{
"description": "Identification of the prescribed product. Section A1.4 of the eHN guideline",
"_filename": "StructureDefinition-MedicinalProduct.json",
"package_name": "rs/hl7.fhir.eu.mpd",
"date": "2025-06-04T09:09:29+02:00",
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"name": "MedProductEhn",
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"copyright": "Used by permission of HL7 Europe, all rights reserved Creative Commons License",
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"experimental": null,
"resourceType": "StructureDefinition",
"title": "A1.4 Identification of the prescribed product",
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"short": "A.1.4.1 Name of the medicinal product",
"definition": "Brand name of the authorised medicinal product.\nIt has to be noted, that according to Implementing Directive 2012/52/EU additional requirements may apply.\n[not applicable for generic prescriptions]"
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"definition": "Identifier of a medicinal product refers to the product inside the package, not the packaged item as such. It could be MPID according to ISO 11615, EMA PMS ID and/or a national identifier.\n[not applicable for generic prescriptions]"
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"definition": "Identifier of a pharmaceutical product refers to unique PhPID according to ISO 11616. This could be a part of a description of a specific medicinal product or an attribute of a generic prescription.\n[not applicable for generic prescriptions]"
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"definition": "Identifier of a packaged medicinal product refers to a specific pack size of a specific product. It could be PCID according to ISO 11615 and/or its national equivalent.\n[not applicable for generic prescriptions]"
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"definition": "Organisation that holds the marketing authorisation of the prescribed product.\n[not applicable for generic prescriptions]"
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"definition": "All active substances according to ISO 11238. Referred to by \"\"common name\"\" in implementing directive 2012/52/EU.",
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"definition": "Presentation and/or concentration strength of the active substances. In addition, reference strength could be provided (Article 1 of Directive 2001/83/EC). Preferred codesystem UCUM and EDQM."
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"strength": "preferred",
"description": "EDQM"
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"short": "A.1.4.8 Package type",
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"binding": {
"strength": "preferred",
"description": "EDQM"
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"definition": "Typically, the pack size is the number of unit of presentations in the package. \nIt could also be presented using units of measurement (ml, g). In some cases, there is a need to refine the package size that it describes the amounts of different manufactured items in more than one inner packages. However, the overall amount of a prescribed product must be calculable from the pack size description.\n - Preferred system(s): UCUM; EDQM",
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"binding": {
"strength": "preferred",
"description": "UCUM, EDQM"
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"definition": "Identification of the prescribed product. Section A1.4 of the eHN guideline"
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"short": "A.1.4.3 Marketing authorisation holder",
"definition": "Organisation that holds the marketing authorisation of the prescribed product.\n[not applicable for generic prescriptions]"
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"description": "EMA SMS"
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"path": "MedicinalProduct.strength",
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"description": "ATC"
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"strength": "preferred",
"description": "EDQM"
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