (or a less granular regional term linked to these. Differences in granularity between regional terminologies Many of the concepts covered in ISO 11239 […]

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ISO 11240

ISO 11240 – Units of Measurement What ISO 11240 does: specifies rules for the usage of units of measurement for IDMP specifies requirements for traceability to metrological standards establish reference code system for units provide structures and rules for mapping between different unit vocabularies and language translations linking to existing systems, dictionaries, and repositories Strength […]

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ISO 11615

ISO 11615 establishes definitions and concepts required for the detailed description and unique identification of medicinal products. The scope of ISO 11615 ISO 11615 describes data elements and regulated medicinal product information during their entire life cycle (development, authorisation, post-marketing and renewal or withdrawal from the market) and is composed of several ISO Standards. Taken […]

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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. […]

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Pharmacovigilance Implementing Measures

The Pharmacovigilance Implementing Measures, is the new pharmacovigilance legislation which came into effect in 2012. It introduced a range of new responsibilities for regulators and the pharmaceutical industry in the European Union (EU) concerning the Identification of Medicinal Products (IDMP). The activities introduced with the pharmacovigilance legislation fall into four main areas: Collection of key […]