Release 4B R5 Final QA

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0-draft-final: Final QA Preview for R5 - STU see ballot notes ). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

Regulatedauthorization.profile.xml

Example StructureDefinition/RegulatedAuthorization (XML)

Biomedical Research and Regulation Work Group Maturity Level : N/A Standards Status : Informative Compartments : Not linked to any defined compartments

Raw XML ( canonical form + also see XML Format Specification )

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StructureDefinition for regulatedauthorization

<?xml version="1.0" encoding="UTF-8"?> vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCs PVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAACCE lEQVQ4y4XTv2sUQRTA8e9Mzt3kjoOLSXFgZ6GJQlALCysLC89OsLTXv0VFxE4stRAEQUghSWEXuM4qMZpATsUD70dyMdnduZ15z2I vMV5IfDDNm5nPm59GVTkpms1mTVXvhxDuichlEZn03m+KyJL3/mWj0fiKqp7YVlZWXrfbbR2PTqeji4uLn1WVEqdECKFRr9eP5Wdn Z/HeXwROB0TEA3S7XarVKiLC1tYW8/PzeO/5LxBCUABrLXEc02q1KJfLB30F0P144dPU9LVL1kwcrU06WP0ewhML4JwDYDgcHo7I8 7wAjNq5ypU3Z8arT8F5u/xejw52zmGM+Rcg1wyIcc/BTYCdBlODyh3ElA1AHMekaUoURURRBECWZSNgaGzBxxAU9jfQ9jrJr2dcbb XobRYHlQAzo9X1gDR9+KUArE6CwLefZD9WCW6P0uRZKreXqADkHXZ3dshzjwRholJH397AOXcTwHTfzQ1n7q6NnYEAy+DWQVNwKWQ J6vcx557Se7HAzIN1M9rCwVteA/rAYDRRICQgSZEr7WLYO3bzJVJGQBu0D74PkoHkoBnIHvjfkO9AGABmDHCjFWgH8i7kPQh9yEeY H4DfLhBJgA2A7BBQJ9uwXWY3rhJqFo1AaiB1CBngwKZQcqAeSFSduL9Akj7qPF64jnALS5VTPwdgPwwJ+uog9Qcx4kRZiPKqxgAAA ABJRU5ErkJggg== RegulatedAuthorization : Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product. vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold; color: black; background-color: #fff5e6 vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxRegulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product Elements defined in Ancestors: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes., The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource., A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc., , A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety., These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope., May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension., May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6E EQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7 RegulatedAuthorization.identifier : Business identifier for the authorization, typically assigned by the authorizing body. vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxBusiness identifier for the authorization, typically assigned by the authorizing body vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCs PVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC RegulatedAuthorization.subject : The product type, treatment, facility or activity that is being authorized. vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px ( | | | | | | | | | | | | ) vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxThe product type, treatment, facility or activity that is being authorized vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6E EQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7 RegulatedAuthorization.type : Overall type of this authorization, for example drug marketing approval, orphan drug designation. vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxOverall type of this authorization, for example drug marketing approval, orphan drug designation ( Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.) vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCs PVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARk lEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvT RgwAAAABJRU5ErkJggg== vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6E EQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7 RegulatedAuthorization.region : The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted. vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxThe territory in which the authorization has been granted ( Instances are not expected or even encouraged to draw from the specified value set. 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Intermediate states and actions can be tracked with cases and applications. vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxThe status that is authorised e.g. approved. 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As an example, a Marketing Authorization includes the date of authorization and/or an expiration date. vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxThe time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6E EQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC RegulatedAuthorization.indication : Condition for which the use of the regulated product applies. vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px ( ) vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCs PVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7 RegulatedAuthorization.intendedUse : The intended use of the product, e.g. prevention, treatment, diagnosis. vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxThe intended use of the product, e.g. prevention, treatment ( Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant.) vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6E EQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7 RegulatedAuthorization.basis : The legal or regulatory framework against which this authorization is granted, or other reasons for it. vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxThe legal/regulatory framework or reasons under which this authorization is granted ( Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.) vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCs PVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC RegulatedAuthorization.holder : The organization that has been granted this authorization, by some authoritative body (the 'regulator'). vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px ( ) vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6E EQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC RegulatedAuthorization.regulator : The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc. vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px ( ) vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAI0lEQVR42u3QIQEAAAACIL/6/4MvTAQOkLYBAAB4kAAAANwMad9AqkRjgNAAAAA ASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUOL +O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC data:image/png;base64,R0lGODlhEAAQAPQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPzurPvuw/ npofbjquvNefHVduuyN+uuMu3Oafbgjfnqvf/3zv/3xevPi+vRjP/20/bmsP///wD/ACH5BAEKAB8ALAAAAAAQABAAAAVl4CeOZGm e5qCqqDg8jyVJaz1876DsmAQAgqDgltspMEhMJoMZ4iy6I1AooFCIv+wKybziALVAoAEjYLwDgGIpJhMslgxaLR4/3rMAWoBp32V5 exg8Shl1ckRUQVaMVkQ2kCstKCEAOw== RegulatedAuthorization.case : The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page). vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxThe case or regulatory procedure for granting or amending a regulated authorization. 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text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxThe status associated with the case ( Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant.) vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALElEQVR42u3QwQkAMAwDsezq/WdIO4XJQwa9DTdJpulv258AAMANIgAAADUPYAV AgAJ//usAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIZgEiYEgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAIElEQVQ4y2P8//8/AyWAiYF CMGrAqAGjBowaMGoAAgAALL0DKYQ0DPIAAAAASUVORK5CYII= data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC data:image/png;base64,R0lGODlhEAAQAMQfAGm6/idTd4yTmF+v8Xa37KvW+lyh3KHJ62aq41ee2bXZ98nm/2mt5W2Ck5XN/C 1chEZieho8WXXA/2Gn4P39/W+y6V+l3qjP8Njt/lx2izxPYGyv51Oa1EJWZ////////yH5BAEAAB8ALAAAAAAQABAAAAWH4Cd+Xml 6Y0pCQts0EKp6GbYshaM/skhjhCChUmFIeL4OsHIxXRAISQTl6SgIG8+FgfBMoh2qtbLZQr0TQJhk3TC4pYPBApiyFVDEwSOf18UF XxMWBoUJBn9sDgmDewcJCRyJJBoEkRyYmAABPZQEAAOhA5seFDMaDw8BAQ9TpiokJyWwtLUhADs= vertical-align: top; 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If hours and minutes are specified, a time zone SHALL be populated. The format is a union of the schema types gYear, gYearMonth, date and dateTime. Seconds must be provided due to schema type constraints but may be zero-filled and may be ignored. Dates SHALL be valid dates. vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAI0lEQVR42u3QIQEAAAACIL/6/4MvTAQOkLYBAAB4kAAAANwMad9AqkRj gNAAAAAASUVORK5CYII=) data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg== data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIZgEiYEgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAIElEQVQ4y2P8//8/AyWAiYF CMGrAqAGjBowaMGoAAgAALL0DKYQ0DPIAAAAASUVORK5CYII= data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUOL +O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABGdBTUEAAK/INwWK6QAAABl0RVh0U2 9mdHdhcmUAQWRvYmUgSW1hZ2VSZWFkeXHJZTwAAAKjSURBVDjLrZLdT1JhHMfd6q6L7voT3NrEuQq6aTircWFQ04u4MetCZ4UXGY2 J1UoMdCoWxMZWDWtrrqHgylZ54RbkZtkiJ5aAku8MXXqQl3PgAOfb8xwq5LrOzmfnd34vn+d5tqcMQNm/UPZfBMHXx2ZWvI386odL e7jIL7w5EQ68qjhEOFjCmMj+v4LQmCwtCHkSCuSlFOIst4X1KU1mbUqT/kPki57bmL6xEnx55HxRMCqNCTkO6fUBpH5YkFoeBLsyA iHLEFcSQi5B2C38Z3eAPJ8JjcrmigKnLJ7nd8mwDcnFh4h/68T29FVsfW4F4zeCmb0LZqYDO191hOtkZ5sIuY8lioJhKZ9lo2DmbN jx9WDTowW7+YmsGv+9Ov3GijsgxwsNy7iiYOg4L54/nyawQC4lDubYANIRG7g1I9glHVILl5EMNCCXnEfouXSP4JksI+RY5OIfkWX Gwf8cQSb6hAz2gV2+BXaxFangBSS/n0PCfxq5xAxCg3sFj2TpPB8Hvz2G3dWneOvqhLnPCIfDgd5uPebfNyAyrUR/t1bMmft7MdR1 NiuXyw8UBDYpJ/AMkhsOPLa2wmKxIBqNIhwOw+Px4EG/Hvb7GoSCc2JucnJS7FEqlb2FizRwNMLHFmPvXnQJN/U6+Px+3LvdApVKi ebmZlitVuj1ejFWqc7AZNCJEq1WGxMFAVPFtUCPZKhDXZUyGu6IAr+pklOclGNiYgI+nw9erxculws0N2uqjFOBwWDgSu61RCK50t LSwlBBfX39eE1NDa9QKFBXVydCY5qjNSqgvSWCw+RRqVTzZrOZcTqd2263G3a7HW1tbWhvbxdjmqM12kN7SwTl5eX7qqurq2pra5e ampqSGo2GI2TUanUj4RSJ4zRHa7SH9v4C8Nrl+GFh7LoAAAAASUVORK5CYII= RegulatedAuthorization.case.application : A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process. vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxsee vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4pxApplications submitted to obtain a regulated authorization. Steps within the longer running case or procedure Documentation for this format Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product. Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product. If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descenda nts().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f:refere nce/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))])) If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time. The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded information is added later. These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefi nition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorizat ion or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) not(f:Citation|f:Evidence|f:EvidenceReport|f:EvidenceVariable|f:MedicinalProductDefinition|f:Package dProductDefinition|f:AdministrableProductDefinition|f:Ingredient|f:ClinicalUseDefinition|f:RegulatedA uthorization|f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic) or not(parent::f:Citatio n|parent::f:Evidence|parent::f:EvidenceReport|parent::f:EvidenceVariable|parent::f:MedicinalProductDe finition|parent::f:PackagedProductDefinition|parent::f:AdministrableProductDefinition|parent::f:Ingre dient|parent::f:ClinicalUseDefinition|parent::f:RegulatedAuthorization|parent::f:SubstanceDefinition| f:SubscriptionStatus|f:SubscriptionTopic) May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.ht ml#modifierExtension). Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications. The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date. Marketing Authorisation.Validity Period Start, Marketing Authorisation.Validity Period End The legal or regulatory framework against which this authorization is granted, or other reasons for it. A legal or regulatory framework against which an authorization is granted, or other reasons for it. The organization that has been granted this authorization, by some authoritative body (the 'regulator'). The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc. The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page). Marketing Authorisation.Marketing Authorisation Procedure, Marketing Authorisation Procedure.Marketi ng Authorisation Application Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.ht ml#modifierExtension). Modifier extensions are expected to modify the meaning or interpretation of the element that contains them Marketing Authorisation Procedure.Procedure Identifier / Number, Marketing Authorisation Application.Application Identifier / Number Marketing Authorisation Procedure.Procedure Type, Marketing Authorisation Application.Application Type Marketing Authorisation Procedure.Procedure Date Start, Marketing Authorisation Procedure.Procedure Date End, Marketing Authorisation Application.Application Date Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process. Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product. The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications. The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date. Marketing Authorisation.Validity Period Start, Marketing Authorisation.Validity Period End The legal or regulatory framework against which this authorization is granted, or other reasons for it. A legal or regulatory framework against which an authorization is granted, or other reasons for it. The organization that has been granted this authorization, by some authoritative body (the 'regulator'). The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc. The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page). Marketing Authorisation.Marketing Authorisation Procedure, Marketing Authorisation Procedure.Marketi ng Authorisation Application Marketing Authorisation Procedure.Procedure Identifier / Number, Marketing Authorisation Application.Application Identifier / Number Marketing Authorisation Procedure.Procedure Type, Marketing Authorisation Application.Application Type Marketing Authorisation Procedure.Procedure Date Start, Marketing Authorisation Procedure.Procedure Date End, Marketing Authorisation Application.Application Date Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process. 
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<StructureDefinition xmlns="http://hl7.org/fhir">  <id value="RegulatedAuthorization"/>   <meta>     <lastUpdated value="2023-03-01T23:03:57.298+11:00"/>   </meta>   <text>     <status value="generated"/>     <div xmlns="http://www.w3.org/1999/xhtml">      <table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align:
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            <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a>           </th>           <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a>           </th>           <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpw
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            <span title="RegulatedAuthorization : Regulatory approval, clearance or licencing related to
             a regulated product, treatment, facility or activity that is cited in a guidance,
             regulation, rule or legislative act. An example is Market Authorization relating
             to a Medicinal Product.">RegulatedAuthorization</span> 
            <a name="RegulatedAuthorization"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="versions.html#std-process" style="padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold;
             color: black; background-color: #fff5e6" title="Standards Status = Trial Use">TU</a> 
          </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px"/> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="domainresource.html">DomainResource</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Regulatory approval, clearance or licencing related to a regulated product, treatment,
             facility or activity e.g. Market Authorization for a Medicinal Product
            <br/>              <br/>  Elements defined in Ancestors:             <a href="resource.html#Resource" title="The logical id of the resource, as used in the URL for the resource. Once assigned,
             this value never changes.">id</a> , 
            <a href="resource.html#Resource" title="The metadata about the resource. This is content that is maintained by the infrastructure.
             Changes to the content might not always be associated with version changes to the
             resource.">meta</a> , 
            <a href="resource.html#Resource" title="A reference to a set of rules that were followed when the resource was constructed,
             and which must be understood when processing the content. Often, this is a reference
             to an implementation guide that defines the special rules along with other profiles
             etc.">implicitRules</a> , 
            <a href="resource.html#Resource" title="The base language in which the resource is written.">language</a> ,             <a href="domainresource.html#DomainResource" title="A human-readable narrative that contains a summary of the resource and can be used
             to represent the content of the resource to a human. The narrative need not encode
             all the structured data, but is required to contain sufficient detail to make it
             &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions
             may define what content should be represented in the narrative to ensure clinical
             safety.">text</a> , 
            <a href="domainresource.html#DomainResource" title="These resources do not have an independent existence apart from the resource that
             contains them - they cannot be identified independently, nor can they have their
             own independent transaction scope. This is allowed to be a Parameters resource
             if and only if it is referenced by a resource that provides context/meaning.">contained</a> , 
            <a href="domainresource.html#DomainResource" title="May be used to represent additional information that is not part of the basic definition
             of the resource. To make the use of extensions safe and managable, there is a strict
             set of governance applied to the definition and use of extensions. Though any implementer
             can define an extension, there is a set of requirements that SHALL be met as part
             of the definition of the extension.">extension</a> , 
            <a href="domainresource.html#DomainResource" title="May be used to represent additional information that is not part of the basic definition
             of the resource and that modifies the understanding of the element that contains
             it and/or the understanding of the containing element's descendants. Usually modifier
             elements provide negation or qualification. To make the use of extensions safe
             and managable, there is a strict set of governance applied to the definition and
             use of extensions. Though any implementer is allowed to define an extension, there
             is a set of requirements that SHALL be met as part of the definition of the extension.
             Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or
             DomainResource (including cannot change the meaning of modifierExtension itself).">modifierExtension</a> 
          </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         #F7F7F7">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
           url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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            oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/>  
            <span title="RegulatedAuthorization.identifier : Business identifier for the authorization,
             typically assigned by the authorizing body.">identifier</span> 
            <a name="RegulatedAuthorization.identifier"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#Identifier">Identifier</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">Business identifier for the authorization, typically assigned by the authorizing
             body
            <br/>              <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
          e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
          9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
            YAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI1
            2P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> 
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            +2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> 
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
            BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAA
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            6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/>  
            <span title="RegulatedAuthorization.subject : The product type, treatment, facility or activity
             that is being authorized.">subject</span> 
            <a name="RegulatedAuthorization.subject"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="references.html#Reference">Reference</a> (            <a href="medicinalproductdefinition.html">MedicinalProductDefinition</a>  |             <a href="biologicallyderivedproduct.html">BiologicallyDerivedProduct</a>  |             <a href="nutritionproduct.html">NutritionProduct</a>  |             <a href="packagedproductdefinition.html">PackagedProductDefinition</a>  |             <a href="manufactureditemdefinition.html">ManufacturedItemDefinition</a>  |             <a href="ingredient.html">Ingredient</a>  |             <a href="substancedefinition.html">SubstanceDefinition</a>  |             <a href="devicedefinition.html">DeviceDefinition</a>  |             <a href="researchstudy.html">ResearchStudy</a>  |             <a href="activitydefinition.html">ActivityDefinition</a>  |             <a href="plandefinition.html">PlanDefinition</a>  |             <a href="observationdefinition.html">ObservationDefinition</a>  |             <a href="practitioner.html">Practitioner</a>  |             <a href="organization.html">Organization</a>  |             <a href="location.html">Location</a> )          </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">The product type, treatment, facility or activity that is being authorized
            <br/>              <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         #F7F7F7">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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           url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
          EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            2P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> 
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
            YAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y
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            <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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            oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/>  
            <span title="RegulatedAuthorization.type : Overall type of this authorization, for example drug
             marketing approval, orphan drug designation.">type</span> 
            <a name="RegulatedAuthorization.type"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">Overall type of this authorization, for example drug marketing approval, orphan
             drug designation
            <br/>  Binding:             <a href="valueset-regulated-authorization-type.html">Regulated Authorization Type</a>  (            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
             set.  The value set merely provides examples of the types of concepts intended
             to be included.">Example</a> )
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
          e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
          9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            2P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> 
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
            YAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpw
            YAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyj
            uYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==" style="background-color: white; background-color: inherit" title="Primitive Data Type"/>  
            <span title="RegulatedAuthorization.description : General textual supporting information.">description</span>             <a name="RegulatedAuthorization.description"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#markdown">markdown</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">General textual supporting information
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         #F7F7F7">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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            Slfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8AL
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            oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/>  
            <span title="RegulatedAuthorization.region : The territory (e.g., country, jurisdiction etc.)
             in which the authorization has been granted.">region</span> 
            <a name="RegulatedAuthorization.region"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">The territory in which the authorization has been granted
            <br/>  Binding:             <a href="valueset-jurisdiction.html">Jurisdiction ValueSet</a>  (            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
             set.  The value set merely provides examples of the types of concepts intended
             to be included.">Example</a> )
            <br/>              <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
          e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
          9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
            YAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI1
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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            oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: white; background-color: inherit" title="Data Type"/>  
            <span title="RegulatedAuthorization.status : The status that is authorised e.g. approved. Intermediate
             states and actions can be tracked with cases and applications.">status</span> 
            <a name="RegulatedAuthorization.status"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">The status that is authorised e.g. approved. Intermediate states can be tracked
             with cases and applications
            <br/>  Binding:             <a href="valueset-publication-status.html">PublicationStatus</a>  (            <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability
             purposes but are not required to do so to be considered conformant.">Preferred</a> )
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         #F7F7F7">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
           url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
          EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpw
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            <span title="RegulatedAuthorization.statusDate : The date at which the current status was assigned.">statusDate</span>             <a name="RegulatedAuthorization.statusDate"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#dateTime">dateTime</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">The date at which the current status was assigned
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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            <span title="RegulatedAuthorization.validityPeriod : The time period in which the regulatory
             approval, clearance or licencing is in effect. As an example, a Marketing Authorization
             includes the date of authorization and/or an expiration date.">validityPeriod</span> 
            <a name="RegulatedAuthorization.validityPeriod"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#Period">Period</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">The time period in which the regulatory approval etc. is in effect, e.g. a Marketing
             Authorization includes the date of authorization and/or expiration date
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         #F7F7F7">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
           url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
            BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAA
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            <span title="RegulatedAuthorization.indication : Condition for which the use of the regulated
             product applies.">indication</span> 
            <a name="RegulatedAuthorization.indication"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="references.html#CodeableReference">CodeableReference</a> (            <a href="clinicalusedefinition.html">ClinicalUseDefinition</a> )          </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">Condition for which the use of the regulated product applies
            <br/>              <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
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          9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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            PbPgrqZW+/QlPz48K2EMv36866OUPvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/L
            Slfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8AL
            AAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYwbdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY
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            oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: white; background-color: inherit" title="Data Type"/>  
            <span title="RegulatedAuthorization.intendedUse : The intended use of the product, e.g. prevention,
             treatment, diagnosis.">intendedUse</span> 
            <a name="RegulatedAuthorization.intendedUse"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">The intended use of the product, e.g. prevention, treatment
            <br/>  Binding:             <a href="valueset-product-intended-use.html">Product Intended Use</a>  (            <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability
             purposes but are not required to do so to be considered conformant.">Preferred</a> )
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         #F7F7F7">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
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          EwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcS
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            PbPgrqZW+/QlPz48K2EMv36866OUPvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/L
            Slfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8AL
            AAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYwbdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY
            5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSFVResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuq
            oTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/>  
            <span title="RegulatedAuthorization.basis : The legal or regulatory framework against which
             this authorization is granted, or other reasons for it.">basis</span> 
            <a name="RegulatedAuthorization.basis"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#CodeableConcept">CodeableConcept</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">The legal/regulatory framework or reasons under which this authorization is granted
            <br/>  Binding:             <a href="valueset-regulated-authorization-basis.html">Regulated Authorization Basis</a>  (            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
             set.  The value set merely provides examples of the types of concepts intended
             to be included.">Example</a> )
            <br/>              <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;bas
          e64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj
          9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)">
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            2P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> 
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            +2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> 
            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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            FxJREFUOE/NjEEOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG
            6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/>  
            <span title="RegulatedAuthorization.holder : The organization that has been granted this authorization,
             by some authoritative body (the 'regulator').">holder</span> 
            <a name="RegulatedAuthorization.holder"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="references.html#Reference">Reference</a> (            <a href="organization.html">Organization</a> )          </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">The organization that has been granted this authorization, by the regulator
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         #F7F7F7">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image:
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1
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            <span title="RegulatedAuthorization.regulator : The regulatory authority or authorizing body
             granting the authorization. For example, European Medicines Agency (EMA), Food
             and Drug Administration (FDA), Health Canada (HC), etc.">regulator</span> 
            <a name="RegulatedAuthorization.regulator"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">
            <a href="references.html#Reference">Reference</a> (            <a href="organization.html">Organization</a> )          </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">The regulatory authority or authorizing body granting the authorization
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
         white">
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <span title="RegulatedAuthorization.attachedDocument : Additional information or supporting
             documentation about the authorization.">attachedDocument</span> 
            <a name="RegulatedAuthorization.attachedDocument"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="references.html#Reference">Reference</a> (            <a href="documentreference.html">DocumentReference</a> )          </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <br/>              <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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            <span title="RegulatedAuthorization.case : The case or regulatory procedure for granting or
             amending a regulated authorization. An authorization is granted in response to
             submissions/applications by those seeking authorization. A case is the administrative
             process that deals with the application(s) that relate to this and assesses them.
             Note: This area is subject to ongoing review and the workgroup is seeking implementer
             feedback on its use (see link at bottom of page).">case</span> 
            <a name="RegulatedAuthorization.case"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <a href="types.html#BackBoneElement">BackboneElement</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">The case or regulatory procedure for granting or amending a regulated authorization.
             Note: This area is subject to ongoing review and the workgroup is seeking implementer
             feedback on its use (see link at bottom of page)
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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            <span title="RegulatedAuthorization.case.identifier : Identifier by which this case can be referenced.">identifier</span>             <a name="RegulatedAuthorization.case.identifier"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..1</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">
            <a href="datatypes.html#Identifier">Identifier</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Identifier by which this case can be referenced
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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            <span title="RegulatedAuthorization.case.type : The defining type of case.">type</span>             <a name="RegulatedAuthorization.case.type"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <a href="datatypes.html#CodeableConcept">CodeableConcept</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
           #F0F0F0 solid; padding:0px 4px 0px 4px">The defining type of case
            <br/>  Binding:             <a href="valueset-regulated-authorization-case-type.html">Regulated Authorization Case Type</a>  (            <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value
             set.  The value set merely provides examples of the types of concepts intended
             to be included.">Example</a> )
            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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            <span title="RegulatedAuthorization.case.status : The status associated with the case.">status</span>             <a name="RegulatedAuthorization.case.status"> </a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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           solid; padding:0px 4px 0px 4px">The status associated with the case
            <br/>  Binding:             <a href="valueset-publication-status.html">PublicationStatus</a>  (            <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability
             purposes but are not required to do so to be considered conformant.">Preferred</a> )
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px
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            <br/>            </td>         </tr>         <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color:
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
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            <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpw
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                        Dates SHALL be valid dates.">dateDateTime</span> 
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            <span title="RegulatedAuthorization.case.application : A regulatory submission from an organization
             to a regulator, as part of an assessing case. Multiple applications may occur over
             time, with more or different information to support or modify the submission or
             the authorization. The applications can be considered as steps within the longer
             running case or procedure for this authorization process.">application</span> 
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            <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">0..*</td> 
          <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">see 
            <a href="#RegulatedAuthorization.case" title="RegulatedAuthorization.case">case</a>           </td>           <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0
           solid; padding:0px 4px 0px 4px">Applications submitted to obtain a regulated authorization. Steps within the longer
             running case or procedure
            <br/>              <br/>            </td>         </tr>         <tr>           <td class="hierarchy" colspan="5">            <br/>              <a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format">              <img alt="doco" src="help16.png" style="background-color: inherit"/>  Documentation for this format            </a>           </td>         </tr>       </table>     </div>   </text>   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-category">    <valueString value="Specialized.Medication Definition"/>   </extension>   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">    <valueCode value="trial-use"/>   </extension>   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">    <valueInteger value="2"/>   </extension>   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category">    <valueCode value="anonymous"/>   </extension>   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">    <valueCode value="brr"/>   </extension>   <url value="http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization"/>   <version value="5.0.0-draft-final"/>   <name value="RegulatedAuthorization"/>   <status value="draft"/>   <experimental value="false"/>   <date value="2023-03-01T23:03:57+11:00"/>   <publisher value="Health Level Seven International (Biomedical Research and Regulation)"/>   <contact>     <telecom>       <system value="url"/>       <value value="http://hl7.org/fhir"/>     </telecom>   </contact>   <contact>     <telecom>       <system value="url"/>       <value value="http://www.hl7.org/Special/committees/rcrim/index.cfm"/>     </telecom>   </contact>   <description value="Regulatory approval, clearance or licencing related to a regulated product, treatment,
   facility or activity that is cited in a guidance, regulation, rule or legislative
   act. An example is Market Authorization relating to a Medicinal Product."/> 
  <jurisdiction>     <coding>       <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>       <code value="001"/>       <display value="World"/>     </coding>   </jurisdiction>   <fhirVersion value="5.0.0-draft-final"/>   <mapping>     <identity value="idmp"/>     <uri value="https://www.iso.org/obp/ui/#iso:std:iso:11615"/>     <name value="IDMP Mapping"/>   </mapping>   <mapping>     <identity value="w5"/>     <uri value="http://hl7.org/fhir/fivews"/>     <name value="FiveWs Pattern Mapping"/>   </mapping>   <mapping>     <identity value="rim"/>     <uri value="http://hl7.org/v3"/>     <name value="RIM Mapping"/>   </mapping>   <kind value="resource"/>   <abstract value="false"/>   <type value="RegulatedAuthorization"/>   <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>   <derivation value="specialization"/>   <snapshot>     <element id="RegulatedAuthorization">      <path value="RegulatedAuthorization"/>       <short value="Regulatory approval, clearance or licencing related to a regulated product, treatment,
       facility or activity e.g. Market Authorization for a Medicinal Product"/> 
      <definition value="Regulatory approval, clearance or licencing related to a regulated product, treatment,
       facility or activity that is cited in a guidance, regulation, rule or legislative
       act. An example is Market Authorization relating to a Medicinal Product."/> 
      <min value="0"/>       <max value="*"/>       <base>         <path value="RegulatedAuthorization"/>         <min value="0"/>         <max value="*"/>       </base>       <constraint>         <key value="dom-2"/>         <severity value="error"/>         <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>         <expression value="contained.contained.empty()"/>         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>       </constraint>       <constraint>         <key value="dom-3"/>         <severity value="error"/>         <human value="If the resource is contained in another resource, it SHALL be referred to from
         elsewhere in the resource or SHALL refer to the containing resource"/> 
        <expression value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofTy
        pe(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url)))
         or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical)
         = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmat
        ched', id).empty()"/> 
        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>       </constraint>       <constraint>         <key value="dom-4"/>         <severity value="error"/>         <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId
         or a meta.lastUpdated"/> 
        <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>       </constraint>       <constraint>         <key value="dom-5"/>         <severity value="error"/>         <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/>         <expression value="contained.meta.security.empty()"/>         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>       </constraint>       <constraint>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">          <valueBoolean value="true"/>         </extension>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">          <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can
           display the resource to a human safely. Including a human readable representation
           in the resource makes for a much more robust eco-system and cheaper handling of
           resources by intermediary systems. Some ecosystems restrict distribution of resources
           to only those systems that do fully understand the resources, and as a consequence
           implementers may believe that the narrative is superfluous. However experience
           shows that such eco-systems often open up to new participants over time."/> 
        </extension>         <key value="dom-6"/>         <severity value="warning"/>         <human value="A resource should have narrative for robust management"/>         <expression value="text.`div`.exists()"/>         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="false"/>       <mapping>         <identity value="rim"/>         <map value="Entity. Role, or Act"/>       </mapping>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization, Clinical Trial Authorization"/>       </mapping>       <mapping>         <identity value="w5"/>         <map value="administrative.medication"/>       </mapping>     </element>     <element id="RegulatedAuthorization.id">      <path value="RegulatedAuthorization.id"/>       <short value="Logical id of this artifact"/>       <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned,
       this value never changes."/> 
      <comment value="Within the context of the FHIR RESTful interactions, the resource has an id except
       for cases like the create and conditional update. Otherwise, the use of the resouce
       id depends on the given use case."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="Resource.id"/>         <min value="0"/>         <max value="1"/>       </base>       <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler
       magic (j)  -->
      <type>         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">          <valueUrl value="id"/>         </extension>         <code value="http://hl7.org/fhirpath/System.String"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>     </element>     <element id="RegulatedAuthorization.meta">      <path value="RegulatedAuthorization.meta"/>       <short value="Metadata about the resource"/>       <definition value="The metadata about the resource. This is content that is maintained by the infrastructure.
       Changes to the content might not always be associated with version changes to the
       resource."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="Resource.meta"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="Meta"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>     </element>     <element id="RegulatedAuthorization.implicitRules">      <path value="RegulatedAuthorization.implicitRules"/>       <short value="A set of rules under which this content was created"/>       <definition value="A reference to a set of rules that were followed when the resource was constructed,
       and which must be understood when processing the content. Often, this is a reference
       to an implementation guide that defines the special rules along with other profiles
       etc."/> 
      <comment value="Asserting this rule set restricts the content to be only understood by a limited
       set of trading partners. This inherently limits the usefulness of the data in the
       long term. However, the existing health eco-system is highly fractured, and not
       yet ready to define, collect, and exchange data in a generally computable sense.
       Wherever possible, implementers and/or specification writers should avoid using
       this element. Often, when used, the URL is a reference to an implementation guide
       that defines these special rules as part of its narrative along with other profiles,
       value sets, etc."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="Resource.implicitRules"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="uri"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="true"/>       <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional
       knowledge about the resource that modifies its meaning or interpretation"/> 
      <isSummary value="true"/>     </element>     <element id="RegulatedAuthorization.language">      <path value="RegulatedAuthorization.language"/>       <short value="Language of the resource content"/>       <definition value="The base language in which the resource is written."/>       <comment value="Language is provided to support indexing and accessibility (typically, services
       such as text to speech use the language tag). The html language tag in the narrative
       applies  to the narrative. The language tag on the resource may be used to specify
       the language of other presentations generated from the data in the resource. Not
       all the content has to be in the base language. The Resource.language should not
       be assumed to apply to the narrative automatically. If a language is specified,
       it should it also be specified on the div element in the html (see rules in HTML5
       for information about the relationship between xml:lang and the html lang attribute)."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="Resource.language"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="code"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="false"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="Language"/>         </extension>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">          <valueBoolean value="true"/>         </extension>         <strength value="required"/>         <description value="IETF language tag for a human language"/>         <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0-draft-final"/>         <additional>           <purpose value="starter"/>           <valueSet value="http://hl7.org/fhir/ValueSet/languages"/>         </additional>       </binding>     </element>     <element id="RegulatedAuthorization.text">      <path value="RegulatedAuthorization.text"/>       <short value="Text summary of the resource, for human interpretation"/>       <definition value="A human-readable narrative that contains a summary of the resource and can be used
       to represent the content of the resource to a human. The narrative need not encode
       all the structured data, but is required to contain sufficient detail to make it
       &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions
       may define what content should be represented in the narrative to ensure clinical
       safety."/> 
      <comment value="Contained resources do not have a narrative. Resources that are not contained SHOULD
       have a narrative. In some cases, a resource may only have text with little or no
       additional discrete data (as long as all minOccurs=1 elements are satisfied). 
       This may be necessary for data from legacy systems where information is captured
       as a &quot;text blob&quot; or where text is additionally entered raw or narrated
       and encoded information is added later."/> 
      <alias value="narrative"/>       <alias value="html"/>       <alias value="xhtml"/>       <alias value="display"/>       <min value="0"/>       <max value="1"/>       <base>         <path value="DomainResource.text"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="Narrative"/>       </type>       <condition value="dom-6"/>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="false"/>       <mapping>         <identity value="rim"/>         <map value="Act.text?"/>       </mapping>     </element>     <element id="RegulatedAuthorization.contained">      <path value="RegulatedAuthorization.contained"/>       <short value="Contained, inline Resources"/>       <definition value="These resources do not have an independent existence apart from the resource that
       contains them - they cannot be identified independently, nor can they have their
       own independent transaction scope. This is allowed to be a Parameters resource
       if and only if it is referenced by a resource that provides context/meaning."/> 
      <comment value="This should never be done when the content can be identified properly, as once
       identification is lost, it is extremely difficult (and context dependent) to restore
       it again. Contained resources may have profiles and tags in their meta elements,
       but SHALL NOT have security labels."/> 
      <alias value="inline resources"/>       <alias value="anonymous resources"/>       <alias value="contained resources"/>       <min value="0"/>       <max value="*"/>       <base>         <path value="DomainResource.contained"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="Resource"/>       </type>       <condition value="dom-2"/>       <condition value="dom-4"/>       <condition value="dom-3"/>       <condition value="dom-5"/>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="false"/>       <mapping>         <identity value="rim"/>         <map value="N/A"/>       </mapping>     </element>     <element id="RegulatedAuthorization.extension">      <path value="RegulatedAuthorization.extension"/>       <short value="Additional content defined by implementations"/>       <definition value="May be used to represent additional information that is not part of the basic definition
       of the resource. To make the use of extensions safe and managable, there is a strict
       set of governance applied to the definition and use of extensions. Though any implementer
       can define an extension, there is a set of requirements that SHALL be met as part
       of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,
       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <alias value="extensions"/>       <alias value="user content"/>       <min value="0"/>       <max value="*"/>       <base>         <path value="DomainResource.extension"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="Extension"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <constraint>         <key value="ext-1"/>         <severity value="error"/>         <human value="Must have either extensions or value[x], not both"/>         <expression value="extension.exists() != value.exists()"/>         <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="false"/>       <mapping>         <identity value="rim"/>         <map value="N/A"/>       </mapping>     </element>     <element id="RegulatedAuthorization.modifierExtension">      <path value="RegulatedAuthorization.modifierExtension"/>       <short value="Extensions that cannot be ignored"/>       <definition value="May be used to represent additional information that is not part of the basic definition
       of the resource and that modifies the understanding of the element that contains
       it and/or the understanding of the containing element's descendants. Usually modifier
       elements provide negation or qualification. To make the use of extensions safe
       and managable, there is a strict set of governance applied to the definition and
       use of extensions. Though any implementer is allowed to define an extension, there
       is a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,
       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be
       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 
      <alias value="extensions"/>       <alias value="user content"/>       <min value="0"/>       <max value="*"/>       <base>         <path value="DomainResource.modifierExtension"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="Extension"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <constraint>         <key value="ext-1"/>         <severity value="error"/>         <human value="Must have either extensions or value[x], not both"/>         <expression value="extension.exists() != value.exists()"/>         <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="true"/>       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
       resource that contains them"/> 
      <isSummary value="true"/>       <mapping>         <identity value="rim"/>         <map value="N/A"/>       </mapping>     </element>     <element id="RegulatedAuthorization.identifier">      <path value="RegulatedAuthorization.identifier"/>       <short value="Business identifier for the authorization, typically assigned by the authorizing
       body"/> 
      <definition value="Business identifier for the authorization, typically assigned by the authorizing
       body."/> 
      <min value="0"/>       <max value="*"/>       <base>         <path value="RegulatedAuthorization.identifier"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="Identifier"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="w5"/>         <map value="FiveWs.class"/>       </mapping>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Marketing Authorization Number"/>       </mapping>     </element>     <element id="RegulatedAuthorization.subject">      <path value="RegulatedAuthorization.subject"/>       <short value="The product type, treatment, facility or activity that is being authorized"/>       <definition value="The product type, treatment, facility or activity that is being authorized."/>       <min value="0"/>       <max value="*"/>       <base>         <path value="RegulatedAuthorization.subject"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="Reference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/NutritionProduct"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Ingredient"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ActivityDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ObservationDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="(the link to Medicinal Product or Packaged Medicinal Product)"/>       </mapping>     </element>     <element id="RegulatedAuthorization.type">      <path value="RegulatedAuthorization.type"/>       <short value="Overall type of this authorization, for example drug marketing approval, orphan
       drug designation"/> 
      <definition value="Overall type of this authorization, for example drug marketing approval, orphan
       drug designation."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.type"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="CodeableConcept"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="RegulatedAuthorizationType"/>         </extension>         <strength value="example"/>         <description value="Overall type of this authorization."/>         <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-type"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.description">      <path value="RegulatedAuthorization.description"/>       <short value="General textual supporting information"/>       <definition value="General textual supporting information."/>       <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.description"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="markdown"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.region">      <path value="RegulatedAuthorization.region"/>       <short value="The territory in which the authorization has been granted"/>       <definition value="The territory (e.g., country, jurisdiction etc.) in which the authorization has
       been granted."/> 
      <min value="0"/>       <max value="*"/>       <base>         <path value="RegulatedAuthorization.region"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="CodeableConcept"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="Jurisdiction"/>         </extension>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">          <valueBoolean value="true"/>         </extension>         <strength value="example"/>         <description value="Jurisdiction codes"/>         <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Country"/>       </mapping>     </element>     <element id="RegulatedAuthorization.status">      <path value="RegulatedAuthorization.status"/>       <short value="The status that is authorised e.g. approved. Intermediate states can be tracked
       with cases and applications"/> 
      <definition value="The status that is authorised e.g. approved. Intermediate states and actions can
       be tracked with cases and applications."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.status"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="CodeableConcept"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="PublicationStatus"/>         </extension>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">          <valueBoolean value="true"/>         </extension>         <strength value="preferred"/>         <description value="The lifecycle status of an artifact."/>         <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Authorization Status"/>       </mapping>     </element>     <element id="RegulatedAuthorization.statusDate">      <path value="RegulatedAuthorization.statusDate"/>       <short value="The date at which the current status was assigned"/>       <definition value="The date at which the current status was assigned."/>       <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.statusDate"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="dateTime"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Authorization Status Date"/>       </mapping>     </element>     <element id="RegulatedAuthorization.validityPeriod">      <path value="RegulatedAuthorization.validityPeriod"/>       <short value="The time period in which the regulatory approval etc. is in effect, e.g. a Marketing
       Authorization includes the date of authorization and/or expiration date"/> 
      <definition value="The time period in which the regulatory approval, clearance or licencing is in
       effect. As an example, a Marketing Authorization includes the date of authorization
       and/or an expiration date."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.validityPeriod"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="Period"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Validity Period Start, Marketing Authorization.Validity
         Period End"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.indication">      <path value="RegulatedAuthorization.indication"/>       <short value="Condition for which the use of the regulated product applies"/>       <definition value="Condition for which the use of the regulated product applies."/>       <min value="0"/>       <max value="*"/>       <base>         <path value="RegulatedAuthorization.indication"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="CodeableReference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.intendedUse">      <path value="RegulatedAuthorization.intendedUse"/>       <short value="The intended use of the product, e.g. prevention, treatment"/>       <definition value="The intended use of the product, e.g. prevention, treatment, diagnosis."/>       <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.intendedUse"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="CodeableConcept"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="ProductIntendedUse"/>         </extension>         <strength value="preferred"/>         <description value="The overall intended use of a product."/>         <valueSet value="http://hl7.org/fhir/ValueSet/product-intended-use"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.basis">      <path value="RegulatedAuthorization.basis"/>       <short value="The legal/regulatory framework or reasons under which this authorization is granted"/>       <definition value="The legal or regulatory framework against which this authorization is granted,
       or other reasons for it."/> 
      <min value="0"/>       <max value="*"/>       <base>         <path value="RegulatedAuthorization.basis"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="CodeableConcept"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="RegulatedAuthorizationBasis"/>         </extension>         <strength value="example"/>         <description value="A legal or regulatory framework against which an authorization is granted, or other
         reasons for it."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-basis"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Status Reasons.Legal Grounds"/>       </mapping>     </element>     <element id="RegulatedAuthorization.holder">      <path value="RegulatedAuthorization.holder"/>       <short value="The organization that has been granted this authorization, by the regulator"/>       <definition value="The organization that has been granted this authorization, by some authoritative
       body (the 'regulator')."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.holder"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="Reference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Marketing Authorization Holder (Organisation)"/>       </mapping>     </element>     <element id="RegulatedAuthorization.regulator">      <path value="RegulatedAuthorization.regulator"/>       <short value="The regulatory authority or authorizing body granting the authorization"/>       <definition value="The regulatory authority or authorizing body granting the authorization. For example,
       European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada
       (HC), etc."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.regulator"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="Reference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Medicines Regulatory Agency (Organisation)"/>       </mapping>     </element>     <element id="RegulatedAuthorization.attachedDocument">      <path value="RegulatedAuthorization.attachedDocument"/>       <short value="Additional information or supporting documentation about the authorization"/>       <definition value="Additional information or supporting documentation about the authorization."/>       <min value="0"/>       <max value="*"/>       <base>         <path value="RegulatedAuthorization.attachedDocument"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="Reference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.case">      <path value="RegulatedAuthorization.case"/>       <short value="The case or regulatory procedure for granting or amending a regulated authorization.
       Note: This area is subject to ongoing review and the workgroup is seeking implementer
       feedback on its use (see link at bottom of page)"/> 
      <definition value="The case or regulatory procedure for granting or amending a regulated authorization.
       An authorization is granted in response to submissions/applications by those seeking
       authorization. A case is the administrative process that deals with the application(s)
       that relate to this and assesses them. Note: This area is subject to ongoing review
       and the workgroup is seeking implementer feedback on its use (see link at bottom
       of page)."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.case"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="BackboneElement"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization
         Procedure.Marketing Authorization Application"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.case.id">      <path value="RegulatedAuthorization.case.id"/>       <representation value="xmlAttr"/>       <short value="Unique id for inter-element referencing"/>       <definition value="Unique id for the element within a resource (for internal references). This may
       be any string value that does not contain spaces."/> 
      <min value="0"/>       <max value="1"/>       <base>         <path value="Element.id"/>         <min value="0"/>         <max value="1"/>       </base>       <!--  Note: special primitive values have a FHIRPath system type. e.g. this is compiler
       magic (j)  -->
      <type>         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">          <valueUrl value="string"/>         </extension>         <code value="http://hl7.org/fhirpath/System.String"/>       </type>       <condition value="ele-1"/>       <isModifier value="false"/>       <isSummary value="false"/>       <mapping>         <identity value="rim"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.case.extension">      <path value="RegulatedAuthorization.case.extension"/>       <short value="Additional content defined by implementations"/>       <definition value="May be used to represent additional information that is not part of the basic definition
       of the element. To make the use of extensions safe and managable, there is a strict
       set of governance applied to the definition and use of extensions. Though any implementer
       can define an extension, there is a set of requirements that SHALL be met as part
       of the definition of the extension."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,
       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <alias value="extensions"/>       <alias value="user content"/>       <min value="0"/>       <max value="*"/>       <base>         <path value="Element.extension"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="Extension"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <constraint>         <key value="ext-1"/>         <severity value="error"/>         <human value="Must have either extensions or value[x], not both"/>         <expression value="extension.exists() != value.exists()"/>         <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>       </constraint>       <isModifier value="false"/>       <isSummary value="false"/>       <mapping>         <identity value="rim"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.case.modifierExtension">      <path value="RegulatedAuthorization.case.modifierExtension"/>       <short value="Extensions that cannot be ignored even if unrecognized"/>       <definition value="May be used to represent additional information that is not part of the basic definition
       of the element and that modifies the understanding of the element in which it is
       contained and/or the understanding of the containing element's descendants. Usually
       modifier elements provide negation or qualification. To make the use of extensions
       safe and managable, there is a strict set of governance applied to the definition
       and use of extensions. Though any implementer can define an extension, there is
       a set of requirements that SHALL be met as part of the definition of the extension.
       Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or
       DomainResource (including cannot change the meaning of modifierExtension itself)."/> 
      <comment value="There can be no stigma associated with the use of extensions by any application,
       project, or standard - regardless of the institution or jurisdiction that uses
       or defines the extensions.  The use of extensions is what allows the FHIR specification
       to retain a core level of simplicity for everyone."/> 
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be
       clearly distinguished from the vast majority of extensions which can be safely
       ignored.  This promotes interoperability by eliminating the need for implementers
       to prohibit the presence of extensions. For further information, see the [definition
       of modifier extensions](extensibility.html#modifierExtension)."/> 
      <alias value="extensions"/>       <alias value="user content"/>       <alias value="modifiers"/>       <min value="0"/>       <max value="*"/>       <base>         <path value="BackboneElement.modifierExtension"/>         <min value="0"/>         <max value="*"/>       </base>       <type>         <code value="Extension"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <constraint>         <key value="ext-1"/>         <severity value="error"/>         <human value="Must have either extensions or value[x], not both"/>         <expression value="extension.exists() != value.exists()"/>         <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>       </constraint>       <isModifier value="true"/>       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the
       element that contains them"/> 
      <isSummary value="true"/>       <mapping>         <identity value="rim"/>         <map value="N/A"/>       </mapping>     </element>     <element id="RegulatedAuthorization.case.identifier">      <path value="RegulatedAuthorization.case.identifier"/>       <short value="Identifier by which this case can be referenced"/>       <definition value="Identifier by which this case can be referenced."/>       <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.case.identifier"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="Identifier"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization
         Application.Application Identifier / Number"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.case.type">      <path value="RegulatedAuthorization.case.type"/>       <short value="The defining type of case"/>       <definition value="The defining type of case."/>       <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.case.type"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="CodeableConcept"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="RegulatedAuthorizationCaseType"/>         </extension>         <strength value="example"/>         <description value="The type of a case involved in an application."/>         <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Applica
        tion Type"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.case.status">      <path value="RegulatedAuthorization.case.status"/>       <short value="The status associated with the case"/>       <definition value="The status associated with the case."/>       <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.case.status"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="CodeableConcept"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="PublicationStatus"/>         </extension>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">          <valueBoolean value="true"/>         </extension>         <strength value="preferred"/>         <description value="The lifecycle status of an artifact."/>         <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.case.date[x]">      <path value="RegulatedAuthorization.case.date[x]"/>       <short value="Relevant date for this case"/>       <definition value="Relevant date for this case."/>       <min value="0"/>       <max value="1"/>       <base>         <path value="RegulatedAuthorization.case.date[x]"/>         <min value="0"/>         <max value="1"/>       </base>       <type>         <code value="Period"/>       </type>       <type>         <code value="dateTime"/>       </type>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization
         Procedure.Procedure Date End, Marketing Authorization Application.Application Date"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.case.application">      <path value="RegulatedAuthorization.case.application"/>       <short value="Applications submitted to obtain a regulated authorization. Steps within the longer
       running case or procedure"/> 
      <definition value="A regulatory submission from an organization to a regulator, as part of an assessing
       case. Multiple applications may occur over time, with more or different information
       to support or modify the submission or the authorization. The applications can
       be considered as steps within the longer running case or procedure for this authorization
       process."/> 
      <min value="0"/>       <max value="*"/>       <base>         <path value="RegulatedAuthorization.case.application"/>         <min value="0"/>         <max value="*"/>       </base>       <contentReference value="#RegulatedAuthorization.case"/>       <constraint>         <key value="ele-1"/>         <severity value="error"/>         <human value="All FHIR elements must have a @value or children"/>         <expression value="hasValue() or (children().count() &gt; id.count())"/>         <source value="http://hl7.org/fhir/StructureDefinition/Element"/>       </constraint>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Marketing Authorization Application"/>       </mapping>     </element>   </snapshot>   <differential>     <element id="RegulatedAuthorization">      <path value="RegulatedAuthorization"/>       <short value="Regulatory approval, clearance or licencing related to a regulated product, treatment,
       facility or activity e.g. Market Authorization for a Medicinal Product"/> 
      <definition value="Regulatory approval, clearance or licencing related to a regulated product, treatment,
       facility or activity that is cited in a guidance, regulation, rule or legislative
       act. An example is Market Authorization relating to a Medicinal Product."/> 
      <min value="0"/>       <max value="*"/>       <mustSupport value="false"/>       <isModifier value="false"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization, Clinical Trial Authorization"/>       </mapping>       <mapping>         <identity value="w5"/>         <map value="administrative.medication"/>       </mapping>     </element>     <element id="RegulatedAuthorization.identifier">      <path value="RegulatedAuthorization.identifier"/>       <short value="Business identifier for the authorization, typically assigned by the authorizing
       body"/> 
      <definition value="Business identifier for the authorization, typically assigned by the authorizing
       body."/> 
      <min value="0"/>       <max value="*"/>       <type>         <code value="Identifier"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="w5"/>         <map value="FiveWs.class"/>       </mapping>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Marketing Authorization Number"/>       </mapping>     </element>     <element id="RegulatedAuthorization.subject">      <path value="RegulatedAuthorization.subject"/>       <short value="The product type, treatment, facility or activity that is being authorized"/>       <definition value="The product type, treatment, facility or activity that is being authorized."/>       <min value="0"/>       <max value="*"/>       <type>         <code value="Reference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/NutritionProduct"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Ingredient"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ActivityDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ObservationDefinition"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="(the link to Medicinal Product or Packaged Medicinal Product)"/>       </mapping>     </element>     <element id="RegulatedAuthorization.type">      <path value="RegulatedAuthorization.type"/>       <short value="Overall type of this authorization, for example drug marketing approval, orphan
       drug designation"/> 
      <definition value="Overall type of this authorization, for example drug marketing approval, orphan
       drug designation."/> 
      <min value="0"/>       <max value="1"/>       <type>         <code value="CodeableConcept"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="RegulatedAuthorizationType"/>         </extension>         <strength value="example"/>         <description value="Overall type of this authorization."/>         <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-type"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.description">      <path value="RegulatedAuthorization.description"/>       <short value="General textual supporting information"/>       <definition value="General textual supporting information."/>       <min value="0"/>       <max value="1"/>       <type>         <code value="markdown"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.region">      <path value="RegulatedAuthorization.region"/>       <short value="The territory in which the authorization has been granted"/>       <definition value="The territory (e.g., country, jurisdiction etc.) in which the authorization has
       been granted."/> 
      <min value="0"/>       <max value="*"/>       <type>         <code value="CodeableConcept"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="Jurisdiction"/>         </extension>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">          <valueBoolean value="true"/>         </extension>         <strength value="example"/>         <description value="Jurisdiction codes"/>         <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Country"/>       </mapping>     </element>     <element id="RegulatedAuthorization.status">      <path value="RegulatedAuthorization.status"/>       <short value="The status that is authorised e.g. approved. Intermediate states can be tracked
       with cases and applications"/> 
      <definition value="The status that is authorised e.g. approved. Intermediate states and actions can
       be tracked with cases and applications."/> 
      <min value="0"/>       <max value="1"/>       <type>         <code value="CodeableConcept"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="PublicationStatus"/>         </extension>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">          <valueBoolean value="true"/>         </extension>         <strength value="preferred"/>         <description value="The lifecycle status of an artifact."/>         <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Authorization Status"/>       </mapping>     </element>     <element id="RegulatedAuthorization.statusDate">      <path value="RegulatedAuthorization.statusDate"/>       <short value="The date at which the current status was assigned"/>       <definition value="The date at which the current status was assigned."/>       <min value="0"/>       <max value="1"/>       <type>         <code value="dateTime"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Authorization Status Date"/>       </mapping>     </element>     <element id="RegulatedAuthorization.validityPeriod">      <path value="RegulatedAuthorization.validityPeriod"/>       <short value="The time period in which the regulatory approval etc. is in effect, e.g. a Marketing
       Authorization includes the date of authorization and/or expiration date"/> 
      <definition value="The time period in which the regulatory approval, clearance or licencing is in
       effect. As an example, a Marketing Authorization includes the date of authorization
       and/or an expiration date."/> 
      <min value="0"/>       <max value="1"/>       <type>         <code value="Period"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Validity Period Start, Marketing Authorization.Validity
         Period End"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.indication">      <path value="RegulatedAuthorization.indication"/>       <short value="Condition for which the use of the regulated product applies"/>       <definition value="Condition for which the use of the regulated product applies."/>       <min value="0"/>       <max value="*"/>       <type>         <code value="CodeableReference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.intendedUse">      <path value="RegulatedAuthorization.intendedUse"/>       <short value="The intended use of the product, e.g. prevention, treatment"/>       <definition value="The intended use of the product, e.g. prevention, treatment, diagnosis."/>       <min value="0"/>       <max value="1"/>       <type>         <code value="CodeableConcept"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="ProductIntendedUse"/>         </extension>         <strength value="preferred"/>         <description value="The overall intended use of a product."/>         <valueSet value="http://hl7.org/fhir/ValueSet/product-intended-use"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.basis">      <path value="RegulatedAuthorization.basis"/>       <short value="The legal/regulatory framework or reasons under which this authorization is granted"/>       <definition value="The legal or regulatory framework against which this authorization is granted,
       or other reasons for it."/> 
      <min value="0"/>       <max value="*"/>       <type>         <code value="CodeableConcept"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="RegulatedAuthorizationBasis"/>         </extension>         <strength value="example"/>         <description value="A legal or regulatory framework against which an authorization is granted, or other
         reasons for it."/> 
        <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-basis"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Status Reasons.Legal Grounds"/>       </mapping>     </element>     <element id="RegulatedAuthorization.holder">      <path value="RegulatedAuthorization.holder"/>       <short value="The organization that has been granted this authorization, by the regulator"/>       <definition value="The organization that has been granted this authorization, by some authoritative
       body (the 'regulator')."/> 
      <min value="0"/>       <max value="1"/>       <type>         <code value="Reference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Marketing Authorization Holder (Organisation)"/>       </mapping>     </element>     <element id="RegulatedAuthorization.regulator">      <path value="RegulatedAuthorization.regulator"/>       <short value="The regulatory authority or authorizing body granting the authorization"/>       <definition value="The regulatory authority or authorizing body granting the authorization. For example,
       European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada
       (HC), etc."/> 
      <min value="0"/>       <max value="1"/>       <type>         <code value="Reference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Medicines Regulatory Agency (Organisation)"/>       </mapping>     </element>     <element id="RegulatedAuthorization.attachedDocument">      <path value="RegulatedAuthorization.attachedDocument"/>       <short value="Additional information or supporting documentation about the authorization"/>       <definition value="Additional information or supporting documentation about the authorization."/>       <min value="0"/>       <max value="*"/>       <type>         <code value="Reference"/>         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.case">      <path value="RegulatedAuthorization.case"/>       <short value="The case or regulatory procedure for granting or amending a regulated authorization.
       Note: This area is subject to ongoing review and the workgroup is seeking implementer
       feedback on its use (see link at bottom of page)"/> 
      <definition value="The case or regulatory procedure for granting or amending a regulated authorization.
       An authorization is granted in response to submissions/applications by those seeking
       authorization. A case is the administrative process that deals with the application(s)
       that relate to this and assesses them. Note: This area is subject to ongoing review
       and the workgroup is seeking implementer feedback on its use (see link at bottom
       of page)."/> 
      <min value="0"/>       <max value="1"/>       <type>         <code value="BackboneElement"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization
         Procedure.Marketing Authorization Application"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.case.identifier">      <path value="RegulatedAuthorization.case.identifier"/>       <short value="Identifier by which this case can be referenced"/>       <definition value="Identifier by which this case can be referenced."/>       <min value="0"/>       <max value="1"/>       <type>         <code value="Identifier"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization
         Application.Application Identifier / Number"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.case.type">      <path value="RegulatedAuthorization.case.type"/>       <short value="The defining type of case"/>       <definition value="The defining type of case."/>       <min value="0"/>       <max value="1"/>       <type>         <code value="CodeableConcept"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="RegulatedAuthorizationCaseType"/>         </extension>         <strength value="example"/>         <description value="The type of a case involved in an application."/>         <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Applica
        tion Type"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.case.status">      <path value="RegulatedAuthorization.case.status"/>       <short value="The status associated with the case"/>       <definition value="The status associated with the case."/>       <min value="0"/>       <max value="1"/>       <type>         <code value="CodeableConcept"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <binding>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">          <valueString value="PublicationStatus"/>         </extension>         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">          <valueBoolean value="true"/>         </extension>         <strength value="preferred"/>         <description value="The lifecycle status of an artifact."/>         <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>       </binding>       <mapping>         <identity value="idmp"/>         <map value="n/a"/>       </mapping>     </element>     <element id="RegulatedAuthorization.case.date[x]">      <path value="RegulatedAuthorization.case.date[x]"/>       <short value="Relevant date for this case"/>       <definition value="Relevant date for this case."/>       <min value="0"/>       <max value="1"/>       <type>         <code value="Period"/>       </type>       <type>         <code value="dateTime"/>       </type>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization
         Procedure.Procedure Date End, Marketing Authorization Application.Application Date"/> 
      </mapping>     </element>     <element id="RegulatedAuthorization.case.application">      <path value="RegulatedAuthorization.case.application"/>       <short value="Applications submitted to obtain a regulated authorization. Steps within the longer
       running case or procedure"/> 
      <definition value="A regulatory submission from an organization to a regulator, as part of an assessing
       case. Multiple applications may occur over time, with more or different information
       to support or modify the submission or the authorization. The applications can
       be considered as steps within the longer running case or procedure for this authorization
       process."/> 
      <min value="0"/>       <max value="*"/>       <contentReference value="#RegulatedAuthorization.case"/>       <mustSupport value="false"/>       <isModifier value="false"/>       <isSummary value="true"/>       <mapping>         <identity value="idmp"/>         <map value="Marketing Authorization.Marketing Authorization Application"/>       </mapping>     </element>   </differential> 


</

StructureDefinition

>

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.