EMA Write PMS API Implementation Guide - Enrichments
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: Application Submission Type - JSON Representation

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