While the ISO IDMP standards relate to human medicinal products, SPOR applies to both human and veterinary domains. lists of dosage forms, units of measurement and routes of administration. Referentials Management Service (RMS)- lists of terms (controlled vocabularies) to describe attributes of products, e.g.Organisation Management Service (OMS)- data comprising organisation name and location address, for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers.marketing authorisation, packaging and medicinal information) Product Management Service (PMS) - harmonised data and definitions to uniquely identify a medicinal product based on regulated information (e.g.Substance Management Service (SMS) - harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.The four SPOR services cover the four domains of SPOR master data:
The aim is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner. The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased programme, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data.ĮMA is delivering four SPOR data management services for the centralised management of master data that comply with the ISO IDMP standards. This content applies to human and veterinary medicines.
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