EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build

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: Application Submission Type - XML Representation

Active as of 2025-04-04

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="100000155688"/>
  <meta>
    <versionId value="5.0.0"/>
    <lastUpdated value="2023-08-03T11:35:00.198Z"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem 100000155688</b></p><a name="100000155688"> </a><a name="hc100000155688"> </a><a name="100000155688-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000</p></div><p>This case-sensitive code system <code>http://spor.ema.europa.eu/v1/lists/100000155688</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">100000155689<a name="100000155688-100000155689"> </a></td><td>Initial Marketing Authorisation Application</td></tr><tr><td style="white-space:nowrap">100000155690<a name="100000155688-100000155690"> </a></td><td>Variation Type IA</td></tr><tr><td style="white-space:nowrap">100000155691<a name="100000155688-100000155691"> </a></td><td>Variation Type IAIN</td></tr><tr><td style="white-space:nowrap">100000155692<a name="100000155688-100000155692"> </a></td><td>Variation Type IB</td></tr><tr><td style="white-space:nowrap">100000155693<a name="100000155688-100000155693"> </a></td><td>Variation Type II</td></tr><tr><td style="white-space:nowrap">100000155694<a name="100000155688-100000155694"> </a></td><td>National Variation</td></tr><tr><td style="white-space:nowrap">100000155695<a name="100000155688-100000155695"> </a></td><td>Line Extension</td></tr><tr><td style="white-space:nowrap">100000155696<a name="100000155688-100000155696"> </a></td><td>Periodic Safety Update Report</td></tr><tr><td style="white-space:nowrap">100000155697<a name="100000155688-100000155697"> </a></td><td>Renewal</td></tr><tr><td style="white-space:nowrap">100000155698<a name="100000155688-100000155698"> </a></td><td>Follow-up Measure</td></tr><tr><td style="white-space:nowrap">100000155699<a name="100000155688-100000155699"> </a></td><td>Specific Obligation</td></tr><tr><td style="white-space:nowrap">100000155700<a name="100000155688-100000155700"> </a></td><td>Active Substance Master File</td></tr><tr><td style="white-space:nowrap">100000155701<a name="100000155688-100000155701"> </a></td><td>Plasma Master File</td></tr><tr><td style="white-space:nowrap">100000155702<a name="100000155688-100000155702"> </a></td><td>Referral acc. Article 29, 30, 31, 35 or 107i</td></tr><tr><td style="white-space:nowrap">100000155703<a name="100000155688-100000155703"> </a></td><td>Annual Reassessment</td></tr><tr><td style="white-space:nowrap">100000155704<a name="100000155688-100000155704"> </a></td><td>Urgent Safety Restriction</td></tr><tr><td style="white-space:nowrap">100000155705<a name="100000155688-100000155705"> </a></td><td>Paediatric Submission acc. Article 29</td></tr><tr><td style="white-space:nowrap">100000155706<a name="100000155688-100000155706"> </a></td><td>Paediatric Submission acc. Article 46</td></tr><tr><td style="white-space:nowrap">100000155707<a name="100000155688-100000155707"> </a></td><td>WHO Cooperation acc. Article 58</td></tr><tr><td style="white-space:nowrap">100000155708<a name="100000155688-100000155708"> </a></td><td>Notification acc. Article 61(3)</td></tr><tr><td style="white-space:nowrap">100000155709<a name="100000155688-100000155709"> </a></td><td>Transfer of a marketing authorisation</td></tr><tr><td style="white-space:nowrap">100000155710<a name="100000155688-100000155710"> </a></td><td>Lifting of a Suspension</td></tr><tr><td style="white-space:nowrap">100000155711<a name="100000155688-100000155711"> </a></td><td>Withdrawal</td></tr><tr><td style="white-space:nowrap">100000155713<a name="100000155688-100000155713"> </a></td><td>Risk Management Plan</td></tr><tr><td style="white-space:nowrap">100000155714<a name="100000155688-100000155714"> </a></td><td>Correction to the Published Annexes</td></tr><tr><td style="white-space:nowrap">100000155718<a name="100000155688-100000155718"> </a></td><td>Periodic Safety Update Single Assessment</td></tr><tr><td style="white-space:nowrap">200000002290<a name="100000155688-200000002290"> </a></td><td>Certificate of suitability application to EDQM</td></tr><tr><td style="white-space:nowrap">200000002291<a name="100000155688-200000002291"> </a></td><td>Clinical data for publication – Final Version</td></tr><tr><td style="white-space:nowrap">200000002292<a name="100000155688-200000002292"> </a></td><td>Clinical data for publication – Redacted Proposal</td></tr><tr><td style="white-space:nowrap">200000002293<a name="100000155688-200000002293"> </a></td><td>Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006</td></tr><tr><td style="white-space:nowrap">200000002294<a name="100000155688-200000002294"> </a></td><td>Paediatric investigational plan compliance check</td></tr><tr><td style="white-space:nowrap">200000002295<a name="100000155688-200000002295"> </a></td><td>Paediatric investigational plan deferral</td></tr><tr><td style="white-space:nowrap">200000002296<a name="100000155688-200000002296"> </a></td><td>Paediatric investigational plan submission (Module 1.10)</td></tr><tr><td style="white-space:nowrap">200000002297<a name="100000155688-200000002297"> </a></td><td>Paediatric investigational plan partial waiver</td></tr><tr><td style="white-space:nowrap">200000002298<a name="100000155688-200000002298"> </a></td><td>Paediatric investigational plan waiver</td></tr><tr><td style="white-space:nowrap">200000002299<a name="100000155688-200000002299"> </a></td><td>Annex II condition related to a post-authorisation measure</td></tr><tr><td style="white-space:nowrap">200000002300<a name="100000155688-200000002300"> </a></td><td>Corrective Action/Preventive Action related to a post-authorisation measure</td></tr><tr><td style="white-space:nowrap">200000002301<a name="100000155688-200000002301"> </a></td><td>Legally binding measure related to a post-authorisation measure</td></tr><tr><td style="white-space:nowrap">200000002302<a name="100000155688-200000002302"> </a></td><td>Additional pharmacovigilance activity in the risk-management plan</td></tr><tr><td style="white-space:nowrap">200000002303<a name="100000155688-200000002303"> </a></td><td>Submission of a post-authorisation efficacy study</td></tr><tr><td style="white-space:nowrap">200000002305<a name="100000155688-200000002305"> </a></td><td>Recommendation related to a post-authorisation measure</td></tr><tr><td style="white-space:nowrap">200000002306<a name="100000155688-200000002306"> </a></td><td>Cumulative review following a request related to a post-authorisation measure</td></tr><tr><td style="white-space:nowrap">200000002307<a name="100000155688-200000002307"> </a></td><td>Specific obligation related to a post-authorisation measure</td></tr><tr><td style="white-space:nowrap">200000002308<a name="100000155688-200000002308"> </a></td><td>Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC).</td></tr><tr><td style="white-space:nowrap">200000002309<a name="100000155688-200000002309"> </a></td><td>Submission of a post-authorisation safety study report (according article 107o Dir. 2001/83/EC)</td></tr><tr><td style="white-space:nowrap">200000002310<a name="100000155688-200000002310"> </a></td><td>Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC).</td></tr><tr><td style="white-space:nowrap">200000002311<a name="100000155688-200000002311"> </a></td><td>Referral under Article 107i Dir. 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000002312<a name="100000155688-200000002312"> </a></td><td>Referral under Article 16c (1c) Dir. 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000002313<a name="100000155688-200000002313"> </a></td><td>Referral under Article 16c(4) Dir. 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000002314<a name="100000155688-200000002314"> </a></td><td>Referral under Article 20 Reg (EC) 726/2004</td></tr><tr><td style="white-space:nowrap">200000002315<a name="100000155688-200000002315"> </a></td><td>Referral under Article 29(4) Dir. 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000002316<a name="100000155688-200000002316"> </a></td><td>Referral under Article 29(1) Dir. 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000002317<a name="100000155688-200000002317"> </a></td><td>Referral under Article 13 Commission Reg (EC) 1234/2008</td></tr><tr><td style="white-space:nowrap">200000002318<a name="100000155688-200000002318"> </a></td><td>Referral under Article 29 paediatric Reg (EC) 1901/2006</td></tr><tr><td style="white-space:nowrap">200000002319<a name="100000155688-200000002319"> </a></td><td>Referral under Article 30 Dir. 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000002320<a name="100000155688-200000002320"> </a></td><td>Referral under Article 31 Dir. 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000002321<a name="100000155688-200000002321"> </a></td><td>Referral under Article 35 Dir. 2001/83/EC</td></tr><tr><td style="white-space:nowrap">200000002322<a name="100000155688-200000002322"> </a></td><td>Referral under Article 5(3) Reg (EC) 726/2004</td></tr><tr><td style="white-space:nowrap">200000002323<a name="100000155688-200000002323"> </a></td><td>Repeat Use Procedure</td></tr><tr><td style="white-space:nowrap">200000002324<a name="100000155688-200000002324"> </a></td><td>Signal detection</td></tr><tr><td style="white-space:nowrap">200000002325<a name="100000155688-200000002325"> </a></td><td>no regulatory activity</td></tr><tr><td style="white-space:nowrap">200000003166<a name="100000155688-200000003166"> </a></td><td>Paediatric investigational plan partial deferral</td></tr><tr><td style="white-space:nowrap">200000010406<a name="100000155688-200000010406"> </a></td><td>Sunset Clause</td></tr><tr><td style="white-space:nowrap">200000010407<a name="100000155688-200000010407"> </a></td><td>Parallel Import</td></tr><tr><td style="white-space:nowrap">200000018451<a name="100000155688-200000018451"> </a></td><td>Variation not requiring assessment</td></tr><tr><td style="white-space:nowrap">200000018452<a name="100000155688-200000018452"> </a></td><td>Variation requiring assessment (reduced timetable)</td></tr><tr><td style="white-space:nowrap">200000018453<a name="100000155688-200000018453"> </a></td><td>Variation requiring assessment (standard timetable)</td></tr><tr><td style="white-space:nowrap">200000018454<a name="100000155688-200000018454"> </a></td><td>Variation requiring assessment (extended timetable)</td></tr><tr><td style="white-space:nowrap">200000025603<a name="100000155688-200000025603"> </a></td><td>Registration Application</td></tr><tr><td style="white-space:nowrap">200000025605<a name="100000155688-200000025605"> </a></td><td>Parallel Trade</td></tr><tr><td style="white-space:nowrap">200000026016<a name="100000155688-200000026016"> </a></td><td>Variation Type II Art. 29</td></tr><tr><td style="white-space:nowrap">200000026017<a name="100000155688-200000026017"> </a></td><td>Variation Type IB unforeseen</td></tr><tr><td style="white-space:nowrap">220000000041<a name="100000155688-220000000041"> </a></td><td>Article 45 Referral</td></tr><tr><td style="white-space:nowrap">220000000042<a name="100000155688-220000000042"> </a></td><td>Old Article 18</td></tr><tr><td style="white-space:nowrap">220000000044<a name="100000155688-220000000044"> </a></td><td>Workshare</td></tr><tr><td style="white-space:nowrap">220000000045<a name="100000155688-220000000045"> </a></td><td>Grouped Variation</td></tr><tr><td style="white-space:nowrap">220000000046<a name="100000155688-220000000046"> </a></td><td>IG Variation</td></tr><tr><td style="white-space:nowrap">220000000047<a name="100000155688-220000000047"> </a></td><td>Old Type I Variation</td></tr><tr><td style="white-space:nowrap">220000000048<a name="100000155688-220000000048"> </a></td><td>Switch Conditional to Full</td></tr><tr><td style="white-space:nowrap">220000000049<a name="100000155688-220000000049"> </a></td><td>Old Article 22</td></tr><tr><td style="white-space:nowrap">220000000050<a name="100000155688-220000000050"> </a></td><td>Flu Strain Update</td></tr><tr><td style="white-space:nowrap">220000000051<a name="100000155688-220000000051"> </a></td><td>Pandemic Update</td></tr><tr><td style="white-space:nowrap">220000000052<a name="100000155688-220000000052"> </a></td><td>Old Notification</td></tr><tr><td style="white-space:nowrap">220000000053<a name="100000155688-220000000053"> </a></td><td>Old Type I Following Type II</td></tr><tr><td style="white-space:nowrap">220000000054<a name="100000155688-220000000054"> </a></td><td>Old 2PMF</td></tr><tr><td style="white-space:nowrap">220000000076<a name="100000155688-220000000076"> </a></td><td>Orphan Designation Application</td></tr></table></div>
  </text>
  <url value="http://spor.ema.europa.eu/v1/lists/100000155688"/>
  <version value="1.0.0"/>
  <name value="ApplicationSubmissionTypeCs"/>
  <title value="Application Submission Type"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2025-04-04T16:15:09+01:00"/>
  <publisher value="EMA"/>
  <contact>
    <name value="EMA"/>
    <telecom>
      <system value="url"/>
      <value value="https://support.ema.europa.eu/esc"/>
    </telecom>
  </contact>
  <description value="Application Submission Type"/>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="86"/>
  <concept>
    <code value="100000155689"/>
    <display value="Initial Marketing Authorisation Application"/>
  </concept>
  <concept>
    <code value="100000155690"/>
    <display value="Variation Type IA"/>
  </concept>
  <concept>
    <code value="100000155691"/>
    <display value="Variation Type IAIN"/>
  </concept>
  <concept>
    <code value="100000155692"/>
    <display value="Variation Type IB"/>
  </concept>
  <concept>
    <code value="100000155693"/>
    <display value="Variation Type II"/>
  </concept>
  <concept>
    <code value="100000155694"/>
    <display value="National Variation"/>
  </concept>
  <concept>
    <code value="100000155695"/>
    <display value="Line Extension"/>
  </concept>
  <concept>
    <code value="100000155696"/>
    <display value="Periodic Safety Update Report"/>
  </concept>
  <concept>
    <code value="100000155697"/>
    <display value="Renewal"/>
  </concept>
  <concept>
    <code value="100000155698"/>
    <display value="Follow-up Measure"/>
  </concept>
  <concept>
    <code value="100000155699"/>
    <display value="Specific Obligation"/>
  </concept>
  <concept>
    <code value="100000155700"/>
    <display value="Active Substance Master File"/>
  </concept>
  <concept>
    <code value="100000155701"/>
    <display value="Plasma Master File"/>
  </concept>
  <concept>
    <code value="100000155702"/>
    <display value="Referral acc. Article 29, 30, 31, 35 or 107i"/>
  </concept>
  <concept>
    <code value="100000155703"/>
    <display value="Annual Reassessment"/>
  </concept>
  <concept>
    <code value="100000155704"/>
    <display value="Urgent Safety Restriction"/>
  </concept>
  <concept>
    <code value="100000155705"/>
    <display value="Paediatric Submission acc. Article 29"/>
  </concept>
  <concept>
    <code value="100000155706"/>
    <display value="Paediatric Submission acc. Article 46"/>
  </concept>
  <concept>
    <code value="100000155707"/>
    <display value="WHO Cooperation acc. Article 58"/>
  </concept>
  <concept>
    <code value="100000155708"/>
    <display value="Notification acc. Article 61(3)"/>
  </concept>
  <concept>
    <code value="100000155709"/>
    <display value="Transfer of a marketing authorisation"/>
  </concept>
  <concept>
    <code value="100000155710"/>
    <display value="Lifting of a Suspension"/>
  </concept>
  <concept>
    <code value="100000155711"/>
    <display value="Withdrawal"/>
  </concept>
  <concept>
    <code value="100000155713"/>
    <display value="Risk Management Plan"/>
  </concept>
  <concept>
    <code value="100000155714"/>
    <display value="Correction to the Published Annexes"/>
  </concept>
  <concept>
    <code value="100000155718"/>
    <display value="Periodic Safety Update Single Assessment"/>
  </concept>
  <concept>
    <code value="200000002290"/>
    <display value="Certificate of suitability application to EDQM"/>
  </concept>
  <concept>
    <code value="200000002291"/>
    <display value="Clinical data for publication – Final Version"/>
  </concept>
  <concept>
    <code value="200000002292"/>
    <display value="Clinical data for publication – Redacted Proposal"/>
  </concept>
  <concept>
    <code value="200000002293"/>
    <display
             value="Paediatric investigational plan according to article 7, 8 or 30 of the Reg (EC) 1901/2006"/>
  </concept>
  <concept>
    <code value="200000002294"/>
    <display value="Paediatric investigational plan compliance check"/>
  </concept>
  <concept>
    <code value="200000002295"/>
    <display value="Paediatric investigational plan deferral"/>
  </concept>
  <concept>
    <code value="200000002296"/>
    <display
             value="Paediatric investigational plan submission (Module 1.10)"/>
  </concept>
  <concept>
    <code value="200000002297"/>
    <display value="Paediatric investigational plan partial waiver"/>
  </concept>
  <concept>
    <code value="200000002298"/>
    <display value="Paediatric investigational plan waiver"/>
  </concept>
  <concept>
    <code value="200000002299"/>
    <display
             value="Annex II condition related to a post-authorisation measure"/>
  </concept>
  <concept>
    <code value="200000002300"/>
    <display
             value="Corrective Action/Preventive Action related to a post-authorisation measure"/>
  </concept>
  <concept>
    <code value="200000002301"/>
    <display
             value="Legally binding measure related to a post-authorisation measure"/>
  </concept>
  <concept>
    <code value="200000002302"/>
    <display
             value="Additional pharmacovigilance activity in the risk-management plan"/>
  </concept>
  <concept>
    <code value="200000002303"/>
    <display value="Submission of a post-authorisation efficacy study"/>
  </concept>
  <concept>
    <code value="200000002305"/>
    <display value="Recommendation related to a post-authorisation measure"/>
  </concept>
  <concept>
    <code value="200000002306"/>
    <display
             value="Cumulative review following a request related to a post-authorisation measure"/>
  </concept>
  <concept>
    <code value="200000002307"/>
    <display
             value="Specific obligation related to a post-authorisation measure"/>
  </concept>
  <concept>
    <code value="200000002308"/>
    <display
             value="Submission of a post-authorisation safety study protocol (according article 107n Dir. 2001/83/EC)."/>
  </concept>
  <concept>
    <code value="200000002309"/>
    <display
             value="Submission of a post-authorisation safety study report (according article 107o Dir. 2001/83/EC)"/>
  </concept>
  <concept>
    <code value="200000002310"/>
    <display
             value="Submission of a post-authorisation safety study report (according to article 107q Dir. 2001/83/EC)."/>
  </concept>
  <concept>
    <code value="200000002311"/>
    <display value="Referral under Article 107i Dir. 2001/83/EC"/>
  </concept>
  <concept>
    <code value="200000002312"/>
    <display value="Referral under Article 16c (1c) Dir. 2001/83/EC"/>
  </concept>
  <concept>
    <code value="200000002313"/>
    <display value="Referral under Article 16c(4) Dir. 2001/83/EC"/>
  </concept>
  <concept>
    <code value="200000002314"/>
    <display value="Referral under Article 20 Reg (EC) 726/2004"/>
  </concept>
  <concept>
    <code value="200000002315"/>
    <display value="Referral under Article 29(4) Dir. 2001/83/EC"/>
  </concept>
  <concept>
    <code value="200000002316"/>
    <display value="Referral under Article 29(1) Dir. 2001/83/EC"/>
  </concept>
  <concept>
    <code value="200000002317"/>
    <display value="Referral under Article 13 Commission Reg (EC) 1234/2008"/>
  </concept>
  <concept>
    <code value="200000002318"/>
    <display value="Referral under Article 29 paediatric Reg (EC) 1901/2006"/>
  </concept>
  <concept>
    <code value="200000002319"/>
    <display value="Referral under Article 30 Dir. 2001/83/EC"/>
  </concept>
  <concept>
    <code value="200000002320"/>
    <display value="Referral under Article 31 Dir. 2001/83/EC"/>
  </concept>
  <concept>
    <code value="200000002321"/>
    <display value="Referral under Article 35 Dir. 2001/83/EC"/>
  </concept>
  <concept>
    <code value="200000002322"/>
    <display value="Referral under Article 5(3) Reg (EC) 726/2004"/>
  </concept>
  <concept>
    <code value="200000002323"/>
    <display value="Repeat Use Procedure"/>
  </concept>
  <concept>
    <code value="200000002324"/>
    <display value="Signal detection"/>
  </concept>
  <concept>
    <code value="200000002325"/>
    <display value="no regulatory activity"/>
  </concept>
  <concept>
    <code value="200000003166"/>
    <display value="Paediatric investigational plan partial deferral"/>
  </concept>
  <concept>
    <code value="200000010406"/>
    <display value="Sunset Clause"/>
  </concept>
  <concept>
    <code value="200000010407"/>
    <display value="Parallel Import"/>
  </concept>
  <concept>
    <code value="200000018451"/>
    <display value="Variation not requiring assessment"/>
  </concept>
  <concept>
    <code value="200000018452"/>
    <display value="Variation requiring assessment (reduced timetable)"/>
  </concept>
  <concept>
    <code value="200000018453"/>
    <display value="Variation requiring assessment (standard timetable)"/>
  </concept>
  <concept>
    <code value="200000018454"/>
    <display value="Variation requiring assessment (extended timetable)"/>
  </concept>
  <concept>
    <code value="200000025603"/>
    <display value="Registration Application"/>
  </concept>
  <concept>
    <code value="200000025605"/>
    <display value="Parallel Trade"/>
  </concept>
  <concept>
    <code value="200000026016"/>
    <display value="Variation Type II Art. 29"/>
  </concept>
  <concept>
    <code value="200000026017"/>
    <display value="Variation Type IB unforeseen"/>
  </concept>
  <concept>
    <code value="220000000041"/>
    <display value="Article 45 Referral"/>
  </concept>
  <concept>
    <code value="220000000042"/>
    <display value="Old Article 18"/>
  </concept>
  <concept>
    <code value="220000000044"/>
    <display value="Workshare"/>
  </concept>
  <concept>
    <code value="220000000045"/>
    <display value="Grouped Variation"/>
  </concept>
  <concept>
    <code value="220000000046"/>
    <display value="IG Variation"/>
  </concept>
  <concept>
    <code value="220000000047"/>
    <display value="Old Type I Variation"/>
  </concept>
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