regulated document
- Guideline or reference source
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- Definition
- document issued by a medicines regulatory authority in the context of an authorized medicinal product or an investigational medicinal product EXAMPLES Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL).
- Broader Term
- document
- Narrower Term
- summary of product characteristics
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