MedicinalProduct.xml
   1 <?xml version="1.0" encoding="utf-8"?>
   2 <StructureDefinition xmlns="http://hl7.org/fhir">
   3   <id value="MedicinalProduct" />
   4   <meta>
   5     <lastUpdated value="2019-10-31T23:29:23.356+01:00" />
   6   </meta>
   7   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-category">
   8     <valueString value="Specialized.Medication Definition" />
   9   </extension>
  10   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
  11     <valueCode value="trial-use" />
  12   </extension>
  13   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
  14     <valueInteger value="0" />
  15   </extension>
  16   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category">
  17     <valueCode value="anonymous" />
  18   </extension>
  19   <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
  20     <valueCode value="brr" />
  21   </extension>
  22   <url value="http://hl7.org/fhir/StructureDefinition/MedicinalProduct" />
  23   <version value="4.0.1" />
  24   <name value="MedicinalProduct" />
  25   <status value="draft" />
  26   <date value="2019-10-31T23:29:23.0000000+01:00" />
  27   <publisher value="Health Level Seven International (Biomedical Research and Regulation)" />
  28   <contact>
  29     <telecom>
  30       <system value="url" />
  31       <value value="http://hl7.org/fhir" />
  32     </telecom>
  33   </contact>
  34   <contact>
  35     <telecom>
  36       <system value="url" />
  37       <value value="http://www.hl7.org/Special/committees/rcrim/index.cfm" />
  38     </telecom>
  39   </contact>
  40   <description value="Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)." />
  41   <fhirVersion value="4.0.1" />
  42   <mapping>
  43     <identity value="rim" />
  44     <uri value="http://hl7.org/v3" />
  45     <name value="RIM Mapping" />
  46   </mapping>
  47   <kind value="resource" />
  48   <abstract value="false" />
  49   <type value="MedicinalProduct" />
  50   <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
  51   <derivation value="specialization" />
  52   <snapshot>
  53     <element id="MedicinalProduct">
  54       <path value="MedicinalProduct" />
  55       <short value="Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)" />
  56       <definition value="Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)." />
  57       <min value="0" />
  58       <max value="*" />
  59       <base>
  60         <path value="MedicinalProduct" />
  61         <min value="0" />
  62         <max value="*" />
  63       </base>
  64       <constraint>
  65         <key value="dom-2" />
  66         <severity value="error" />
  67         <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" />
  68         <expression value="contained.contained.empty()" />
  69         <xpath value="not(parent::f:contained and f:contained)" />
  70         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
  71       </constraint>
  72       <constraint>
  73         <key value="dom-3" />
  74         <severity value="error" />
  75         <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" />
  76         <expression value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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(canonical) = '#').exists()).not()).trace('unmatched', id).empty()" />
  77         <xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))" />
  78         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
  79       </constraint>
  80       <constraint>
  81         <key value="dom-4" />
  82         <severity value="error" />
  83         <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" />
  84         <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()" />
  85         <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" />
  86         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
  87       </constraint>
  88       <constraint>
  89         <key value="dom-5" />
  90         <severity value="error" />
  91         <human value="If a resource is contained in another resource, it SHALL NOT have a security label" />
  92         <expression value="contained.meta.security.empty()" />
  93         <xpath value="not(exists(f:contained/*/f:meta/f:security))" />
  94         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
  95       </constraint>
  96       <constraint>
  97         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
  98           <valueBoolean value="true" />
  99         </extension>
 100         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
 101           <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." />
 102         </extension>
 103         <key value="dom-6" />
 104         <severity value="warning" />
 105         <human value="A resource should have narrative for robust management" />
 106         <expression value="text.`div`.exists()" />
 107         <xpath value="exists(f:text/h:div)" />
 108         <source value="http://hl7.org/fhir/StructureDefinition/DomainResource" />
 109       </constraint>
 110       <isModifier value="false" />
 111       <isSummary value="false" />
 112       <mapping>
 113         <identity value="rim" />
 114         <map value="Entity. Role, or Act" />
 115       </mapping>
 116     </element>
 117     <element id="MedicinalProduct.id">
 118       <path value="MedicinalProduct.id" />
 119       <short value="Logical id of this artifact" />
 120       <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes." />
 121       <comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation." />
 122       <min value="0" />
 123       <max value="1" />
 124       <base>
 125         <path value="Resource.id" />
 126         <min value="0" />
 127         <max value="1" />
 128       </base>
 129       <type>
 130         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
 131           <valueUrl value="string" />
 132         </extension>
 133         <code value="http://hl7.org/fhirpath/System.String" />
 134       </type>
 135       <isModifier value="false" />
 136       <isSummary value="true" />
 137     </element>
 138     <element id="MedicinalProduct.meta">
 139       <path value="MedicinalProduct.meta" />
 140       <short value="Metadata about the resource" />
 141       <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." />
 142       <min value="0" />
 143       <max value="1" />
 144       <base>
 145         <path value="Resource.meta" />
 146         <min value="0" />
 147         <max value="1" />
 148       </base>
 149       <type>
 150         <code value="Meta" />
 151       </type>
 152       <constraint>
 153         <key value="ele-1" />
 154         <severity value="error" />
 155         <human value="All FHIR elements must have a @value or children" />
 156         <expression value="hasValue() or (children().count() > id.count())" />
 157         <xpath value="@value|f:*|h:div" />
 158         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 159       </constraint>
 160       <isModifier value="false" />
 161       <isSummary value="true" />
 162     </element>
 163     <element id="MedicinalProduct.implicitRules">
 164       <path value="MedicinalProduct.implicitRules" />
 165       <short value="A set of rules under which this content was created" />
 166       <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." />
 167       <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 it's narrative along with other profiles, value sets, etc." />
 168       <min value="0" />
 169       <max value="1" />
 170       <base>
 171         <path value="Resource.implicitRules" />
 172         <min value="0" />
 173         <max value="1" />
 174       </base>
 175       <type>
 176         <code value="uri" />
 177       </type>
 178       <constraint>
 179         <key value="ele-1" />
 180         <severity value="error" />
 181         <human value="All FHIR elements must have a @value or children" />
 182         <expression value="hasValue() or (children().count() > id.count())" />
 183         <xpath value="@value|f:*|h:div" />
 184         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 185       </constraint>
 186       <isModifier value="true" />
 187       <isModifierReason value="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" />
 188       <isSummary value="true" />
 189     </element>
 190     <element id="MedicinalProduct.language">
 191       <path value="MedicinalProduct.language" />
 192       <short value="Language of the resource content" />
 193       <definition value="The base language in which the resource is written." />
 194       <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)." />
 195       <min value="0" />
 196       <max value="1" />
 197       <base>
 198         <path value="Resource.language" />
 199         <min value="0" />
 200         <max value="1" />
 201       </base>
 202       <type>
 203         <code value="code" />
 204       </type>
 205       <constraint>
 206         <key value="ele-1" />
 207         <severity value="error" />
 208         <human value="All FHIR elements must have a @value or children" />
 209         <expression value="hasValue() or (children().count() > id.count())" />
 210         <xpath value="@value|f:*|h:div" />
 211         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 212       </constraint>
 213       <isModifier value="false" />
 214       <isSummary value="false" />
 215       <binding>
 216         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
 217           <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages" />
 218         </extension>
 219         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
 220           <valueString value="Language" />
 221         </extension>
 222         <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
 223           <valueBoolean value="true" />
 224         </extension>
 225         <strength value="preferred" />
 226         <description value="A human language." />
 227         <valueSet value="http://hl7.org/fhir/ValueSet/languages" />
 228       </binding>
 229     </element>
 230     <element id="MedicinalProduct.text">
 231       <path value="MedicinalProduct.text" />
 232       <short value="Text summary of the resource, for human interpretation" />
 233       <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 "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety." />
 234       <comment value="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 "text blob" or where text is additionally entered raw or narrated and encoded information is added later." />
 235       <alias value="narrative" />
 236       <alias value="html" />
 237       <alias value="xhtml" />
 238       <alias value="display" />
 239       <min value="0" />
 240       <max value="1" />
 241       <base>
 242         <path value="DomainResource.text" />
 243         <min value="0" />
 244         <max value="1" />
 245       </base>
 246       <type>
 247         <code value="Narrative" />
 248       </type>
 249       <constraint>
 250         <key value="ele-1" />
 251         <severity value="error" />
 252         <human value="All FHIR elements must have a @value or children" />
 253         <expression value="hasValue() or (children().count() > id.count())" />
 254         <xpath value="@value|f:*|h:div" />
 255         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 256       </constraint>
 257       <isModifier value="false" />
 258       <isSummary value="false" />
 259       <mapping>
 260         <identity value="rim" />
 261         <map value="Act.text?" />
 262       </mapping>
 263     </element>
 264     <element id="MedicinalProduct.contained">
 265       <path value="MedicinalProduct.contained" />
 266       <short value="Contained, inline Resources" />
 267       <definition value="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." />
 268       <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." />
 269       <alias value="inline resources" />
 270       <alias value="anonymous resources" />
 271       <alias value="contained resources" />
 272       <min value="0" />
 273       <max value="*" />
 274       <base>
 275         <path value="DomainResource.contained" />
 276         <min value="0" />
 277         <max value="*" />
 278       </base>
 279       <type>
 280         <code value="Resource" />
 281       </type>
 282       <isModifier value="false" />
 283       <isSummary value="false" />
 284       <mapping>
 285         <identity value="rim" />
 286         <map value="N/A" />
 287       </mapping>
 288     </element>
 289     <element id="MedicinalProduct.extension">
 290       <path value="MedicinalProduct.extension" />
 291       <short value="Additional content defined by implementations" />
 292       <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 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." />
 293       <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." />
 294       <alias value="extensions" />
 295       <alias value="user content" />
 296       <min value="0" />
 297       <max value="*" />
 298       <base>
 299         <path value="DomainResource.extension" />
 300         <min value="0" />
 301         <max value="*" />
 302       </base>
 303       <type>
 304         <code value="Extension" />
 305       </type>
 306       <constraint>
 307         <key value="ele-1" />
 308         <severity value="error" />
 309         <human value="All FHIR elements must have a @value or children" />
 310         <expression value="hasValue() or (children().count() > id.count())" />
 311         <xpath value="@value|f:*|h:div" />
 312         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 313       </constraint>
 314       <constraint>
 315         <key value="ext-1" />
 316         <severity value="error" />
 317         <human value="Must have either extensions or value[x], not both" />
 318         <expression value="extension.exists() != value.exists()" />
 319         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
 320         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 321       </constraint>
 322       <isModifier value="false" />
 323       <isSummary value="false" />
 324       <mapping>
 325         <identity value="rim" />
 326         <map value="N/A" />
 327       </mapping>
 328     </element>
 329     <element id="MedicinalProduct.modifierExtension">
 330       <path value="MedicinalProduct.modifierExtension" />
 331       <short value="Extensions that cannot be ignored" />
 332       <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 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)." />
 333       <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." />
 334       <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)." />
 335       <alias value="extensions" />
 336       <alias value="user content" />
 337       <min value="0" />
 338       <max value="*" />
 339       <base>
 340         <path value="DomainResource.modifierExtension" />
 341         <min value="0" />
 342         <max value="*" />
 343       </base>
 344       <type>
 345         <code value="Extension" />
 346       </type>
 347       <constraint>
 348         <key value="ele-1" />
 349         <severity value="error" />
 350         <human value="All FHIR elements must have a @value or children" />
 351         <expression value="hasValue() or (children().count() > id.count())" />
 352         <xpath value="@value|f:*|h:div" />
 353         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 354       </constraint>
 355       <constraint>
 356         <key value="ext-1" />
 357         <severity value="error" />
 358         <human value="Must have either extensions or value[x], not both" />
 359         <expression value="extension.exists() != value.exists()" />
 360         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
 361         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 362       </constraint>
 363       <isModifier value="true" />
 364       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" />
 365       <isSummary value="false" />
 366       <mapping>
 367         <identity value="rim" />
 368         <map value="N/A" />
 369       </mapping>
 370     </element>
 371     <element id="MedicinalProduct.identifier">
 372       <path value="MedicinalProduct.identifier" />
 373       <short value="Business identifier for this product. Could be an MPID" />
 374       <definition value="Business identifier for this product. Could be an MPID." />
 375       <alias value="MPID" />
 376       <min value="0" />
 377       <max value="*" />
 378       <base>
 379         <path value="MedicinalProduct.identifier" />
 380         <min value="0" />
 381         <max value="*" />
 382       </base>
 383       <type>
 384         <code value="Identifier" />
 385       </type>
 386       <constraint>
 387         <key value="ele-1" />
 388         <severity value="error" />
 389         <human value="All FHIR elements must have a @value or children" />
 390         <expression value="hasValue() or (children().count() > id.count())" />
 391         <xpath value="@value|f:*|h:div" />
 392         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 393       </constraint>
 394       <isModifier value="false" />
 395       <isSummary value="true" />
 396     </element>
 397     <element id="MedicinalProduct.type">
 398       <path value="MedicinalProduct.type" />
 399       <short value="Regulatory type, e.g. Investigational or Authorized" />
 400       <definition value="Regulatory type, e.g. Investigational or Authorized." />
 401       <min value="0" />
 402       <max value="1" />
 403       <base>
 404         <path value="MedicinalProduct.type" />
 405         <min value="0" />
 406         <max value="1" />
 407       </base>
 408       <type>
 409         <code value="CodeableConcept" />
 410       </type>
 411       <constraint>
 412         <key value="ele-1" />
 413         <severity value="error" />
 414         <human value="All FHIR elements must have a @value or children" />
 415         <expression value="hasValue() or (children().count() > id.count())" />
 416         <xpath value="@value|f:*|h:div" />
 417         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 418       </constraint>
 419       <isModifier value="false" />
 420       <isSummary value="true" />
 421     </element>
 422     <element id="MedicinalProduct.domain">
 423       <path value="MedicinalProduct.domain" />
 424       <short value="If this medicine applies to human or veterinary uses" />
 425       <definition value="If this medicine applies to human or veterinary uses." />
 426       <min value="0" />
 427       <max value="1" />
 428       <base>
 429         <path value="MedicinalProduct.domain" />
 430         <min value="0" />
 431         <max value="1" />
 432       </base>
 433       <type>
 434         <code value="Coding" />
 435       </type>
 436       <constraint>
 437         <key value="ele-1" />
 438         <severity value="error" />
 439         <human value="All FHIR elements must have a @value or children" />
 440         <expression value="hasValue() or (children().count() > id.count())" />
 441         <xpath value="@value|f:*|h:div" />
 442         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 443       </constraint>
 444       <isModifier value="false" />
 445       <isSummary value="true" />
 446     </element>
 447     <element id="MedicinalProduct.combinedPharmaceuticalDoseForm">
 448       <path value="MedicinalProduct.combinedPharmaceuticalDoseForm" />
 449       <short value="The dose form for a single part product, or combined form of a multiple part product" />
 450       <definition value="The dose form for a single part product, or combined form of a multiple part product." />
 451       <min value="0" />
 452       <max value="1" />
 453       <base>
 454         <path value="MedicinalProduct.combinedPharmaceuticalDoseForm" />
 455         <min value="0" />
 456         <max value="1" />
 457       </base>
 458       <type>
 459         <code value="CodeableConcept" />
 460       </type>
 461       <constraint>
 462         <key value="ele-1" />
 463         <severity value="error" />
 464         <human value="All FHIR elements must have a @value or children" />
 465         <expression value="hasValue() or (children().count() > id.count())" />
 466         <xpath value="@value|f:*|h:div" />
 467         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 468       </constraint>
 469       <isModifier value="false" />
 470       <isSummary value="true" />
 471     </element>
 472     <element id="MedicinalProduct.legalStatusOfSupply">
 473       <path value="MedicinalProduct.legalStatusOfSupply" />
 474       <short value="The legal status of supply of the medicinal product as classified by the regulator" />
 475       <definition value="The legal status of supply of the medicinal product as classified by the regulator." />
 476       <min value="0" />
 477       <max value="1" />
 478       <base>
 479         <path value="MedicinalProduct.legalStatusOfSupply" />
 480         <min value="0" />
 481         <max value="1" />
 482       </base>
 483       <type>
 484         <code value="CodeableConcept" />
 485       </type>
 486       <constraint>
 487         <key value="ele-1" />
 488         <severity value="error" />
 489         <human value="All FHIR elements must have a @value or children" />
 490         <expression value="hasValue() or (children().count() > id.count())" />
 491         <xpath value="@value|f:*|h:div" />
 492         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 493       </constraint>
 494       <isModifier value="false" />
 495       <isSummary value="true" />
 496     </element>
 497     <element id="MedicinalProduct.additionalMonitoringIndicator">
 498       <path value="MedicinalProduct.additionalMonitoringIndicator" />
 499       <short value="Whether the Medicinal Product is subject to additional monitoring for regulatory reasons" />
 500       <definition value="Whether the Medicinal Product is subject to additional monitoring for regulatory reasons." />
 501       <min value="0" />
 502       <max value="1" />
 503       <base>
 504         <path value="MedicinalProduct.additionalMonitoringIndicator" />
 505         <min value="0" />
 506         <max value="1" />
 507       </base>
 508       <type>
 509         <code value="CodeableConcept" />
 510       </type>
 511       <constraint>
 512         <key value="ele-1" />
 513         <severity value="error" />
 514         <human value="All FHIR elements must have a @value or children" />
 515         <expression value="hasValue() or (children().count() > id.count())" />
 516         <xpath value="@value|f:*|h:div" />
 517         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 518       </constraint>
 519       <isModifier value="false" />
 520       <isSummary value="true" />
 521     </element>
 522     <element id="MedicinalProduct.specialMeasures">
 523       <path value="MedicinalProduct.specialMeasures" />
 524       <short value="Whether the Medicinal Product is subject to special measures for regulatory reasons" />
 525       <definition value="Whether the Medicinal Product is subject to special measures for regulatory reasons." />
 526       <min value="0" />
 527       <max value="*" />
 528       <base>
 529         <path value="MedicinalProduct.specialMeasures" />
 530         <min value="0" />
 531         <max value="*" />
 532       </base>
 533       <type>
 534         <code value="string" />
 535       </type>
 536       <constraint>
 537         <key value="ele-1" />
 538         <severity value="error" />
 539         <human value="All FHIR elements must have a @value or children" />
 540         <expression value="hasValue() or (children().count() > id.count())" />
 541         <xpath value="@value|f:*|h:div" />
 542         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 543       </constraint>
 544       <isModifier value="false" />
 545       <isSummary value="true" />
 546     </element>
 547     <element id="MedicinalProduct.paediatricUseIndicator">
 548       <path value="MedicinalProduct.paediatricUseIndicator" />
 549       <short value="If authorised for use in children" />
 550       <definition value="If authorised for use in children." />
 551       <min value="0" />
 552       <max value="1" />
 553       <base>
 554         <path value="MedicinalProduct.paediatricUseIndicator" />
 555         <min value="0" />
 556         <max value="1" />
 557       </base>
 558       <type>
 559         <code value="CodeableConcept" />
 560       </type>
 561       <constraint>
 562         <key value="ele-1" />
 563         <severity value="error" />
 564         <human value="All FHIR elements must have a @value or children" />
 565         <expression value="hasValue() or (children().count() > id.count())" />
 566         <xpath value="@value|f:*|h:div" />
 567         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 568       </constraint>
 569       <isModifier value="false" />
 570       <isSummary value="true" />
 571     </element>
 572     <element id="MedicinalProduct.productClassification">
 573       <path value="MedicinalProduct.productClassification" />
 574       <short value="Allows the product to be classified by various systems" />
 575       <definition value="Allows the product to be classified by various systems." />
 576       <min value="0" />
 577       <max value="*" />
 578       <base>
 579         <path value="MedicinalProduct.productClassification" />
 580         <min value="0" />
 581         <max value="*" />
 582       </base>
 583       <type>
 584         <code value="CodeableConcept" />
 585       </type>
 586       <constraint>
 587         <key value="ele-1" />
 588         <severity value="error" />
 589         <human value="All FHIR elements must have a @value or children" />
 590         <expression value="hasValue() or (children().count() > id.count())" />
 591         <xpath value="@value|f:*|h:div" />
 592         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 593       </constraint>
 594       <isModifier value="false" />
 595       <isSummary value="true" />
 596     </element>
 597     <element id="MedicinalProduct.marketingStatus">
 598       <path value="MedicinalProduct.marketingStatus" />
 599       <short value="Marketing status of the medicinal product, in contrast to marketing authorizaton" />
 600       <definition value="Marketing status of the medicinal product, in contrast to marketing authorizaton." />
 601       <min value="0" />
 602       <max value="*" />
 603       <base>
 604         <path value="MedicinalProduct.marketingStatus" />
 605         <min value="0" />
 606         <max value="*" />
 607       </base>
 608       <type>
 609         <code value="MarketingStatus" />
 610       </type>
 611       <constraint>
 612         <key value="ele-1" />
 613         <severity value="error" />
 614         <human value="All FHIR elements must have a @value or children" />
 615         <expression value="hasValue() or (children().count() > id.count())" />
 616         <xpath value="@value|f:*|h:div" />
 617         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 618       </constraint>
 619       <isModifier value="false" />
 620       <isSummary value="true" />
 621     </element>
 622     <element id="MedicinalProduct.pharmaceuticalProduct">
 623       <path value="MedicinalProduct.pharmaceuticalProduct" />
 624       <short value="Pharmaceutical aspects of product" />
 625       <definition value="Pharmaceutical aspects of product." />
 626       <min value="0" />
 627       <max value="*" />
 628       <base>
 629         <path value="MedicinalProduct.pharmaceuticalProduct" />
 630         <min value="0" />
 631         <max value="*" />
 632       </base>
 633       <type>
 634         <code value="Reference" />
 635         <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductPharmaceutical" />
 636       </type>
 637       <constraint>
 638         <key value="ele-1" />
 639         <severity value="error" />
 640         <human value="All FHIR elements must have a @value or children" />
 641         <expression value="hasValue() or (children().count() > id.count())" />
 642         <xpath value="@value|f:*|h:div" />
 643         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 644       </constraint>
 645       <isModifier value="false" />
 646       <isSummary value="true" />
 647     </element>
 648     <element id="MedicinalProduct.packagedMedicinalProduct">
 649       <path value="MedicinalProduct.packagedMedicinalProduct" />
 650       <short value="Package representation for the product" />
 651       <definition value="Package representation for the product." />
 652       <min value="0" />
 653       <max value="*" />
 654       <base>
 655         <path value="MedicinalProduct.packagedMedicinalProduct" />
 656         <min value="0" />
 657         <max value="*" />
 658       </base>
 659       <type>
 660         <code value="Reference" />
 661         <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged" />
 662       </type>
 663       <constraint>
 664         <key value="ele-1" />
 665         <severity value="error" />
 666         <human value="All FHIR elements must have a @value or children" />
 667         <expression value="hasValue() or (children().count() > id.count())" />
 668         <xpath value="@value|f:*|h:div" />
 669         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 670       </constraint>
 671       <isModifier value="false" />
 672       <isSummary value="true" />
 673     </element>
 674     <element id="MedicinalProduct.attachedDocument">
 675       <path value="MedicinalProduct.attachedDocument" />
 676       <short value="Supporting documentation, typically for regulatory submission" />
 677       <definition value="Supporting documentation, typically for regulatory submission." />
 678       <min value="0" />
 679       <max value="*" />
 680       <base>
 681         <path value="MedicinalProduct.attachedDocument" />
 682         <min value="0" />
 683         <max value="*" />
 684       </base>
 685       <type>
 686         <code value="Reference" />
 687         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference" />
 688       </type>
 689       <constraint>
 690         <key value="ele-1" />
 691         <severity value="error" />
 692         <human value="All FHIR elements must have a @value or children" />
 693         <expression value="hasValue() or (children().count() > id.count())" />
 694         <xpath value="@value|f:*|h:div" />
 695         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 696       </constraint>
 697       <isModifier value="false" />
 698       <isSummary value="true" />
 699     </element>
 700     <element id="MedicinalProduct.masterFile">
 701       <path value="MedicinalProduct.masterFile" />
 702       <short value="A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)" />
 703       <definition value="A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)." />
 704       <min value="0" />
 705       <max value="*" />
 706       <base>
 707         <path value="MedicinalProduct.masterFile" />
 708         <min value="0" />
 709         <max value="*" />
 710       </base>
 711       <type>
 712         <code value="Reference" />
 713         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference" />
 714       </type>
 715       <constraint>
 716         <key value="ele-1" />
 717         <severity value="error" />
 718         <human value="All FHIR elements must have a @value or children" />
 719         <expression value="hasValue() or (children().count() > id.count())" />
 720         <xpath value="@value|f:*|h:div" />
 721         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 722       </constraint>
 723       <isModifier value="false" />
 724       <isSummary value="true" />
 725     </element>
 726     <element id="MedicinalProduct.contact">
 727       <path value="MedicinalProduct.contact" />
 728       <short value="A product specific contact, person (in a role), or an organization" />
 729       <definition value="A product specific contact, person (in a role), or an organization." />
 730       <min value="0" />
 731       <max value="*" />
 732       <base>
 733         <path value="MedicinalProduct.contact" />
 734         <min value="0" />
 735         <max value="*" />
 736       </base>
 737       <type>
 738         <code value="Reference" />
 739         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
 740         <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole" />
 741       </type>
 742       <constraint>
 743         <key value="ele-1" />
 744         <severity value="error" />
 745         <human value="All FHIR elements must have a @value or children" />
 746         <expression value="hasValue() or (children().count() > id.count())" />
 747         <xpath value="@value|f:*|h:div" />
 748         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 749       </constraint>
 750       <isModifier value="false" />
 751       <isSummary value="true" />
 752     </element>
 753     <element id="MedicinalProduct.clinicalTrial">
 754       <path value="MedicinalProduct.clinicalTrial" />
 755       <short value="Clinical trials or studies that this product is involved in" />
 756       <definition value="Clinical trials or studies that this product is involved in." />
 757       <min value="0" />
 758       <max value="*" />
 759       <base>
 760         <path value="MedicinalProduct.clinicalTrial" />
 761         <min value="0" />
 762         <max value="*" />
 763       </base>
 764       <type>
 765         <code value="Reference" />
 766         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy" />
 767       </type>
 768       <constraint>
 769         <key value="ele-1" />
 770         <severity value="error" />
 771         <human value="All FHIR elements must have a @value or children" />
 772         <expression value="hasValue() or (children().count() > id.count())" />
 773         <xpath value="@value|f:*|h:div" />
 774         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 775       </constraint>
 776       <isModifier value="false" />
 777       <isSummary value="true" />
 778     </element>
 779     <element id="MedicinalProduct.name">
 780       <path value="MedicinalProduct.name" />
 781       <short value="The product's name, including full name and possibly coded parts" />
 782       <definition value="The product's name, including full name and possibly coded parts." />
 783       <min value="1" />
 784       <max value="*" />
 785       <base>
 786         <path value="MedicinalProduct.name" />
 787         <min value="1" />
 788         <max value="*" />
 789       </base>
 790       <type>
 791         <code value="BackboneElement" />
 792       </type>
 793       <constraint>
 794         <key value="ele-1" />
 795         <severity value="error" />
 796         <human value="All FHIR elements must have a @value or children" />
 797         <expression value="hasValue() or (children().count() > id.count())" />
 798         <xpath value="@value|f:*|h:div" />
 799         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 800       </constraint>
 801       <isModifier value="false" />
 802       <isSummary value="true" />
 803     </element>
 804     <element id="MedicinalProduct.name.id">
 805       <path value="MedicinalProduct.name.id" />
 806       <representation value="xmlAttr" />
 807       <short value="Unique id for inter-element referencing" />
 808       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
 809       <min value="0" />
 810       <max value="1" />
 811       <base>
 812         <path value="Element.id" />
 813         <min value="0" />
 814         <max value="1" />
 815       </base>
 816       <type>
 817         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
 818           <valueUrl value="string" />
 819         </extension>
 820         <code value="http://hl7.org/fhirpath/System.String" />
 821       </type>
 822       <isModifier value="false" />
 823       <isSummary value="false" />
 824       <mapping>
 825         <identity value="rim" />
 826         <map value="n/a" />
 827       </mapping>
 828     </element>
 829     <element id="MedicinalProduct.name.extension">
 830       <path value="MedicinalProduct.name.extension" />
 831       <short value="Additional content defined by implementations" />
 832       <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 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." />
 833       <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." />
 834       <alias value="extensions" />
 835       <alias value="user content" />
 836       <min value="0" />
 837       <max value="*" />
 838       <base>
 839         <path value="Element.extension" />
 840         <min value="0" />
 841         <max value="*" />
 842       </base>
 843       <type>
 844         <code value="Extension" />
 845       </type>
 846       <constraint>
 847         <key value="ele-1" />
 848         <severity value="error" />
 849         <human value="All FHIR elements must have a @value or children" />
 850         <expression value="hasValue() or (children().count() > id.count())" />
 851         <xpath value="@value|f:*|h:div" />
 852         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 853       </constraint>
 854       <constraint>
 855         <key value="ext-1" />
 856         <severity value="error" />
 857         <human value="Must have either extensions or value[x], not both" />
 858         <expression value="extension.exists() != value.exists()" />
 859         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
 860         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 861       </constraint>
 862       <isModifier value="false" />
 863       <isSummary value="false" />
 864       <mapping>
 865         <identity value="rim" />
 866         <map value="n/a" />
 867       </mapping>
 868     </element>
 869     <element id="MedicinalProduct.name.modifierExtension">
 870       <path value="MedicinalProduct.name.modifierExtension" />
 871       <short value="Extensions that cannot be ignored even if unrecognized" />
 872       <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 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)." />
 873       <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." />
 874       <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)." />
 875       <alias value="extensions" />
 876       <alias value="user content" />
 877       <alias value="modifiers" />
 878       <min value="0" />
 879       <max value="*" />
 880       <base>
 881         <path value="BackboneElement.modifierExtension" />
 882         <min value="0" />
 883         <max value="*" />
 884       </base>
 885       <type>
 886         <code value="Extension" />
 887       </type>
 888       <constraint>
 889         <key value="ele-1" />
 890         <severity value="error" />
 891         <human value="All FHIR elements must have a @value or children" />
 892         <expression value="hasValue() or (children().count() > id.count())" />
 893         <xpath value="@value|f:*|h:div" />
 894         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 895       </constraint>
 896       <constraint>
 897         <key value="ext-1" />
 898         <severity value="error" />
 899         <human value="Must have either extensions or value[x], not both" />
 900         <expression value="extension.exists() != value.exists()" />
 901         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
 902         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
 903       </constraint>
 904       <isModifier value="true" />
 905       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
 906       <isSummary value="true" />
 907       <mapping>
 908         <identity value="rim" />
 909         <map value="N/A" />
 910       </mapping>
 911     </element>
 912     <element id="MedicinalProduct.name.productName">
 913       <path value="MedicinalProduct.name.productName" />
 914       <short value="The full product name" />
 915       <definition value="The full product name." />
 916       <min value="1" />
 917       <max value="1" />
 918       <base>
 919         <path value="MedicinalProduct.name.productName" />
 920         <min value="1" />
 921         <max value="1" />
 922       </base>
 923       <type>
 924         <code value="string" />
 925       </type>
 926       <constraint>
 927         <key value="ele-1" />
 928         <severity value="error" />
 929         <human value="All FHIR elements must have a @value or children" />
 930         <expression value="hasValue() or (children().count() > id.count())" />
 931         <xpath value="@value|f:*|h:div" />
 932         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 933       </constraint>
 934       <isModifier value="false" />
 935       <isSummary value="true" />
 936     </element>
 937     <element id="MedicinalProduct.name.namePart">
 938       <path value="MedicinalProduct.name.namePart" />
 939       <short value="Coding words or phrases of the name" />
 940       <definition value="Coding words or phrases of the name." />
 941       <min value="0" />
 942       <max value="*" />
 943       <base>
 944         <path value="MedicinalProduct.name.namePart" />
 945         <min value="0" />
 946         <max value="*" />
 947       </base>
 948       <type>
 949         <code value="BackboneElement" />
 950       </type>
 951       <constraint>
 952         <key value="ele-1" />
 953         <severity value="error" />
 954         <human value="All FHIR elements must have a @value or children" />
 955         <expression value="hasValue() or (children().count() > id.count())" />
 956         <xpath value="@value|f:*|h:div" />
 957         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
 958       </constraint>
 959       <isModifier value="false" />
 960       <isSummary value="true" />
 961     </element>
 962     <element id="MedicinalProduct.name.namePart.id">
 963       <path value="MedicinalProduct.name.namePart.id" />
 964       <representation value="xmlAttr" />
 965       <short value="Unique id for inter-element referencing" />
 966       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
 967       <min value="0" />
 968       <max value="1" />
 969       <base>
 970         <path value="Element.id" />
 971         <min value="0" />
 972         <max value="1" />
 973       </base>
 974       <type>
 975         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
 976           <valueUrl value="string" />
 977         </extension>
 978         <code value="http://hl7.org/fhirpath/System.String" />
 979       </type>
 980       <isModifier value="false" />
 981       <isSummary value="false" />
 982       <mapping>
 983         <identity value="rim" />
 984         <map value="n/a" />
 985       </mapping>
 986     </element>
 987     <element id="MedicinalProduct.name.namePart.extension">
 988       <path value="MedicinalProduct.name.namePart.extension" />
 989       <short value="Additional content defined by implementations" />
 990       <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 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." />
 991       <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." />
 992       <alias value="extensions" />
 993       <alias value="user content" />
 994       <min value="0" />
 995       <max value="*" />
 996       <base>
 997         <path value="Element.extension" />
 998         <min value="0" />
 999         <max value="*" />
1000       </base>
1001       <type>
1002         <code value="Extension" />
1003       </type>
1004       <constraint>
1005         <key value="ele-1" />
1006         <severity value="error" />
1007         <human value="All FHIR elements must have a @value or children" />
1008         <expression value="hasValue() or (children().count() > id.count())" />
1009         <xpath value="@value|f:*|h:div" />
1010         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1011       </constraint>
1012       <constraint>
1013         <key value="ext-1" />
1014         <severity value="error" />
1015         <human value="Must have either extensions or value[x], not both" />
1016         <expression value="extension.exists() != value.exists()" />
1017         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
1018         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1019       </constraint>
1020       <isModifier value="false" />
1021       <isSummary value="false" />
1022       <mapping>
1023         <identity value="rim" />
1024         <map value="n/a" />
1025       </mapping>
1026     </element>
1027     <element id="MedicinalProduct.name.namePart.modifierExtension">
1028       <path value="MedicinalProduct.name.namePart.modifierExtension" />
1029       <short value="Extensions that cannot be ignored even if unrecognized" />
1030       <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 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)." />
1031       <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." />
1032       <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)." />
1033       <alias value="extensions" />
1034       <alias value="user content" />
1035       <alias value="modifiers" />
1036       <min value="0" />
1037       <max value="*" />
1038       <base>
1039         <path value="BackboneElement.modifierExtension" />
1040         <min value="0" />
1041         <max value="*" />
1042       </base>
1043       <type>
1044         <code value="Extension" />
1045       </type>
1046       <constraint>
1047         <key value="ele-1" />
1048         <severity value="error" />
1049         <human value="All FHIR elements must have a @value or children" />
1050         <expression value="hasValue() or (children().count() > id.count())" />
1051         <xpath value="@value|f:*|h:div" />
1052         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1053       </constraint>
1054       <constraint>
1055         <key value="ext-1" />
1056         <severity value="error" />
1057         <human value="Must have either extensions or value[x], not both" />
1058         <expression value="extension.exists() != value.exists()" />
1059         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
1060         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1061       </constraint>
1062       <isModifier value="true" />
1063       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
1064       <isSummary value="true" />
1065       <mapping>
1066         <identity value="rim" />
1067         <map value="N/A" />
1068       </mapping>
1069     </element>
1070     <element id="MedicinalProduct.name.namePart.part">
1071       <path value="MedicinalProduct.name.namePart.part" />
1072       <short value="A fragment of a product name" />
1073       <definition value="A fragment of a product name." />
1074       <min value="1" />
1075       <max value="1" />
1076       <base>
1077         <path value="MedicinalProduct.name.namePart.part" />
1078         <min value="1" />
1079         <max value="1" />
1080       </base>
1081       <type>
1082         <code value="string" />
1083       </type>
1084       <constraint>
1085         <key value="ele-1" />
1086         <severity value="error" />
1087         <human value="All FHIR elements must have a @value or children" />
1088         <expression value="hasValue() or (children().count() > id.count())" />
1089         <xpath value="@value|f:*|h:div" />
1090         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1091       </constraint>
1092       <isModifier value="false" />
1093       <isSummary value="true" />
1094     </element>
1095     <element id="MedicinalProduct.name.namePart.type">
1096       <path value="MedicinalProduct.name.namePart.type" />
1097       <short value="Idenifying type for this part of the name (e.g. strength part)" />
1098       <definition value="Idenifying type for this part of the name (e.g. strength part)." />
1099       <min value="1" />
1100       <max value="1" />
1101       <base>
1102         <path value="MedicinalProduct.name.namePart.type" />
1103         <min value="1" />
1104         <max value="1" />
1105       </base>
1106       <type>
1107         <code value="Coding" />
1108       </type>
1109       <constraint>
1110         <key value="ele-1" />
1111         <severity value="error" />
1112         <human value="All FHIR elements must have a @value or children" />
1113         <expression value="hasValue() or (children().count() > id.count())" />
1114         <xpath value="@value|f:*|h:div" />
1115         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1116       </constraint>
1117       <isModifier value="false" />
1118       <isSummary value="true" />
1119     </element>
1120     <element id="MedicinalProduct.name.countryLanguage">
1121       <path value="MedicinalProduct.name.countryLanguage" />
1122       <short value="Country where the name applies" />
1123       <definition value="Country where the name applies." />
1124       <min value="0" />
1125       <max value="*" />
1126       <base>
1127         <path value="MedicinalProduct.name.countryLanguage" />
1128         <min value="0" />
1129         <max value="*" />
1130       </base>
1131       <type>
1132         <code value="BackboneElement" />
1133       </type>
1134       <constraint>
1135         <key value="ele-1" />
1136         <severity value="error" />
1137         <human value="All FHIR elements must have a @value or children" />
1138         <expression value="hasValue() or (children().count() > id.count())" />
1139         <xpath value="@value|f:*|h:div" />
1140         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1141       </constraint>
1142       <isModifier value="false" />
1143       <isSummary value="true" />
1144     </element>
1145     <element id="MedicinalProduct.name.countryLanguage.id">
1146       <path value="MedicinalProduct.name.countryLanguage.id" />
1147       <representation value="xmlAttr" />
1148       <short value="Unique id for inter-element referencing" />
1149       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
1150       <min value="0" />
1151       <max value="1" />
1152       <base>
1153         <path value="Element.id" />
1154         <min value="0" />
1155         <max value="1" />
1156       </base>
1157       <type>
1158         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
1159           <valueUrl value="string" />
1160         </extension>
1161         <code value="http://hl7.org/fhirpath/System.String" />
1162       </type>
1163       <isModifier value="false" />
1164       <isSummary value="false" />
1165       <mapping>
1166         <identity value="rim" />
1167         <map value="n/a" />
1168       </mapping>
1169     </element>
1170     <element id="MedicinalProduct.name.countryLanguage.extension">
1171       <path value="MedicinalProduct.name.countryLanguage.extension" />
1172       <short value="Additional content defined by implementations" />
1173       <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 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." />
1174       <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." />
1175       <alias value="extensions" />
1176       <alias value="user content" />
1177       <min value="0" />
1178       <max value="*" />
1179       <base>
1180         <path value="Element.extension" />
1181         <min value="0" />
1182         <max value="*" />
1183       </base>
1184       <type>
1185         <code value="Extension" />
1186       </type>
1187       <constraint>
1188         <key value="ele-1" />
1189         <severity value="error" />
1190         <human value="All FHIR elements must have a @value or children" />
1191         <expression value="hasValue() or (children().count() > id.count())" />
1192         <xpath value="@value|f:*|h:div" />
1193         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1194       </constraint>
1195       <constraint>
1196         <key value="ext-1" />
1197         <severity value="error" />
1198         <human value="Must have either extensions or value[x], not both" />
1199         <expression value="extension.exists() != value.exists()" />
1200         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
1201         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1202       </constraint>
1203       <isModifier value="false" />
1204       <isSummary value="false" />
1205       <mapping>
1206         <identity value="rim" />
1207         <map value="n/a" />
1208       </mapping>
1209     </element>
1210     <element id="MedicinalProduct.name.countryLanguage.modifierExtension">
1211       <path value="MedicinalProduct.name.countryLanguage.modifierExtension" />
1212       <short value="Extensions that cannot be ignored even if unrecognized" />
1213       <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 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)." />
1214       <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." />
1215       <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)." />
1216       <alias value="extensions" />
1217       <alias value="user content" />
1218       <alias value="modifiers" />
1219       <min value="0" />
1220       <max value="*" />
1221       <base>
1222         <path value="BackboneElement.modifierExtension" />
1223         <min value="0" />
1224         <max value="*" />
1225       </base>
1226       <type>
1227         <code value="Extension" />
1228       </type>
1229       <constraint>
1230         <key value="ele-1" />
1231         <severity value="error" />
1232         <human value="All FHIR elements must have a @value or children" />
1233         <expression value="hasValue() or (children().count() > id.count())" />
1234         <xpath value="@value|f:*|h:div" />
1235         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1236       </constraint>
1237       <constraint>
1238         <key value="ext-1" />
1239         <severity value="error" />
1240         <human value="Must have either extensions or value[x], not both" />
1241         <expression value="extension.exists() != value.exists()" />
1242         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
1243         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1244       </constraint>
1245       <isModifier value="true" />
1246       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
1247       <isSummary value="true" />
1248       <mapping>
1249         <identity value="rim" />
1250         <map value="N/A" />
1251       </mapping>
1252     </element>
1253     <element id="MedicinalProduct.name.countryLanguage.country">
1254       <path value="MedicinalProduct.name.countryLanguage.country" />
1255       <short value="Country code for where this name applies" />
1256       <definition value="Country code for where this name applies." />
1257       <min value="1" />
1258       <max value="1" />
1259       <base>
1260         <path value="MedicinalProduct.name.countryLanguage.country" />
1261         <min value="1" />
1262         <max value="1" />
1263       </base>
1264       <type>
1265         <code value="CodeableConcept" />
1266       </type>
1267       <constraint>
1268         <key value="ele-1" />
1269         <severity value="error" />
1270         <human value="All FHIR elements must have a @value or children" />
1271         <expression value="hasValue() or (children().count() > id.count())" />
1272         <xpath value="@value|f:*|h:div" />
1273         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1274       </constraint>
1275       <isModifier value="false" />
1276       <isSummary value="true" />
1277     </element>
1278     <element id="MedicinalProduct.name.countryLanguage.jurisdiction">
1279       <path value="MedicinalProduct.name.countryLanguage.jurisdiction" />
1280       <short value="Jurisdiction code for where this name applies" />
1281       <definition value="Jurisdiction code for where this name applies." />
1282       <min value="0" />
1283       <max value="1" />
1284       <base>
1285         <path value="MedicinalProduct.name.countryLanguage.jurisdiction" />
1286         <min value="0" />
1287         <max value="1" />
1288       </base>
1289       <type>
1290         <code value="CodeableConcept" />
1291       </type>
1292       <constraint>
1293         <key value="ele-1" />
1294         <severity value="error" />
1295         <human value="All FHIR elements must have a @value or children" />
1296         <expression value="hasValue() or (children().count() > id.count())" />
1297         <xpath value="@value|f:*|h:div" />
1298         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1299       </constraint>
1300       <isModifier value="false" />
1301       <isSummary value="true" />
1302     </element>
1303     <element id="MedicinalProduct.name.countryLanguage.language">
1304       <path value="MedicinalProduct.name.countryLanguage.language" />
1305       <short value="Language code for this name" />
1306       <definition value="Language code for this name." />
1307       <min value="1" />
1308       <max value="1" />
1309       <base>
1310         <path value="MedicinalProduct.name.countryLanguage.language" />
1311         <min value="1" />
1312         <max value="1" />
1313       </base>
1314       <type>
1315         <code value="CodeableConcept" />
1316       </type>
1317       <constraint>
1318         <key value="ele-1" />
1319         <severity value="error" />
1320         <human value="All FHIR elements must have a @value or children" />
1321         <expression value="hasValue() or (children().count() > id.count())" />
1322         <xpath value="@value|f:*|h:div" />
1323         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1324       </constraint>
1325       <isModifier value="false" />
1326       <isSummary value="true" />
1327     </element>
1328     <element id="MedicinalProduct.crossReference">
1329       <path value="MedicinalProduct.crossReference" />
1330       <short value="Reference to another product, e.g. for linking authorised to investigational product" />
1331       <definition value="Reference to another product, e.g. for linking authorised to investigational product." />
1332       <min value="0" />
1333       <max value="*" />
1334       <base>
1335         <path value="MedicinalProduct.crossReference" />
1336         <min value="0" />
1337         <max value="*" />
1338       </base>
1339       <type>
1340         <code value="Identifier" />
1341       </type>
1342       <constraint>
1343         <key value="ele-1" />
1344         <severity value="error" />
1345         <human value="All FHIR elements must have a @value or children" />
1346         <expression value="hasValue() or (children().count() > id.count())" />
1347         <xpath value="@value|f:*|h:div" />
1348         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1349       </constraint>
1350       <isModifier value="false" />
1351       <isSummary value="true" />
1352     </element>
1353     <element id="MedicinalProduct.manufacturingBusinessOperation">
1354       <path value="MedicinalProduct.manufacturingBusinessOperation" />
1355       <short value="An operation applied to the product, for manufacturing or adminsitrative purpose" />
1356       <definition value="An operation applied to the product, for manufacturing or adminsitrative purpose." />
1357       <min value="0" />
1358       <max value="*" />
1359       <base>
1360         <path value="MedicinalProduct.manufacturingBusinessOperation" />
1361         <min value="0" />
1362         <max value="*" />
1363       </base>
1364       <type>
1365         <code value="BackboneElement" />
1366       </type>
1367       <constraint>
1368         <key value="ele-1" />
1369         <severity value="error" />
1370         <human value="All FHIR elements must have a @value or children" />
1371         <expression value="hasValue() or (children().count() > id.count())" />
1372         <xpath value="@value|f:*|h:div" />
1373         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1374       </constraint>
1375       <isModifier value="false" />
1376       <isSummary value="true" />
1377     </element>
1378     <element id="MedicinalProduct.manufacturingBusinessOperation.id">
1379       <path value="MedicinalProduct.manufacturingBusinessOperation.id" />
1380       <representation value="xmlAttr" />
1381       <short value="Unique id for inter-element referencing" />
1382       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
1383       <min value="0" />
1384       <max value="1" />
1385       <base>
1386         <path value="Element.id" />
1387         <min value="0" />
1388         <max value="1" />
1389       </base>
1390       <type>
1391         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
1392           <valueUrl value="string" />
1393         </extension>
1394         <code value="http://hl7.org/fhirpath/System.String" />
1395       </type>
1396       <isModifier value="false" />
1397       <isSummary value="false" />
1398       <mapping>
1399         <identity value="rim" />
1400         <map value="n/a" />
1401       </mapping>
1402     </element>
1403     <element id="MedicinalProduct.manufacturingBusinessOperation.extension">
1404       <path value="MedicinalProduct.manufacturingBusinessOperation.extension" />
1405       <short value="Additional content defined by implementations" />
1406       <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 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." />
1407       <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." />
1408       <alias value="extensions" />
1409       <alias value="user content" />
1410       <min value="0" />
1411       <max value="*" />
1412       <base>
1413         <path value="Element.extension" />
1414         <min value="0" />
1415         <max value="*" />
1416       </base>
1417       <type>
1418         <code value="Extension" />
1419       </type>
1420       <constraint>
1421         <key value="ele-1" />
1422         <severity value="error" />
1423         <human value="All FHIR elements must have a @value or children" />
1424         <expression value="hasValue() or (children().count() > id.count())" />
1425         <xpath value="@value|f:*|h:div" />
1426         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1427       </constraint>
1428       <constraint>
1429         <key value="ext-1" />
1430         <severity value="error" />
1431         <human value="Must have either extensions or value[x], not both" />
1432         <expression value="extension.exists() != value.exists()" />
1433         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
1434         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1435       </constraint>
1436       <isModifier value="false" />
1437       <isSummary value="false" />
1438       <mapping>
1439         <identity value="rim" />
1440         <map value="n/a" />
1441       </mapping>
1442     </element>
1443     <element id="MedicinalProduct.manufacturingBusinessOperation.modifierExtension">
1444       <path value="MedicinalProduct.manufacturingBusinessOperation.modifierExtension" />
1445       <short value="Extensions that cannot be ignored even if unrecognized" />
1446       <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 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)." />
1447       <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." />
1448       <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)." />
1449       <alias value="extensions" />
1450       <alias value="user content" />
1451       <alias value="modifiers" />
1452       <min value="0" />
1453       <max value="*" />
1454       <base>
1455         <path value="BackboneElement.modifierExtension" />
1456         <min value="0" />
1457         <max value="*" />
1458       </base>
1459       <type>
1460         <code value="Extension" />
1461       </type>
1462       <constraint>
1463         <key value="ele-1" />
1464         <severity value="error" />
1465         <human value="All FHIR elements must have a @value or children" />
1466         <expression value="hasValue() or (children().count() > id.count())" />
1467         <xpath value="@value|f:*|h:div" />
1468         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1469       </constraint>
1470       <constraint>
1471         <key value="ext-1" />
1472         <severity value="error" />
1473         <human value="Must have either extensions or value[x], not both" />
1474         <expression value="extension.exists() != value.exists()" />
1475         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
1476         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1477       </constraint>
1478       <isModifier value="true" />
1479       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
1480       <isSummary value="true" />
1481       <mapping>
1482         <identity value="rim" />
1483         <map value="N/A" />
1484       </mapping>
1485     </element>
1486     <element id="MedicinalProduct.manufacturingBusinessOperation.operationType">
1487       <path value="MedicinalProduct.manufacturingBusinessOperation.operationType" />
1488       <short value="The type of manufacturing operation" />
1489       <definition value="The type of manufacturing operation." />
1490       <min value="0" />
1491       <max value="1" />
1492       <base>
1493         <path value="MedicinalProduct.manufacturingBusinessOperation.operationType" />
1494         <min value="0" />
1495         <max value="1" />
1496       </base>
1497       <type>
1498         <code value="CodeableConcept" />
1499       </type>
1500       <constraint>
1501         <key value="ele-1" />
1502         <severity value="error" />
1503         <human value="All FHIR elements must have a @value or children" />
1504         <expression value="hasValue() or (children().count() > id.count())" />
1505         <xpath value="@value|f:*|h:div" />
1506         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1507       </constraint>
1508       <isModifier value="false" />
1509       <isSummary value="true" />
1510     </element>
1511     <element id="MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber">
1512       <path value="MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber" />
1513       <short value="Regulatory authorization reference number" />
1514       <definition value="Regulatory authorization reference number." />
1515       <min value="0" />
1516       <max value="1" />
1517       <base>
1518         <path value="MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber" />
1519         <min value="0" />
1520         <max value="1" />
1521       </base>
1522       <type>
1523         <code value="Identifier" />
1524       </type>
1525       <constraint>
1526         <key value="ele-1" />
1527         <severity value="error" />
1528         <human value="All FHIR elements must have a @value or children" />
1529         <expression value="hasValue() or (children().count() > id.count())" />
1530         <xpath value="@value|f:*|h:div" />
1531         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1532       </constraint>
1533       <isModifier value="false" />
1534       <isSummary value="true" />
1535     </element>
1536     <element id="MedicinalProduct.manufacturingBusinessOperation.effectiveDate">
1537       <path value="MedicinalProduct.manufacturingBusinessOperation.effectiveDate" />
1538       <short value="Regulatory authorization date" />
1539       <definition value="Regulatory authorization date." />
1540       <min value="0" />
1541       <max value="1" />
1542       <base>
1543         <path value="MedicinalProduct.manufacturingBusinessOperation.effectiveDate" />
1544         <min value="0" />
1545         <max value="1" />
1546       </base>
1547       <type>
1548         <code value="dateTime" />
1549       </type>
1550       <constraint>
1551         <key value="ele-1" />
1552         <severity value="error" />
1553         <human value="All FHIR elements must have a @value or children" />
1554         <expression value="hasValue() or (children().count() > id.count())" />
1555         <xpath value="@value|f:*|h:div" />
1556         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1557       </constraint>
1558       <isModifier value="false" />
1559       <isSummary value="true" />
1560     </element>
1561     <element id="MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator">
1562       <path value="MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator" />
1563       <short value="To indicate if this proces is commercially confidential" />
1564       <definition value="To indicate if this proces is commercially confidential." />
1565       <min value="0" />
1566       <max value="1" />
1567       <base>
1568         <path value="MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator" />
1569         <min value="0" />
1570         <max value="1" />
1571       </base>
1572       <type>
1573         <code value="CodeableConcept" />
1574       </type>
1575       <constraint>
1576         <key value="ele-1" />
1577         <severity value="error" />
1578         <human value="All FHIR elements must have a @value or children" />
1579         <expression value="hasValue() or (children().count() > id.count())" />
1580         <xpath value="@value|f:*|h:div" />
1581         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1582       </constraint>
1583       <isModifier value="false" />
1584       <isSummary value="true" />
1585     </element>
1586     <element id="MedicinalProduct.manufacturingBusinessOperation.manufacturer">
1587       <path value="MedicinalProduct.manufacturingBusinessOperation.manufacturer" />
1588       <short value="The manufacturer or establishment associated with the process" />
1589       <definition value="The manufacturer or establishment associated with the process." />
1590       <min value="0" />
1591       <max value="*" />
1592       <base>
1593         <path value="MedicinalProduct.manufacturingBusinessOperation.manufacturer" />
1594         <min value="0" />
1595         <max value="*" />
1596       </base>
1597       <type>
1598         <code value="Reference" />
1599         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
1600       </type>
1601       <constraint>
1602         <key value="ele-1" />
1603         <severity value="error" />
1604         <human value="All FHIR elements must have a @value or children" />
1605         <expression value="hasValue() or (children().count() > id.count())" />
1606         <xpath value="@value|f:*|h:div" />
1607         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1608       </constraint>
1609       <isModifier value="false" />
1610       <isSummary value="true" />
1611     </element>
1612     <element id="MedicinalProduct.manufacturingBusinessOperation.regulator">
1613       <path value="MedicinalProduct.manufacturingBusinessOperation.regulator" />
1614       <short value="A regulator which oversees the operation" />
1615       <definition value="A regulator which oversees the operation." />
1616       <min value="0" />
1617       <max value="1" />
1618       <base>
1619         <path value="MedicinalProduct.manufacturingBusinessOperation.regulator" />
1620         <min value="0" />
1621         <max value="1" />
1622       </base>
1623       <type>
1624         <code value="Reference" />
1625         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
1626       </type>
1627       <constraint>
1628         <key value="ele-1" />
1629         <severity value="error" />
1630         <human value="All FHIR elements must have a @value or children" />
1631         <expression value="hasValue() or (children().count() > id.count())" />
1632         <xpath value="@value|f:*|h:div" />
1633         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1634       </constraint>
1635       <isModifier value="false" />
1636       <isSummary value="true" />
1637     </element>
1638     <element id="MedicinalProduct.specialDesignation">
1639       <path value="MedicinalProduct.specialDesignation" />
1640       <short value="Indicates if the medicinal product has an orphan designation for the treatment of a rare disease" />
1641       <definition value="Indicates if the medicinal product has an orphan designation for the treatment of a rare disease." />
1642       <min value="0" />
1643       <max value="*" />
1644       <base>
1645         <path value="MedicinalProduct.specialDesignation" />
1646         <min value="0" />
1647         <max value="*" />
1648       </base>
1649       <type>
1650         <code value="BackboneElement" />
1651       </type>
1652       <constraint>
1653         <key value="ele-1" />
1654         <severity value="error" />
1655         <human value="All FHIR elements must have a @value or children" />
1656         <expression value="hasValue() or (children().count() > id.count())" />
1657         <xpath value="@value|f:*|h:div" />
1658         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1659       </constraint>
1660       <isModifier value="false" />
1661       <isSummary value="true" />
1662     </element>
1663     <element id="MedicinalProduct.specialDesignation.id">
1664       <path value="MedicinalProduct.specialDesignation.id" />
1665       <representation value="xmlAttr" />
1666       <short value="Unique id for inter-element referencing" />
1667       <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
1668       <min value="0" />
1669       <max value="1" />
1670       <base>
1671         <path value="Element.id" />
1672         <min value="0" />
1673         <max value="1" />
1674       </base>
1675       <type>
1676         <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
1677           <valueUrl value="string" />
1678         </extension>
1679         <code value="http://hl7.org/fhirpath/System.String" />
1680       </type>
1681       <isModifier value="false" />
1682       <isSummary value="false" />
1683       <mapping>
1684         <identity value="rim" />
1685         <map value="n/a" />
1686       </mapping>
1687     </element>
1688     <element id="MedicinalProduct.specialDesignation.extension">
1689       <path value="MedicinalProduct.specialDesignation.extension" />
1690       <short value="Additional content defined by implementations" />
1691       <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 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." />
1692       <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." />
1693       <alias value="extensions" />
1694       <alias value="user content" />
1695       <min value="0" />
1696       <max value="*" />
1697       <base>
1698         <path value="Element.extension" />
1699         <min value="0" />
1700         <max value="*" />
1701       </base>
1702       <type>
1703         <code value="Extension" />
1704       </type>
1705       <constraint>
1706         <key value="ele-1" />
1707         <severity value="error" />
1708         <human value="All FHIR elements must have a @value or children" />
1709         <expression value="hasValue() or (children().count() > id.count())" />
1710         <xpath value="@value|f:*|h:div" />
1711         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1712       </constraint>
1713       <constraint>
1714         <key value="ext-1" />
1715         <severity value="error" />
1716         <human value="Must have either extensions or value[x], not both" />
1717         <expression value="extension.exists() != value.exists()" />
1718         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
1719         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1720       </constraint>
1721       <isModifier value="false" />
1722       <isSummary value="false" />
1723       <mapping>
1724         <identity value="rim" />
1725         <map value="n/a" />
1726       </mapping>
1727     </element>
1728     <element id="MedicinalProduct.specialDesignation.modifierExtension">
1729       <path value="MedicinalProduct.specialDesignation.modifierExtension" />
1730       <short value="Extensions that cannot be ignored even if unrecognized" />
1731       <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 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)." />
1732       <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." />
1733       <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)." />
1734       <alias value="extensions" />
1735       <alias value="user content" />
1736       <alias value="modifiers" />
1737       <min value="0" />
1738       <max value="*" />
1739       <base>
1740         <path value="BackboneElement.modifierExtension" />
1741         <min value="0" />
1742         <max value="*" />
1743       </base>
1744       <type>
1745         <code value="Extension" />
1746       </type>
1747       <constraint>
1748         <key value="ele-1" />
1749         <severity value="error" />
1750         <human value="All FHIR elements must have a @value or children" />
1751         <expression value="hasValue() or (children().count() > id.count())" />
1752         <xpath value="@value|f:*|h:div" />
1753         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1754       </constraint>
1755       <constraint>
1756         <key value="ext-1" />
1757         <severity value="error" />
1758         <human value="Must have either extensions or value[x], not both" />
1759         <expression value="extension.exists() != value.exists()" />
1760         <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])" />
1761         <source value="http://hl7.org/fhir/StructureDefinition/Extension" />
1762       </constraint>
1763       <isModifier value="true" />
1764       <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
1765       <isSummary value="true" />
1766       <mapping>
1767         <identity value="rim" />
1768         <map value="N/A" />
1769       </mapping>
1770     </element>
1771     <element id="MedicinalProduct.specialDesignation.identifier">
1772       <path value="MedicinalProduct.specialDesignation.identifier" />
1773       <short value="Identifier for the designation, or procedure number" />
1774       <definition value="Identifier for the designation, or procedure number." />
1775       <min value="0" />
1776       <max value="*" />
1777       <base>
1778         <path value="MedicinalProduct.specialDesignation.identifier" />
1779         <min value="0" />
1780         <max value="*" />
1781       </base>
1782       <type>
1783         <code value="Identifier" />
1784       </type>
1785       <constraint>
1786         <key value="ele-1" />
1787         <severity value="error" />
1788         <human value="All FHIR elements must have a @value or children" />
1789         <expression value="hasValue() or (children().count() > id.count())" />
1790         <xpath value="@value|f:*|h:div" />
1791         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1792       </constraint>
1793       <isModifier value="false" />
1794       <isSummary value="true" />
1795     </element>
1796     <element id="MedicinalProduct.specialDesignation.type">
1797       <path value="MedicinalProduct.specialDesignation.type" />
1798       <short value="The type of special designation, e.g. orphan drug, minor use" />
1799       <definition value="The type of special designation, e.g. orphan drug, minor use." />
1800       <min value="0" />
1801       <max value="1" />
1802       <base>
1803         <path value="MedicinalProduct.specialDesignation.type" />
1804         <min value="0" />
1805         <max value="1" />
1806       </base>
1807       <type>
1808         <code value="CodeableConcept" />
1809       </type>
1810       <constraint>
1811         <key value="ele-1" />
1812         <severity value="error" />
1813         <human value="All FHIR elements must have a @value or children" />
1814         <expression value="hasValue() or (children().count() > id.count())" />
1815         <xpath value="@value|f:*|h:div" />
1816         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1817       </constraint>
1818       <isModifier value="false" />
1819       <isSummary value="true" />
1820     </element>
1821     <element id="MedicinalProduct.specialDesignation.intendedUse">
1822       <path value="MedicinalProduct.specialDesignation.intendedUse" />
1823       <short value="The intended use of the product, e.g. prevention, treatment" />
1824       <definition value="The intended use of the product, e.g. prevention, treatment." />
1825       <min value="0" />
1826       <max value="1" />
1827       <base>
1828         <path value="MedicinalProduct.specialDesignation.intendedUse" />
1829         <min value="0" />
1830         <max value="1" />
1831       </base>
1832       <type>
1833         <code value="CodeableConcept" />
1834       </type>
1835       <constraint>
1836         <key value="ele-1" />
1837         <severity value="error" />
1838         <human value="All FHIR elements must have a @value or children" />
1839         <expression value="hasValue() or (children().count() > id.count())" />
1840         <xpath value="@value|f:*|h:div" />
1841         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1842       </constraint>
1843       <isModifier value="false" />
1844       <isSummary value="true" />
1845     </element>
1846     <element id="MedicinalProduct.specialDesignation.indication[x]">
1847       <path value="MedicinalProduct.specialDesignation.indication[x]" />
1848       <short value="Condition for which the medicinal use applies" />
1849       <definition value="Condition for which the medicinal use applies." />
1850       <min value="0" />
1851       <max value="1" />
1852       <base>
1853         <path value="MedicinalProduct.specialDesignation.indication[x]" />
1854         <min value="0" />
1855         <max value="1" />
1856       </base>
1857       <type>
1858         <code value="CodeableConcept" />
1859       </type>
1860       <type>
1861         <code value="Reference" />
1862         <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductIndication" />
1863       </type>
1864       <constraint>
1865         <key value="ele-1" />
1866         <severity value="error" />
1867         <human value="All FHIR elements must have a @value or children" />
1868         <expression value="hasValue() or (children().count() > id.count())" />
1869         <xpath value="@value|f:*|h:div" />
1870         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1871       </constraint>
1872       <isModifier value="false" />
1873       <isSummary value="true" />
1874     </element>
1875     <element id="MedicinalProduct.specialDesignation.status">
1876       <path value="MedicinalProduct.specialDesignation.status" />
1877       <short value="For example granted, pending, expired or withdrawn" />
1878       <definition value="For example granted, pending, expired or withdrawn." />
1879       <min value="0" />
1880       <max value="1" />
1881       <base>
1882         <path value="MedicinalProduct.specialDesignation.status" />
1883         <min value="0" />
1884         <max value="1" />
1885       </base>
1886       <type>
1887         <code value="CodeableConcept" />
1888       </type>
1889       <constraint>
1890         <key value="ele-1" />
1891         <severity value="error" />
1892         <human value="All FHIR elements must have a @value or children" />
1893         <expression value="hasValue() or (children().count() > id.count())" />
1894         <xpath value="@value|f:*|h:div" />
1895         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1896       </constraint>
1897       <isModifier value="false" />
1898       <isSummary value="true" />
1899     </element>
1900     <element id="MedicinalProduct.specialDesignation.date">
1901       <path value="MedicinalProduct.specialDesignation.date" />
1902       <short value="Date when the designation was granted" />
1903       <definition value="Date when the designation was granted." />
1904       <min value="0" />
1905       <max value="1" />
1906       <base>
1907         <path value="MedicinalProduct.specialDesignation.date" />
1908         <min value="0" />
1909         <max value="1" />
1910       </base>
1911       <type>
1912         <code value="dateTime" />
1913       </type>
1914       <constraint>
1915         <key value="ele-1" />
1916         <severity value="error" />
1917         <human value="All FHIR elements must have a @value or children" />
1918         <expression value="hasValue() or (children().count() > id.count())" />
1919         <xpath value="@value|f:*|h:div" />
1920         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1921       </constraint>
1922       <isModifier value="false" />
1923       <isSummary value="true" />
1924     </element>
1925     <element id="MedicinalProduct.specialDesignation.species">
1926       <path value="MedicinalProduct.specialDesignation.species" />
1927       <short value="Animal species for which this applies" />
1928       <definition value="Animal species for which this applies." />
1929       <min value="0" />
1930       <max value="1" />
1931       <base>
1932         <path value="MedicinalProduct.specialDesignation.species" />
1933         <min value="0" />
1934         <max value="1" />
1935       </base>
1936       <type>
1937         <code value="CodeableConcept" />
1938       </type>
1939       <constraint>
1940         <key value="ele-1" />
1941         <severity value="error" />
1942         <human value="All FHIR elements must have a @value or children" />
1943         <expression value="hasValue() or (children().count() > id.count())" />
1944         <xpath value="@value|f:*|h:div" />
1945         <source value="http://hl7.org/fhir/StructureDefinition/Element" />
1946       </constraint>
1947       <isModifier value="false" />
1948       <isSummary value="true" />
1949     </element>
1950   </snapshot>
1951   <differential>
1952     <element id="MedicinalProduct">
1953       <path value="MedicinalProduct" />
1954       <short value="Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)" />
1955       <definition value="Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)." />
1956       <min value="0" />
1957       <max value="*" />
1958     </element>
1959     <element id="MedicinalProduct.identifier">
1960       <path value="MedicinalProduct.identifier" />
1961       <short value="Business identifier for this product. Could be an MPID" />
1962       <definition value="Business identifier for this product. Could be an MPID." />
1963       <alias value="MPID" />
1964       <min value="0" />
1965       <max value="*" />
1966       <type>
1967         <code value="Identifier" />
1968       </type>
1969       <isSummary value="true" />
1970     </element>
1971     <element id="MedicinalProduct.type">
1972       <path value="MedicinalProduct.type" />
1973       <short value="Regulatory type, e.g. Investigational or Authorized" />
1974       <definition value="Regulatory type, e.g. Investigational or Authorized." />
1975       <min value="0" />
1976       <max value="1" />
1977       <type>
1978         <code value="CodeableConcept" />
1979       </type>
1980       <isSummary value="true" />
1981     </element>
1982     <element id="MedicinalProduct.domain">
1983       <path value="MedicinalProduct.domain" />
1984       <short value="If this medicine applies to human or veterinary uses" />
1985       <definition value="If this medicine applies to human or veterinary uses." />
1986       <min value="0" />
1987       <max value="1" />
1988       <type>
1989         <code value="Coding" />
1990       </type>
1991       <isSummary value="true" />
1992     </element>
1993     <element id="MedicinalProduct.combinedPharmaceuticalDoseForm">
1994       <path value="MedicinalProduct.combinedPharmaceuticalDoseForm" />
1995       <short value="The dose form for a single part product, or combined form of a multiple part product" />
1996       <definition value="The dose form for a single part product, or combined form of a multiple part product." />
1997       <min value="0" />
1998       <max value="1" />
1999       <type>
2000         <code value="CodeableConcept" />
2001       </type>
2002       <isSummary value="true" />
2003     </element>
2004     <element id="MedicinalProduct.legalStatusOfSupply">
2005       <path value="MedicinalProduct.legalStatusOfSupply" />
2006       <short value="The legal status of supply of the medicinal product as classified by the regulator" />
2007       <definition value="The legal status of supply of the medicinal product as classified by the regulator." />
2008       <min value="0" />
2009       <max value="1" />
2010       <type>
2011         <code value="CodeableConcept" />
2012       </type>
2013       <isSummary value="true" />
2014     </element>
2015     <element id="MedicinalProduct.additionalMonitoringIndicator">
2016       <path value="MedicinalProduct.additionalMonitoringIndicator" />
2017       <short value="Whether the Medicinal Product is subject to additional monitoring for regulatory reasons" />
2018       <definition value="Whether the Medicinal Product is subject to additional monitoring for regulatory reasons." />
2019       <min value="0" />
2020       <max value="1" />
2021       <type>
2022         <code value="CodeableConcept" />
2023       </type>
2024       <isSummary value="true" />
2025     </element>
2026     <element id="MedicinalProduct.specialMeasures">
2027       <path value="MedicinalProduct.specialMeasures" />
2028       <short value="Whether the Medicinal Product is subject to special measures for regulatory reasons" />
2029       <definition value="Whether the Medicinal Product is subject to special measures for regulatory reasons." />
2030       <min value="0" />
2031       <max value="*" />
2032       <type>
2033         <code value="string" />
2034       </type>
2035       <isSummary value="true" />
2036     </element>
2037     <element id="MedicinalProduct.paediatricUseIndicator">
2038       <path value="MedicinalProduct.paediatricUseIndicator" />
2039       <short value="If authorised for use in children" />
2040       <definition value="If authorised for use in children." />
2041       <min value="0" />
2042       <max value="1" />
2043       <type>
2044         <code value="CodeableConcept" />
2045       </type>
2046       <isSummary value="true" />
2047     </element>
2048     <element id="MedicinalProduct.productClassification">
2049       <path value="MedicinalProduct.productClassification" />
2050       <short value="Allows the product to be classified by various systems" />
2051       <definition value="Allows the product to be classified by various systems." />
2052       <min value="0" />
2053       <max value="*" />
2054       <type>
2055         <code value="CodeableConcept" />
2056       </type>
2057       <isSummary value="true" />
2058     </element>
2059     <element id="MedicinalProduct.marketingStatus">
2060       <path value="MedicinalProduct.marketingStatus" />
2061       <short value="Marketing status of the medicinal product, in contrast to marketing authorizaton" />
2062       <definition value="Marketing status of the medicinal product, in contrast to marketing authorizaton." />
2063       <min value="0" />
2064       <max value="*" />
2065       <type>
2066         <code value="MarketingStatus" />
2067       </type>
2068       <isSummary value="true" />
2069     </element>
2070     <element id="MedicinalProduct.pharmaceuticalProduct">
2071       <path value="MedicinalProduct.pharmaceuticalProduct" />
2072       <short value="Pharmaceutical aspects of product" />
2073       <definition value="Pharmaceutical aspects of product." />
2074       <min value="0" />
2075       <max value="*" />
2076       <type>
2077         <code value="Reference" />
2078         <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductPharmaceutical" />
2079       </type>
2080       <isSummary value="true" />
2081     </element>
2082     <element id="MedicinalProduct.packagedMedicinalProduct">
2083       <path value="MedicinalProduct.packagedMedicinalProduct" />
2084       <short value="Package representation for the product" />
2085       <definition value="Package representation for the product." />
2086       <min value="0" />
2087       <max value="*" />
2088       <type>
2089         <code value="Reference" />
2090         <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductPackaged" />
2091       </type>
2092       <isSummary value="true" />
2093     </element>
2094     <element id="MedicinalProduct.attachedDocument">
2095       <path value="MedicinalProduct.attachedDocument" />
2096       <short value="Supporting documentation, typically for regulatory submission" />
2097       <definition value="Supporting documentation, typically for regulatory submission." />
2098       <min value="0" />
2099       <max value="*" />
2100       <type>
2101         <code value="Reference" />
2102         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference" />
2103       </type>
2104       <isSummary value="true" />
2105     </element>
2106     <element id="MedicinalProduct.masterFile">
2107       <path value="MedicinalProduct.masterFile" />
2108       <short value="A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)" />
2109       <definition value="A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)." />
2110       <min value="0" />
2111       <max value="*" />
2112       <type>
2113         <code value="Reference" />
2114         <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference" />
2115       </type>
2116       <isSummary value="true" />
2117     </element>
2118     <element id="MedicinalProduct.contact">
2119       <path value="MedicinalProduct.contact" />
2120       <short value="A product specific contact, person (in a role), or an organization" />
2121       <definition value="A product specific contact, person (in a role), or an organization." />
2122       <min value="0" />
2123       <max value="*" />
2124       <type>
2125         <code value="Reference" />
2126         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
2127         <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole" />
2128       </type>
2129       <isSummary value="true" />
2130     </element>
2131     <element id="MedicinalProduct.clinicalTrial">
2132       <path value="MedicinalProduct.clinicalTrial" />
2133       <short value="Clinical trials or studies that this product is involved in" />
2134       <definition value="Clinical trials or studies that this product is involved in." />
2135       <min value="0" />
2136       <max value="*" />
2137       <type>
2138         <code value="Reference" />
2139         <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy" />
2140       </type>
2141       <isSummary value="true" />
2142     </element>
2143     <element id="MedicinalProduct.name">
2144       <path value="MedicinalProduct.name" />
2145       <short value="The product's name, including full name and possibly coded parts" />
2146       <definition value="The product's name, including full name and possibly coded parts." />
2147       <min value="1" />
2148       <max value="*" />
2149       <type>
2150         <code value="BackboneElement" />
2151       </type>
2152       <isSummary value="true" />
2153     </element>
2154     <element id="MedicinalProduct.name.productName">
2155       <path value="MedicinalProduct.name.productName" />
2156       <short value="The full product name" />
2157       <definition value="The full product name." />
2158       <min value="1" />
2159       <max value="1" />
2160       <type>
2161         <code value="string" />
2162       </type>
2163       <isSummary value="true" />
2164     </element>
2165     <element id="MedicinalProduct.name.namePart">
2166       <path value="MedicinalProduct.name.namePart" />
2167       <short value="Coding words or phrases of the name" />
2168       <definition value="Coding words or phrases of the name." />
2169       <min value="0" />
2170       <max value="*" />
2171       <type>
2172         <code value="BackboneElement" />
2173       </type>
2174       <isSummary value="true" />
2175     </element>
2176     <element id="MedicinalProduct.name.namePart.part">
2177       <path value="MedicinalProduct.name.namePart.part" />
2178       <short value="A fragment of a product name" />
2179       <definition value="A fragment of a product name." />
2180       <min value="1" />
2181       <max value="1" />
2182       <type>
2183         <code value="string" />
2184       </type>
2185       <isSummary value="true" />
2186     </element>
2187     <element id="MedicinalProduct.name.namePart.type">
2188       <path value="MedicinalProduct.name.namePart.type" />
2189       <short value="Idenifying type for this part of the name (e.g. strength part)" />
2190       <definition value="Idenifying type for this part of the name (e.g. strength part)." />
2191       <min value="1" />
2192       <max value="1" />
2193       <type>
2194         <code value="Coding" />
2195       </type>
2196       <isSummary value="true" />
2197     </element>
2198     <element id="MedicinalProduct.name.countryLanguage">
2199       <path value="MedicinalProduct.name.countryLanguage" />
2200       <short value="Country where the name applies" />
2201       <definition value="Country where the name applies." />
2202       <min value="0" />
2203       <max value="*" />
2204       <type>
2205         <code value="BackboneElement" />
2206       </type>
2207       <isSummary value="true" />
2208     </element>
2209     <element id="MedicinalProduct.name.countryLanguage.country">
2210       <path value="MedicinalProduct.name.countryLanguage.country" />
2211       <short value="Country code for where this name applies" />
2212       <definition value="Country code for where this name applies." />
2213       <min value="1" />
2214       <max value="1" />
2215       <type>
2216         <code value="CodeableConcept" />
2217       </type>
2218       <isSummary value="true" />
2219     </element>
2220     <element id="MedicinalProduct.name.countryLanguage.jurisdiction">
2221       <path value="MedicinalProduct.name.countryLanguage.jurisdiction" />
2222       <short value="Jurisdiction code for where this name applies" />
2223       <definition value="Jurisdiction code for where this name applies." />
2224       <min value="0" />
2225       <max value="1" />
2226       <type>
2227         <code value="CodeableConcept" />
2228       </type>
2229       <isSummary value="true" />
2230     </element>
2231     <element id="MedicinalProduct.name.countryLanguage.language">
2232       <path value="MedicinalProduct.name.countryLanguage.language" />
2233       <short value="Language code for this name" />
2234       <definition value="Language code for this name." />
2235       <min value="1" />
2236       <max value="1" />
2237       <type>
2238         <code value="CodeableConcept" />
2239       </type>
2240       <isSummary value="true" />
2241     </element>
2242     <element id="MedicinalProduct.crossReference">
2243       <path value="MedicinalProduct.crossReference" />
2244       <short value="Reference to another product, e.g. for linking authorised to investigational product" />
2245       <definition value="Reference to another product, e.g. for linking authorised to investigational product." />
2246       <min value="0" />
2247       <max value="*" />
2248       <type>
2249         <code value="Identifier" />
2250       </type>
2251       <isSummary value="true" />
2252     </element>
2253     <element id="MedicinalProduct.manufacturingBusinessOperation">
2254       <path value="MedicinalProduct.manufacturingBusinessOperation" />
2255       <short value="An operation applied to the product, for manufacturing or adminsitrative purpose" />
2256       <definition value="An operation applied to the product, for manufacturing or adminsitrative purpose." />
2257       <min value="0" />
2258       <max value="*" />
2259       <type>
2260         <code value="BackboneElement" />
2261       </type>
2262       <isSummary value="true" />
2263     </element>
2264     <element id="MedicinalProduct.manufacturingBusinessOperation.operationType">
2265       <path value="MedicinalProduct.manufacturingBusinessOperation.operationType" />
2266       <short value="The type of manufacturing operation" />
2267       <definition value="The type of manufacturing operation." />
2268       <min value="0" />
2269       <max value="1" />
2270       <type>
2271         <code value="CodeableConcept" />
2272       </type>
2273       <isSummary value="true" />
2274     </element>
2275     <element id="MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber">
2276       <path value="MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber" />
2277       <short value="Regulatory authorization reference number" />
2278       <definition value="Regulatory authorization reference number." />
2279       <min value="0" />
2280       <max value="1" />
2281       <type>
2282         <code value="Identifier" />
2283       </type>
2284       <isSummary value="true" />
2285     </element>
2286     <element id="MedicinalProduct.manufacturingBusinessOperation.effectiveDate">
2287       <path value="MedicinalProduct.manufacturingBusinessOperation.effectiveDate" />
2288       <short value="Regulatory authorization date" />
2289       <definition value="Regulatory authorization date." />
2290       <min value="0" />
2291       <max value="1" />
2292       <type>
2293         <code value="dateTime" />
2294       </type>
2295       <isSummary value="true" />
2296     </element>
2297     <element id="MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator">
2298       <path value="MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator" />
2299       <short value="To indicate if this proces is commercially confidential" />
2300       <definition value="To indicate if this proces is commercially confidential." />
2301       <min value="0" />
2302       <max value="1" />
2303       <type>
2304         <code value="CodeableConcept" />
2305       </type>
2306       <isSummary value="true" />
2307     </element>
2308     <element id="MedicinalProduct.manufacturingBusinessOperation.manufacturer">
2309       <path value="MedicinalProduct.manufacturingBusinessOperation.manufacturer" />
2310       <short value="The manufacturer or establishment associated with the process" />
2311       <definition value="The manufacturer or establishment associated with the process." />
2312       <min value="0" />
2313       <max value="*" />
2314       <type>
2315         <code value="Reference" />
2316         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
2317       </type>
2318       <isSummary value="true" />
2319     </element>
2320     <element id="MedicinalProduct.manufacturingBusinessOperation.regulator">
2321       <path value="MedicinalProduct.manufacturingBusinessOperation.regulator" />
2322       <short value="A regulator which oversees the operation" />
2323       <definition value="A regulator which oversees the operation." />
2324       <min value="0" />
2325       <max value="1" />
2326       <type>
2327         <code value="Reference" />
2328         <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization" />
2329       </type>
2330       <isSummary value="true" />
2331     </element>
2332     <element id="MedicinalProduct.specialDesignation">
2333       <path value="MedicinalProduct.specialDesignation" />
2334       <short value="Indicates if the medicinal product has an orphan designation for the treatment of a rare disease" />
2335       <definition value="Indicates if the medicinal product has an orphan designation for the treatment of a rare disease." />
2336       <min value="0" />
2337       <max value="*" />
2338       <type>
2339         <code value="BackboneElement" />
2340       </type>
2341       <isSummary value="true" />
2342     </element>
2343     <element id="MedicinalProduct.specialDesignation.identifier">
2344       <path value="MedicinalProduct.specialDesignation.identifier" />
2345       <short value="Identifier for the designation, or procedure number" />
2346       <definition value="Identifier for the designation, or procedure number." />
2347       <min value="0" />
2348       <max value="*" />
2349       <type>
2350         <code value="Identifier" />
2351       </type>
2352       <isSummary value="true" />
2353     </element>
2354     <element id="MedicinalProduct.specialDesignation.type">
2355       <path value="MedicinalProduct.specialDesignation.type" />
2356       <short value="The type of special designation, e.g. orphan drug, minor use" />
2357       <definition value="The type of special designation, e.g. orphan drug, minor use." />
2358       <min value="0" />
2359       <max value="1" />
2360       <type>
2361         <code value="CodeableConcept" />
2362       </type>
2363       <isSummary value="true" />
2364     </element>
2365     <element id="MedicinalProduct.specialDesignation.intendedUse">
2366       <path value="MedicinalProduct.specialDesignation.intendedUse" />
2367       <short value="The intended use of the product, e.g. prevention, treatment" />
2368       <definition value="The intended use of the product, e.g. prevention, treatment." />
2369       <min value="0" />
2370       <max value="1" />
2371       <type>
2372         <code value="CodeableConcept" />
2373       </type>
2374       <isSummary value="true" />
2375     </element>
2376     <element id="MedicinalProduct.specialDesignation.indication[x]">
2377       <path value="MedicinalProduct.specialDesignation.indication[x]" />
2378       <short value="Condition for which the medicinal use applies" />
2379       <definition value="Condition for which the medicinal use applies." />
2380       <min value="0" />
2381       <max value="1" />
2382       <type>
2383         <code value="CodeableConcept" />
2384       </type>
2385       <type>
2386         <code value="Reference" />
2387         <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicinalProductIndication" />
2388       </type>
2389       <isSummary value="true" />
2390     </element>
2391     <element id="MedicinalProduct.specialDesignation.status">
2392       <path value="MedicinalProduct.specialDesignation.status" />
2393       <short value="For example granted, pending, expired or withdrawn" />
2394       <definition value="For example granted, pending, expired or withdrawn." />
2395       <min value="0" />
2396       <max value="1" />
2397       <type>
2398         <code value="CodeableConcept" />
2399       </type>
2400       <isSummary value="true" />
2401     </element>
2402     <element id="MedicinalProduct.specialDesignation.date">
2403       <path value="MedicinalProduct.specialDesignation.date" />
2404       <short value="Date when the designation was granted" />
2405       <definition value="Date when the designation was granted." />
2406       <min value="0" />
2407       <max value="1" />
2408       <type>
2409         <code value="dateTime" />
2410       </type>
2411       <isSummary value="true" />
2412     </element>
2413     <element id="MedicinalProduct.specialDesignation.species">
2414       <path value="MedicinalProduct.specialDesignation.species" />
2415       <short value="Animal species for which this applies" />
2416       <definition value="Animal species for which this applies." />
2417       <min value="0" />
2418       <max value="1" />
2419       <type>
2420         <code value="CodeableConcept" />
2421       </type>
2422       <isSummary value="true" />
2423     </element>
2424   </differential>
2425 </StructureDefinition>