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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemRegulatedAuthorizationCaseType
<?xml version="1.0" encoding="UTF-8"?> <CodeSystem xmlns="http://hl7.org/fhir"> <id value="regulated-authorization-case-type"/> <meta> <lastUpdated value="2023-03-26T15:21:02.749+11:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </meta> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <p> This code system <code> http://hl7.org/fhir/regulated-authorization-case-type</code> defines the following codes: </p> <table class="codes"> <tr> <td style="white-space:nowrap"> <b> Code</b> </td> <td> <b> Display</b> </td> </tr> <tr> <td style="white-space:nowrap">InitialMAA <a name="regulated-authorization-case-type-InitialMAA"> </a> </td> <td> Initial Marketing Authorization Application</td> </tr> <tr> <td style="white-space:nowrap">Variation <a name="regulated-authorization-case-type-Variation"> </a> </td> <td> Variation</td> </tr> <tr> <td style="white-space:nowrap">LineExtension <a name="regulated-authorization-case-type-LineExtension"> </a> </td> <td> Line Extension</td> </tr> <tr> <td style="white-space:nowrap">PSUR <a name="regulated-authorization-case-type-PSUR"> </a> </td> <td> Periodic Safety Update Report</td> </tr> <tr> <td style="white-space:nowrap">Renewal <a name="regulated-authorization-case-type-Renewal"> </a> </td> <td> Renewal</td> </tr> <tr> <td style="white-space:nowrap">Follow-up <a name="regulated-authorization-case-type-Follow-up"> </a> </td> <td> Follow-up Measure</td> </tr> <tr> <td style="white-space:nowrap">100000155699 <a name="regulated-authorization-case-type-100000155699"> </a> </td> <td> Specific Obligation</td> </tr> <tr> <td style="white-space:nowrap">AnnualReassessment <a name="regulated-authorization-case-type-AnnualReassessment"> </a> </td> <td> Annual Reassessment</td> </tr> <tr> <td style="white-space:nowrap">UrgentSafetyRestriction <a name="regulated-authorization-case-type-UrgentSafetyRestriction"> </a> </td> <td> Urgent Safety Restriction</td> </tr> <tr> <td style="white-space:nowrap">PaediatricSubmission <a name="regulated-authorization-case-type-PaediatricSubmission"> </a> </td> <td> Paediatric Submission</td> </tr> <tr> <td style="white-space:nowrap">TransferMA <a name="regulated-authorization-case-type-TransferMA"> </a> </td> <td> Transfer of a marketing authorization</td> </tr> <tr> <td style="white-space:nowrap">LiftingSuspension <a name="regulated-authorization-case-type-LiftingSuspension"> </a> </td> <td> Lifting of a Suspension</td> </tr> <tr> <td style="white-space:nowrap">Withdrawal <a name="regulated-authorization-case-type-Withdrawal"> </a> </td> <td> Withdrawal</td> </tr> <tr> <td style="white-space:nowrap">Reformatting <a name="regulated-authorization-case-type-Reformatting"> </a> </td> <td> Reformatting</td> </tr> <tr> <td style="white-space:nowrap">RMP <a name="regulated-authorization-case-type-RMP"> </a> </td> <td> Risk Management Plan</td> </tr> <tr> <td style="white-space:nowrap">ReviewSuspension <a name="regulated-authorization-case-type-ReviewSuspension"> </a> </td> <td> Review of a Suspension of MA</td> </tr> <tr> <td style="white-space:nowrap">SupplementalInformation <a name="regulated-authorization-case-type-SupplementalInformation"> </a> </td> <td> Supplemental Information</td> </tr> <tr> <td style="white-space:nowrap">RepeatUse <a name="regulated-authorization-case-type-RepeatUse"> </a> </td> <td> Repeat Use Procedure</td> </tr> <tr> <td style="white-space:nowrap">SignalDetection <a name="regulated-authorization-case-type-SignalDetection"> </a> </td> <td> Signal detection</td> </tr> <tr> <td style="white-space:nowrap">FLU <a name="regulated-authorization-case-type-FLU"> </a> </td> <td> FLU STRAIN UPDATE</td> </tr> <tr> <td style="white-space:nowrap">PANDEMIC <a name="regulated-authorization-case-type-PANDEMIC"> </a> </td> <td> PANDEMIC UPDATE</td> </tr> <tr> <td style="white-space:nowrap">Orphan <a name="regulated-authorization-case-type-Orphan"> </a> </td> <td> Orphan Designation Application</td> </tr> </table> </div> </text> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="brr"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="trial-use"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="1"/> </extension> <url value="http://hl7.org/fhir/regulated-authorization-case-type"/> <identifier> <system value="urn:ietf:rfc:3986"/> <value value="urn:oid:2.16.840.1.113883.4.642.4.1910"/> </identifier> <version value="5.0.0"/> <name value="RegulatedAuthorizationCaseType"/> <title value="Regulated Authorization Case Type"/> <status value="active"/> <experimental value="false"/> <date value="2021-01-05T10:01:24+11:00"/> <publisher value="HL7 (FHIR Project)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> <telecom> <system value="email"/> <value value="fhir@lists.hl7.org"/> </telecom> </contact> <description value="RegulatedAuthorizationCaseType"/> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> <display value="World"/> </coding> </jurisdiction> <caseSensitive value="true"/> <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"/> <content value="complete"/> <concept> <code value="InitialMAA"/> <display value="Initial Marketing Authorization Application"/> </concept> <concept> <code value="Variation"/> <display value="Variation"/> </concept> <concept> <code value="LineExtension"/> <display value="Line Extension"/> </concept> <concept> <code value="PSUR"/> <display value="Periodic Safety Update Report"/> </concept> <concept> <code value="Renewal"/> <display value="Renewal"/> </concept> <concept> <code value="Follow-up"/> <display value="Follow-up Measure"/> </concept> <concept> <code value="100000155699"/> <display value="Specific Obligation"/> </concept> <concept> <code value="AnnualReassessment"/> <display value="Annual Reassessment"/> </concept> <concept> <code value="UrgentSafetyRestriction"/> <display value="Urgent Safety Restriction"/> </concept> <concept> <code value="PaediatricSubmission"/> <display value="Paediatric Submission"/> </concept> <concept> <code value="TransferMA"/> <display value="Transfer of a marketing authorization"/> </concept> <concept> <code value="LiftingSuspension"/> <display value="Lifting of a Suspension"/> </concept> <concept> <code value="Withdrawal"/> <display value="Withdrawal"/> </concept> <concept> <code value="Reformatting"/> <display value="Reformatting"/> </concept> <concept> <code value="RMP"/> <display value="Risk Management Plan"/> </concept> <concept> <code value="ReviewSuspension"/> <display value="Review of a Suspension of MA"/> </concept> <concept> <code value="SupplementalInformation"/> <display value="Supplemental Information"/> </concept> <concept> <code value="RepeatUse"/> <display value="Repeat Use Procedure"/> </concept> <concept> <code value="SignalDetection"/> <display value="Signal detection"/> </concept> <concept> <code value="FLU"/> <display value="FLU STRAIN UPDATE"/> </concept> <concept> <code value="PANDEMIC"/> <display value="PANDEMIC UPDATE"/> </concept> <concept> <code value="Orphan"/> <display value="Orphan Designation Application"/> </concept> </CodeSystem>
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R5 hl7.fhir.core#5.0.0 generated on Sun, Mar 26, 2023 15:22+1100.
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